Effectiveness of antibiotic prophylaxis during surgical evacuation of the uterus for miscarriage management in low income countries. (AIMS Trial)

Lead Research Organisation: University of Birmingham
Department Name: Clinical and Experimental Medicine

Abstract

Infection following miscarriage surgery - A GLOBAL PROBLEM:
Globally, 210 million women become pregnant each year, but 33 million of these pregnancies end in a miscarriage. A majority of women with a miscarriage will have surgery. In low income settings, the infection rate after miscarriage surgery has been reported to be as high as 30%. Infection after miscarriage can result in serious illness and death, as well as long term consequences including increased rates of ectopic pregnancy, infertility and persistent pain.

Prophylactic antibiotics - A POTENTIAL SOLUTION:
Prophylactic antibiotics, given before surgery, may improve outcomes. However, for miscarriage surgery, current guidelines from the WHO, UK national guidelines, and national guidelines from low income countries do not recommend prophylactic antibiotics. This is because of limited evidence. We propose that prophylactic antibiotics, used at the time of surgery, may offer a solution to reducing the serious problem of infection following miscarriage.

The existing evidence - A TRIAL IS NEEDED:
A recent review of all the evidence concluded that "there is not enough evidence to evaluate a policy of routine antibiotic prophylaxis to women with incomplete miscarriage" and "There is a real and urgent need to find out whether antibiotics should be routinely used in cases of incomplete miscarriage. The policy and cost implications arising from this research will be tremendous, and randomised clinical trials comparing antibiotics currently in use with no antibiotics are strongly recommended."

The proposed AIMS trial:
The question: Can pelvic infection after miscarriage surgery be reduced by giving antibiotics to women just before surgery?
Study sites: The study will be conducted in 3 countries in Sub-Saharan Africa; Tanzania, Malawi and Uganda. These countries have been chosen as women have the greatest problems with infection after miscarriage in low income countries and this is therefore the place where this research could have the greatest impact to improve health.
What the trial involves: Women having surgery for miscarriage will be invited to participate, and if consent is given, women will be offered a single dose of antibiotics, to be taken by mouth two hours before the surgery. We plan to recruit 2400 women in total over 2 years.
The treatment given will be either antibiotics (400mg doxycycline and 400mg metronidazole) or a dummy pill (placebo). The women and clinician will not know if the tablet is the antibiotic or the dummy pill. By comparing the rate of infection and other problems such as death or admission to hospital during the first 2 weeks after surgery between the groups we can determine if the antibiotics are having any effect. Any women in whom an infection is found will have appropriate treatment and also further tests to identify the cause of the infection.

Clinician support for the trial:
The trial is endorsed by international professional organisations and a survey of 124 practitioners from 23 low income countries overwhelmingly (87.5%) supported the need for the AIMS trial.

User support and acceptability:
Semi-structured interviews with gynaecology inpatients in Blantyre, Malawi and Mbale, Uganda showed there was recognition of the potential problems following miscarriage and that the proposed protocol was acceptable. Participants indicated they would be willing to participate and return for follow up assessments. The trial has also been endorsed by the patient group the Miscarriage Association.

The potential benefits of the trial:
Miscarriage surgery is common, and infective complications are frequent and serious. Prophylactic antibiotics, if found effective, may offer a simple and affordable intervention which could be rapidly implemented to reduce the burden of maternal mortality and disease in low income countries. This may directly address MDG5 (reducing maternal mortality), where progress has been uneven and slow.

Technical Summary

Objective: To evaluate the effects of prophylactic antibiotics (Doxycycline 400mg and metronidazole 400mg, given orally, as a single dose prior to surgery) in women undergoing surgical management of miscarriage in low income countries, with the primary outcome of pelvic infection.

Short title: The AIMS (Antibiotics in Miscarriage Surgery) Trial

Study design:
Randomised, double-blind, placebo-controlled, multicentre, multi-national trial. Unit of randomisation is at the individual patient level.

Study duration:
36 months.

Research sites:
a) Malawi: Queen Elizabeth Central Hospital, Blantyre.
b) Uganda: Mbale Regional Hospital.
c) Tanzania: St Francis Hospital (Ifakara) and Bagamoyo District Hospital.
Trial sponsorship:
University of Birmingham

Trial management:
Jointly hosted by University of Birmingham Clinical Trials Unit (BCTU) and College of Medicine, Blantyre, Vaccine & Clinical Trials Unit (VCTU).

Population:
Women undergoing surgical evacuation of the uterus for miscarriage management are eligible to take part in the study.

Intervention:
Doxycycline 400mg oral and Metronidazole 400mg oral, as single dose, taken 2 hours before surgery.

Control:
Identical placebo

Randomisation:
Computerised third-party randomisation with allocation concealment.

Primary outcome:
Pelvic infection within 14 days of surgery, defined as two or more of a) purulent vaginal discharge, b) pyrexia >38.0, c) uterine tenderness, and d) a white cell count >15x109 /l.

Sample size:
To randomise 2400 women (Will give 90% power at p=0.05 to detect a 4% reduction in absolute risk of pelvic infection from a baseline risk of 10% (a relative risk of 0.6, based on our systematic review of antibiotic prophylaxis in induced abortion surgery)).

Dissemination:
By publication of findings and dissemination through FIGO, WHO, RCOG, National societies, dissemination meetings in all countries and the study website. We will also update the Cochrane review

Planned Impact

If antibiotic prophylaxis is found to be a successful strategy then the principal beneficiaries will be women in low income countries who could be offered this treatment and in future will be at a reduced risk of infection after miscarriage surgery. This could reduce the occurrence of sepsis in these women, thus reducing serious illness, organ failure and death. It may also reduce serious long term complications such as ectopic pregnancy, subfertility and chronic pelvic pain.

Miscarriage and miscarriage surgery are so common (20 million procedures worldwide annually) that this would be a very important finding, with the potential to have a major impact on maternal health. Furthermore, as this is a simple and inexpensive intervention we would expect that our dissemination plan could lead to it being widely and rapidly implemented, with national and international guidelines changed, and clinicians altering their practice. Miscarriage and miscarriage surgery are so common, that it places a major burden on national budgets for maternal health. Reducing post miscarriage complications could therefore lead to increased resources available for other women's health services. If the use of prophylactic antibiotics is not found to be successful then our dissemination plan would similarly ensure that women were not unnecessarily exposed to antibiotics and that health systems were not spending on an unnecessary treatment.

Women recruited to the trial will benefit from the peer support groups established, the provision of the complete World Health Organsiation post abortal care package and careful follow-up during the post operative period, which will ensure any complications are recognised early and treated appropriately. Women with miscarriage at the participating hospitals even if they choose not to participate will benefit from the peer support groups and enhanced training of staff in miscarriage care. We hope to inspire a change in organisational culture with a renewed focus on this important problem. We hope this legacy will last beyond the trial and positively benefit all women with miscarriage in these units.

Staff employed in Africa will be recruited with sensitivity to the need not to distort local health economies or reduce the availability of clinical staff. There will be an emphasis on local capacity building and professional development of these individuals. This will include training, mentorship and active participation in the research process. The particular need for capacity building of the Malawi Vaccine and Trials Unit has been identified and additional money has therefore been sought to support this requirement and also funds for an African trial coordinator at this site, working alongside staff at the Birmingham Clinical Trials Unit have been requested. The trial management structure (Figure 7) uses local trial management organisations not only to maximise efficiency but also to support the need to build local clinical trials capacity.

Organisations

Publications

10 25 50
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Braddick L (2016) A mixed-methods study of barriers and facilitators to the implementation of postpartum hemorrhage guidelines in Uganda. in International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics

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Morris JL (2017) FIGO's updated recommendations for misoprostol used alone in gynecology and obstetrics. in International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics

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Weeks A (2016) New WHO antenatal care model-quality worth paying for? in Lancet (London, England)

 
Title AIMS 
Description This film introduces and explains the importance of the AIMS trial. With a storyboard of pictures from Malawi, Tanzania and Uganda, the video features participating researchers and representatives of supporting organisations working together to evaluate the effects of prophylactic antibiotics in the surgical management of miscarriage in low income countries. 
Type Of Art Film/Video/Animation 
Year Produced 2014 
Impact The film enables a non-specialist audience to understand the urgent requirement for more effective treatments to support miscarriage surgery. 
URL https://m.youtube.com/watch?v=xnc22b_ef_s
 
Title Maternal Health Heroes Campaign 
Description My team assisted the University to produce a series of videos, outdoor advertisements and digital promotions under the "Birmingham Heroes" brand, to raise awareness of our efforts to reduce maternal mortality around the world. 
Type Of Art Artwork 
Year Produced 2017 
Impact The campaign has developed awareness of the commitment of my team and the University of Birmingham more widely, to tackle important global challenges of the 21st Century. 
 
Description WHO RP2 Research Assessment Panel
Geographic Reach Multiple continents/international 
Policy Influence Type Participation in a advisory committee
Impact The RP2 Panel is an invited group of 10 researchers in maternal and child health who assess all the WHO research projects in this area. They meet formally once a year in Geneva as well as reviewing research proposals via email. The projects all relate to research in low and middle income settings.
 
Description 2015 Maternal Sepsis (DARO)
Amount £200,000 (GBP)
Organisation University of Birmingham 
Sector Academic/University
Country United Kingdom
Start 10/2015 
 
Description MSD for Mothers - Maternal Sepsis
Amount £150,000 (GBP)
Organisation Merck 
Sector Private
Country Germany
Start 02/2017 
End 02/2020
 
Description Maternal Sepsis (Ammalife)
Amount £12,000 (GBP)
Organisation Ammalife 
Sector Charity/Non Profit
Country United Kingdom
Start 05/2016 
End 04/2018
 
Description University of Birmingham, DARO scheme
Amount £285,000 (GBP)
Organisation University of Birmingham 
Sector Academic/University
Country United Kingdom
Start 08/2016 
End 08/2019
 
Description AIMS 
Organisation Aga Khan University
Country Pakistan 
Sector Academic/University 
PI Contribution My research team co-ordinated the AIMS trial to evaluate the effects of prophylactic antibiotics in the surgical management of miscarriage in low income countries, considering the primary outcome of pelvic infection.
Collaborator Contribution The AIMS trial was conducted at sites in Malawi, Uganda, Tanzania and Pakistan, with support and guidance from the University of Liverpool, the Liverpool School of Tropical Medicine, the Ifakara Institute of Health and the World Health Organisation. Ammalife contributed specialist expertise in the dissemination of outputs, MedSciNet UK provided data collection and management support, and the Miscarriage Association brought experience in ensuring public and patient involvement.
Impact More than 3400 women were recruited to the trial. Outputs are expected in the coming years.
Start Year 2013
 
Description AIMS 
Organisation Agha Khan Diagnostic Centre Garden
Country Pakistan 
Sector Hospitals 
PI Contribution My research team co-ordinated the AIMS trial to evaluate the effects of prophylactic antibiotics in the surgical management of miscarriage in low income countries, considering the primary outcome of pelvic infection.
Collaborator Contribution The AIMS trial was conducted at sites in Malawi, Uganda, Tanzania and Pakistan, with support and guidance from the University of Liverpool, the Liverpool School of Tropical Medicine, the Ifakara Institute of Health and the World Health Organisation. Ammalife contributed specialist expertise in the dissemination of outputs, MedSciNet UK provided data collection and management support, and the Miscarriage Association brought experience in ensuring public and patient involvement.
Impact More than 3400 women were recruited to the trial. Outputs are expected in the coming years.
Start Year 2013
 
Description AIMS 
Organisation Ammalife
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution My research team co-ordinated the AIMS trial to evaluate the effects of prophylactic antibiotics in the surgical management of miscarriage in low income countries, considering the primary outcome of pelvic infection.
Collaborator Contribution The AIMS trial was conducted at sites in Malawi, Uganda, Tanzania and Pakistan, with support and guidance from the University of Liverpool, the Liverpool School of Tropical Medicine, the Ifakara Institute of Health and the World Health Organisation. Ammalife contributed specialist expertise in the dissemination of outputs, MedSciNet UK provided data collection and management support, and the Miscarriage Association brought experience in ensuring public and patient involvement.
Impact More than 3400 women were recruited to the trial. Outputs are expected in the coming years.
Start Year 2013
 
Description AIMS 
Organisation Bagamoyo District Hospital
Country Tanzania, United Republic of 
Sector Hospitals 
PI Contribution My research team co-ordinated the AIMS trial to evaluate the effects of prophylactic antibiotics in the surgical management of miscarriage in low income countries, considering the primary outcome of pelvic infection.
Collaborator Contribution The AIMS trial was conducted at sites in Malawi, Uganda, Tanzania and Pakistan, with support and guidance from the University of Liverpool, the Liverpool School of Tropical Medicine, the Ifakara Institute of Health and the World Health Organisation. Ammalife contributed specialist expertise in the dissemination of outputs, MedSciNet UK provided data collection and management support, and the Miscarriage Association brought experience in ensuring public and patient involvement.
Impact More than 3400 women were recruited to the trial. Outputs are expected in the coming years.
Start Year 2013
 
Description AIMS 
Organisation Chitenje Maternity Trust
Country Malawi 
Sector Charity/Non Profit 
PI Contribution My research team co-ordinated the AIMS trial to evaluate the effects of prophylactic antibiotics in the surgical management of miscarriage in low income countries, considering the primary outcome of pelvic infection.
Collaborator Contribution The AIMS trial was conducted at sites in Malawi, Uganda, Tanzania and Pakistan, with support and guidance from the University of Liverpool, the Liverpool School of Tropical Medicine, the Ifakara Institute of Health and the World Health Organisation. Ammalife contributed specialist expertise in the dissemination of outputs, MedSciNet UK provided data collection and management support, and the Miscarriage Association brought experience in ensuring public and patient involvement.
Impact More than 3400 women were recruited to the trial. Outputs are expected in the coming years.
Start Year 2013
 
Description AIMS 
Organisation Hospital Ramón y Cajal
Department Clinical Biostatistics Unit
Country Spain 
Sector Hospitals 
PI Contribution My research team co-ordinated the AIMS trial to evaluate the effects of prophylactic antibiotics in the surgical management of miscarriage in low income countries, considering the primary outcome of pelvic infection.
Collaborator Contribution The AIMS trial was conducted at sites in Malawi, Uganda, Tanzania and Pakistan, with support and guidance from the University of Liverpool, the Liverpool School of Tropical Medicine, the Ifakara Institute of Health and the World Health Organisation. Ammalife contributed specialist expertise in the dissemination of outputs, MedSciNet UK provided data collection and management support, and the Miscarriage Association brought experience in ensuring public and patient involvement.
Impact More than 3400 women were recruited to the trial. Outputs are expected in the coming years.
Start Year 2013
 
Description AIMS 
Organisation Ifakara Health Institute
Country Tanzania, United Republic of 
Sector Charity/Non Profit 
PI Contribution My research team co-ordinated the AIMS trial to evaluate the effects of prophylactic antibiotics in the surgical management of miscarriage in low income countries, considering the primary outcome of pelvic infection.
Collaborator Contribution The AIMS trial was conducted at sites in Malawi, Uganda, Tanzania and Pakistan, with support and guidance from the University of Liverpool, the Liverpool School of Tropical Medicine, the Ifakara Institute of Health and the World Health Organisation. Ammalife contributed specialist expertise in the dissemination of outputs, MedSciNet UK provided data collection and management support, and the Miscarriage Association brought experience in ensuring public and patient involvement.
Impact More than 3400 women were recruited to the trial. Outputs are expected in the coming years.
Start Year 2013
 
Description AIMS 
Organisation Karimabad Hospital
Country Pakistan 
Sector Hospitals 
PI Contribution My research team co-ordinated the AIMS trial to evaluate the effects of prophylactic antibiotics in the surgical management of miscarriage in low income countries, considering the primary outcome of pelvic infection.
Collaborator Contribution The AIMS trial was conducted at sites in Malawi, Uganda, Tanzania and Pakistan, with support and guidance from the University of Liverpool, the Liverpool School of Tropical Medicine, the Ifakara Institute of Health and the World Health Organisation. Ammalife contributed specialist expertise in the dissemination of outputs, MedSciNet UK provided data collection and management support, and the Miscarriage Association brought experience in ensuring public and patient involvement.
Impact More than 3400 women were recruited to the trial. Outputs are expected in the coming years.
Start Year 2013
 
Description AIMS 
Organisation Kharader Hospital
Country Pakistan 
Sector Hospitals 
PI Contribution My research team co-ordinated the AIMS trial to evaluate the effects of prophylactic antibiotics in the surgical management of miscarriage in low income countries, considering the primary outcome of pelvic infection.
Collaborator Contribution The AIMS trial was conducted at sites in Malawi, Uganda, Tanzania and Pakistan, with support and guidance from the University of Liverpool, the Liverpool School of Tropical Medicine, the Ifakara Institute of Health and the World Health Organisation. Ammalife contributed specialist expertise in the dissemination of outputs, MedSciNet UK provided data collection and management support, and the Miscarriage Association brought experience in ensuring public and patient involvement.
Impact More than 3400 women were recruited to the trial. Outputs are expected in the coming years.
Start Year 2013
 
Description AIMS 
Organisation Liverpool School of Tropical Medicine
Department International Health
Country United Kingdom 
Sector Academic/University 
PI Contribution My research team co-ordinated the AIMS trial to evaluate the effects of prophylactic antibiotics in the surgical management of miscarriage in low income countries, considering the primary outcome of pelvic infection.
Collaborator Contribution The AIMS trial was conducted at sites in Malawi, Uganda, Tanzania and Pakistan, with support and guidance from the University of Liverpool, the Liverpool School of Tropical Medicine, the Ifakara Institute of Health and the World Health Organisation. Ammalife contributed specialist expertise in the dissemination of outputs, MedSciNet UK provided data collection and management support, and the Miscarriage Association brought experience in ensuring public and patient involvement.
Impact More than 3400 women were recruited to the trial. Outputs are expected in the coming years.
Start Year 2013
 
Description AIMS 
Organisation Mbale Regional Hospital
Country Uganda 
Sector Hospitals 
PI Contribution My research team co-ordinated the AIMS trial to evaluate the effects of prophylactic antibiotics in the surgical management of miscarriage in low income countries, considering the primary outcome of pelvic infection.
Collaborator Contribution The AIMS trial was conducted at sites in Malawi, Uganda, Tanzania and Pakistan, with support and guidance from the University of Liverpool, the Liverpool School of Tropical Medicine, the Ifakara Institute of Health and the World Health Organisation. Ammalife contributed specialist expertise in the dissemination of outputs, MedSciNet UK provided data collection and management support, and the Miscarriage Association brought experience in ensuring public and patient involvement.
Impact More than 3400 women were recruited to the trial. Outputs are expected in the coming years.
Start Year 2013
 
Description AIMS 
Organisation MedSciNet
Country Sweden 
Sector Private 
PI Contribution My research team co-ordinated the AIMS trial to evaluate the effects of prophylactic antibiotics in the surgical management of miscarriage in low income countries, considering the primary outcome of pelvic infection.
Collaborator Contribution The AIMS trial was conducted at sites in Malawi, Uganda, Tanzania and Pakistan, with support and guidance from the University of Liverpool, the Liverpool School of Tropical Medicine, the Ifakara Institute of Health and the World Health Organisation. Ammalife contributed specialist expertise in the dissemination of outputs, MedSciNet UK provided data collection and management support, and the Miscarriage Association brought experience in ensuring public and patient involvement.
Impact More than 3400 women were recruited to the trial. Outputs are expected in the coming years.
Start Year 2013
 
Description AIMS 
Organisation Miscarriage Association
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution My research team co-ordinated the AIMS trial to evaluate the effects of prophylactic antibiotics in the surgical management of miscarriage in low income countries, considering the primary outcome of pelvic infection.
Collaborator Contribution The AIMS trial was conducted at sites in Malawi, Uganda, Tanzania and Pakistan, with support and guidance from the University of Liverpool, the Liverpool School of Tropical Medicine, the Ifakara Institute of Health and the World Health Organisation. Ammalife contributed specialist expertise in the dissemination of outputs, MedSciNet UK provided data collection and management support, and the Miscarriage Association brought experience in ensuring public and patient involvement.
Impact More than 3400 women were recruited to the trial. Outputs are expected in the coming years.
Start Year 2013
 
Description AIMS 
Organisation Mwananyamala Hospital
Country Tanzania, United Republic of 
Sector Hospitals 
PI Contribution My research team co-ordinated the AIMS trial to evaluate the effects of prophylactic antibiotics in the surgical management of miscarriage in low income countries, considering the primary outcome of pelvic infection.
Collaborator Contribution The AIMS trial was conducted at sites in Malawi, Uganda, Tanzania and Pakistan, with support and guidance from the University of Liverpool, the Liverpool School of Tropical Medicine, the Ifakara Institute of Health and the World Health Organisation. Ammalife contributed specialist expertise in the dissemination of outputs, MedSciNet UK provided data collection and management support, and the Miscarriage Association brought experience in ensuring public and patient involvement.
Impact More than 3400 women were recruited to the trial. Outputs are expected in the coming years.
Start Year 2013
 
Description AIMS 
Organisation Queen Elizabeth Central Hospital, Malawi
Country Malawi 
Sector Hospitals 
PI Contribution My research team co-ordinated the AIMS trial to evaluate the effects of prophylactic antibiotics in the surgical management of miscarriage in low income countries, considering the primary outcome of pelvic infection.
Collaborator Contribution The AIMS trial was conducted at sites in Malawi, Uganda, Tanzania and Pakistan, with support and guidance from the University of Liverpool, the Liverpool School of Tropical Medicine, the Ifakara Institute of Health and the World Health Organisation. Ammalife contributed specialist expertise in the dissemination of outputs, MedSciNet UK provided data collection and management support, and the Miscarriage Association brought experience in ensuring public and patient involvement.
Impact More than 3400 women were recruited to the trial. Outputs are expected in the coming years.
Start Year 2013
 
Description AIMS 
Organisation University of Liverpool
Country United Kingdom 
Sector Academic/University 
PI Contribution My research team co-ordinated the AIMS trial to evaluate the effects of prophylactic antibiotics in the surgical management of miscarriage in low income countries, considering the primary outcome of pelvic infection.
Collaborator Contribution The AIMS trial was conducted at sites in Malawi, Uganda, Tanzania and Pakistan, with support and guidance from the University of Liverpool, the Liverpool School of Tropical Medicine, the Ifakara Institute of Health and the World Health Organisation. Ammalife contributed specialist expertise in the dissemination of outputs, MedSciNet UK provided data collection and management support, and the Miscarriage Association brought experience in ensuring public and patient involvement.
Impact More than 3400 women were recruited to the trial. Outputs are expected in the coming years.
Start Year 2013
 
Description AIMS 
Organisation University of Liverpool
Country United Kingdom 
Sector Academic/University 
PI Contribution My research team co-ordinated the AIMS trial to evaluate the effects of prophylactic antibiotics in the surgical management of miscarriage in low income countries, considering the primary outcome of pelvic infection.
Collaborator Contribution The AIMS trial was conducted at sites in Malawi, Uganda, Tanzania and Pakistan, with support and guidance from the University of Liverpool, the Liverpool School of Tropical Medicine, the Ifakara Institute of Health and the World Health Organisation. Ammalife contributed specialist expertise in the dissemination of outputs, MedSciNet UK provided data collection and management support, and the Miscarriage Association brought experience in ensuring public and patient involvement.
Impact More than 3400 women were recruited to the trial. Outputs are expected in the coming years.
Start Year 2013
 
Description AIMS 
Organisation University of Malawi
Department College of Medicine
Country Malawi 
Sector Academic/University 
PI Contribution My research team co-ordinated the AIMS trial to evaluate the effects of prophylactic antibiotics in the surgical management of miscarriage in low income countries, considering the primary outcome of pelvic infection.
Collaborator Contribution The AIMS trial was conducted at sites in Malawi, Uganda, Tanzania and Pakistan, with support and guidance from the University of Liverpool, the Liverpool School of Tropical Medicine, the Ifakara Institute of Health and the World Health Organisation. Ammalife contributed specialist expertise in the dissemination of outputs, MedSciNet UK provided data collection and management support, and the Miscarriage Association brought experience in ensuring public and patient involvement.
Impact More than 3400 women were recruited to the trial. Outputs are expected in the coming years.
Start Year 2013
 
Description AIMS 
Organisation World Health Organization (WHO)
Department Department of Reproductive Health and Research
Country Global 
Sector Academic/University 
PI Contribution My research team co-ordinated the AIMS trial to evaluate the effects of prophylactic antibiotics in the surgical management of miscarriage in low income countries, considering the primary outcome of pelvic infection.
Collaborator Contribution The AIMS trial was conducted at sites in Malawi, Uganda, Tanzania and Pakistan, with support and guidance from the University of Liverpool, the Liverpool School of Tropical Medicine, the Ifakara Institute of Health and the World Health Organisation. Ammalife contributed specialist expertise in the dissemination of outputs, MedSciNet UK provided data collection and management support, and the Miscarriage Association brought experience in ensuring public and patient involvement.
Impact More than 3400 women were recruited to the trial. Outputs are expected in the coming years.
Start Year 2013
 
Description Birmingham-Warwick Global Womens Health 
Organisation Ammalife
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution My research team was involved in leading a collaboration between the Universities of Warwick and Birmingham, and (less closely) the Ifakara Health Institute and UCL Institute for Global Health, for the development of research in global women's health.
Collaborator Contribution The members of this collaboration shared and critically reviewed research proposals and publish syntheses of research in global women's health.
Impact Publication of relevance to the disciplines of gynaecology and obstetrics:DOI 10.1111/1471-0528.13183.
Start Year 2014
 
Description Birmingham-Warwick Global Womens Health 
Organisation Ifakara Health Institute
Country Tanzania, United Republic of 
Sector Charity/Non Profit 
PI Contribution My research team was involved in leading a collaboration between the Universities of Warwick and Birmingham, and (less closely) the Ifakara Health Institute and UCL Institute for Global Health, for the development of research in global women's health.
Collaborator Contribution The members of this collaboration shared and critically reviewed research proposals and publish syntheses of research in global women's health.
Impact Publication of relevance to the disciplines of gynaecology and obstetrics:DOI 10.1111/1471-0528.13183.
Start Year 2014
 
Description Birmingham-Warwick Global Womens Health 
Organisation University College London
Department Institute For Global Health
Country United Kingdom 
Sector Academic/University 
PI Contribution My research team was involved in leading a collaboration between the Universities of Warwick and Birmingham, and (less closely) the Ifakara Health Institute and UCL Institute for Global Health, for the development of research in global women's health.
Collaborator Contribution The members of this collaboration shared and critically reviewed research proposals and publish syntheses of research in global women's health.
Impact Publication of relevance to the disciplines of gynaecology and obstetrics:DOI 10.1111/1471-0528.13183.
Start Year 2014
 
Description Birmingham-Warwick Global Womens Health 
Organisation University of Warwick
Country United Kingdom 
Sector Academic/University 
PI Contribution My research team was involved in leading a collaboration between the Universities of Warwick and Birmingham, and (less closely) the Ifakara Health Institute and UCL Institute for Global Health, for the development of research in global women's health.
Collaborator Contribution The members of this collaboration shared and critically reviewed research proposals and publish syntheses of research in global women's health.
Impact Publication of relevance to the disciplines of gynaecology and obstetrics:DOI 10.1111/1471-0528.13183.
Start Year 2014
 
Description Frank Mussai and Carmen De Santo - Investigation of the role of Myeloid Derived Suppressor Cells in recurrent miscarriage 
Organisation Nora Therapeutics Inc.
Country United States 
Sector Private 
PI Contribution Collaborated with the research group of Frank Mussai and Carmen De Santo to explore the modulation of MDSC number and function by the novel agent NT-100 as part of a phase II study of its use in patents with a history of recurrent miscarriage (RESPONSE trial, sponsored by NORA therapeutics)
Collaborator Contribution They run a research lab specialising in the biology of MDSCs, and the combination of my interest in immunology of pregnancy and links with NORA therapeutics through the RESPONSE trial made this study possible. I am leading the research project and line managing the research technician.
Impact Employment of a research technician, programme of research
Start Year 2015
 
Description Frank Mussai and Carmen De Santo - Investigation of the role of Myeloid Derived Suppressor Cells in recurrent miscarriage 
Organisation University of Birmingham
Country United Kingdom 
Sector Academic/University 
PI Contribution Collaborated with the research group of Frank Mussai and Carmen De Santo to explore the modulation of MDSC number and function by the novel agent NT-100 as part of a phase II study of its use in patents with a history of recurrent miscarriage (RESPONSE trial, sponsored by NORA therapeutics)
Collaborator Contribution They run a research lab specialising in the biology of MDSCs, and the combination of my interest in immunology of pregnancy and links with NORA therapeutics through the RESPONSE trial made this study possible. I am leading the research project and line managing the research technician.
Impact Employment of a research technician, programme of research
Start Year 2015
 
Description Maternal and Newborn Sepsis 
Organisation Aga Khan University
Country Pakistan 
Sector Academic/University 
PI Contribution My team collaborates internationally to raise awareness of maternal and newborn sepsis, and to develop effective diagnostic tools and management strategies.
Collaborator Contribution With our collaborative partners, we aim to build global consensus on key issues such as the definition of maternal sepsis and its validation in low and middle income countries. We also aim to strengthen international communities of healthcare professionals and researchers with expertise of relevance to maternal sepsis.
Impact Outputs are published: DOI 10.1186/s12978-017-0321-6 and http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/maternalsepsis-statement/en/.
Start Year 2015
 
Description Maternal and Newborn Sepsis 
Organisation Center for Perinatal Studies, Rosarino (CREP)
Country Argentina 
Sector Charity/Non Profit 
PI Contribution My team collaborates internationally to raise awareness of maternal and newborn sepsis, and to develop effective diagnostic tools and management strategies.
Collaborator Contribution With our collaborative partners, we aim to build global consensus on key issues such as the definition of maternal sepsis and its validation in low and middle income countries. We also aim to strengthen international communities of healthcare professionals and researchers with expertise of relevance to maternal sepsis.
Impact Outputs are published: DOI 10.1186/s12978-017-0321-6 and http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/maternalsepsis-statement/en/.
Start Year 2015
 
Description Maternal and Newborn Sepsis 
Organisation French Institute of Rabat
Country Morocco 
Sector Academic/University 
PI Contribution My team collaborates internationally to raise awareness of maternal and newborn sepsis, and to develop effective diagnostic tools and management strategies.
Collaborator Contribution With our collaborative partners, we aim to build global consensus on key issues such as the definition of maternal sepsis and its validation in low and middle income countries. We also aim to strengthen international communities of healthcare professionals and researchers with expertise of relevance to maternal sepsis.
Impact Outputs are published: DOI 10.1186/s12978-017-0321-6 and http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/maternalsepsis-statement/en/.
Start Year 2015
 
Description Maternal and Newborn Sepsis 
Organisation Fudan University
Department Department of Maternal, Child and Adolescent Health
Country China 
Sector Hospitals 
PI Contribution My team collaborates internationally to raise awareness of maternal and newborn sepsis, and to develop effective diagnostic tools and management strategies.
Collaborator Contribution With our collaborative partners, we aim to build global consensus on key issues such as the definition of maternal sepsis and its validation in low and middle income countries. We also aim to strengthen international communities of healthcare professionals and researchers with expertise of relevance to maternal sepsis.
Impact Outputs are published: DOI 10.1186/s12978-017-0321-6 and http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/maternalsepsis-statement/en/.
Start Year 2015
 
Description Maternal and Newborn Sepsis 
Organisation Fundacion Clinica Valle del Lili, Cali
Country Colombia 
Sector Hospitals 
PI Contribution My team collaborates internationally to raise awareness of maternal and newborn sepsis, and to develop effective diagnostic tools and management strategies.
Collaborator Contribution With our collaborative partners, we aim to build global consensus on key issues such as the definition of maternal sepsis and its validation in low and middle income countries. We also aim to strengthen international communities of healthcare professionals and researchers with expertise of relevance to maternal sepsis.
Impact Outputs are published: DOI 10.1186/s12978-017-0321-6 and http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/maternalsepsis-statement/en/.
Start Year 2015
 
Description Maternal and Newborn Sepsis 
Organisation International Confederation of Midwives
Country Netherlands 
Sector Charity/Non Profit 
PI Contribution My team collaborates internationally to raise awareness of maternal and newborn sepsis, and to develop effective diagnostic tools and management strategies.
Collaborator Contribution With our collaborative partners, we aim to build global consensus on key issues such as the definition of maternal sepsis and its validation in low and middle income countries. We also aim to strengthen international communities of healthcare professionals and researchers with expertise of relevance to maternal sepsis.
Impact Outputs are published: DOI 10.1186/s12978-017-0321-6 and http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/maternalsepsis-statement/en/.
Start Year 2015
 
Description Maternal and Newborn Sepsis 
Organisation International Federation of Gynecology and Obstetrics (FIGO)
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution My team collaborates internationally to raise awareness of maternal and newborn sepsis, and to develop effective diagnostic tools and management strategies.
Collaborator Contribution With our collaborative partners, we aim to build global consensus on key issues such as the definition of maternal sepsis and its validation in low and middle income countries. We also aim to strengthen international communities of healthcare professionals and researchers with expertise of relevance to maternal sepsis.
Impact Outputs are published: DOI 10.1186/s12978-017-0321-6 and http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/maternalsepsis-statement/en/.
Start Year 2015
 
Description Maternal and Newborn Sepsis 
Organisation Jhpiego
Country United States 
Sector Charity/Non Profit 
PI Contribution My team collaborates internationally to raise awareness of maternal and newborn sepsis, and to develop effective diagnostic tools and management strategies.
Collaborator Contribution With our collaborative partners, we aim to build global consensus on key issues such as the definition of maternal sepsis and its validation in low and middle income countries. We also aim to strengthen international communities of healthcare professionals and researchers with expertise of relevance to maternal sepsis.
Impact Outputs are published: DOI 10.1186/s12978-017-0321-6 and http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/maternalsepsis-statement/en/.
Start Year 2015
 
Description Maternal and Newborn Sepsis 
Organisation Johns Hopkins University
Department Department of International Health
Country United States 
Sector Academic/University 
PI Contribution My team collaborates internationally to raise awareness of maternal and newborn sepsis, and to develop effective diagnostic tools and management strategies.
Collaborator Contribution With our collaborative partners, we aim to build global consensus on key issues such as the definition of maternal sepsis and its validation in low and middle income countries. We also aim to strengthen international communities of healthcare professionals and researchers with expertise of relevance to maternal sepsis.
Impact Outputs are published: DOI 10.1186/s12978-017-0321-6 and http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/maternalsepsis-statement/en/.
Start Year 2015
 
Description Maternal and Newborn Sepsis 
Organisation Khon Kaen University
Country Thailand 
Sector Academic/University 
PI Contribution My team collaborates internationally to raise awareness of maternal and newborn sepsis, and to develop effective diagnostic tools and management strategies.
Collaborator Contribution With our collaborative partners, we aim to build global consensus on key issues such as the definition of maternal sepsis and its validation in low and middle income countries. We also aim to strengthen international communities of healthcare professionals and researchers with expertise of relevance to maternal sepsis.
Impact Outputs are published: DOI 10.1186/s12978-017-0321-6 and http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/maternalsepsis-statement/en/.
Start Year 2015
 
Description Maternal and Newborn Sepsis 
Organisation Leiden University Medical Center
Department Department of Obstetrics and Gynaecology
Country Netherlands 
Sector Hospitals 
PI Contribution My team collaborates internationally to raise awareness of maternal and newborn sepsis, and to develop effective diagnostic tools and management strategies.
Collaborator Contribution With our collaborative partners, we aim to build global consensus on key issues such as the definition of maternal sepsis and its validation in low and middle income countries. We also aim to strengthen international communities of healthcare professionals and researchers with expertise of relevance to maternal sepsis.
Impact Outputs are published: DOI 10.1186/s12978-017-0321-6 and http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/maternalsepsis-statement/en/.
Start Year 2015
 
Description Maternal and Newborn Sepsis 
Organisation Lutheran Aid to Medicine in Bangladesh Hospital
Country Bangladesh 
Sector Hospitals 
PI Contribution My team collaborates internationally to raise awareness of maternal and newborn sepsis, and to develop effective diagnostic tools and management strategies.
Collaborator Contribution With our collaborative partners, we aim to build global consensus on key issues such as the definition of maternal sepsis and its validation in low and middle income countries. We also aim to strengthen international communities of healthcare professionals and researchers with expertise of relevance to maternal sepsis.
Impact Outputs are published: DOI 10.1186/s12978-017-0321-6 and http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/maternalsepsis-statement/en/.
Start Year 2015
 
Description Maternal and Newborn Sepsis 
Organisation St George's University of London
Country United Kingdom 
Sector Academic/University 
PI Contribution My team collaborates internationally to raise awareness of maternal and newborn sepsis, and to develop effective diagnostic tools and management strategies.
Collaborator Contribution With our collaborative partners, we aim to build global consensus on key issues such as the definition of maternal sepsis and its validation in low and middle income countries. We also aim to strengthen international communities of healthcare professionals and researchers with expertise of relevance to maternal sepsis.
Impact Outputs are published: DOI 10.1186/s12978-017-0321-6 and http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/maternalsepsis-statement/en/.
Start Year 2015
 
Description Maternal and Newborn Sepsis 
Organisation UK Sepsis Trust
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution My team collaborates internationally to raise awareness of maternal and newborn sepsis, and to develop effective diagnostic tools and management strategies.
Collaborator Contribution With our collaborative partners, we aim to build global consensus on key issues such as the definition of maternal sepsis and its validation in low and middle income countries. We also aim to strengthen international communities of healthcare professionals and researchers with expertise of relevance to maternal sepsis.
Impact Outputs are published: DOI 10.1186/s12978-017-0321-6 and http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/maternalsepsis-statement/en/.
Start Year 2015
 
Description Maternal and Newborn Sepsis 
Organisation United Nations Population Fund
Country United States 
Sector Public 
PI Contribution My team collaborates internationally to raise awareness of maternal and newborn sepsis, and to develop effective diagnostic tools and management strategies.
Collaborator Contribution With our collaborative partners, we aim to build global consensus on key issues such as the definition of maternal sepsis and its validation in low and middle income countries. We also aim to strengthen international communities of healthcare professionals and researchers with expertise of relevance to maternal sepsis.
Impact Outputs are published: DOI 10.1186/s12978-017-0321-6 and http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/maternalsepsis-statement/en/.
Start Year 2015
 
Description Maternal and Newborn Sepsis 
Organisation University of Aberdeen
Country United Kingdom 
Sector Academic/University 
PI Contribution My team collaborates internationally to raise awareness of maternal and newborn sepsis, and to develop effective diagnostic tools and management strategies.
Collaborator Contribution With our collaborative partners, we aim to build global consensus on key issues such as the definition of maternal sepsis and its validation in low and middle income countries. We also aim to strengthen international communities of healthcare professionals and researchers with expertise of relevance to maternal sepsis.
Impact Outputs are published: DOI 10.1186/s12978-017-0321-6 and http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/maternalsepsis-statement/en/.
Start Year 2015
 
Description Maternal and Newborn Sepsis 
Organisation University of Birmingham
Country United Kingdom 
Sector Academic/University 
PI Contribution My team collaborates internationally to raise awareness of maternal and newborn sepsis, and to develop effective diagnostic tools and management strategies.
Collaborator Contribution With our collaborative partners, we aim to build global consensus on key issues such as the definition of maternal sepsis and its validation in low and middle income countries. We also aim to strengthen international communities of healthcare professionals and researchers with expertise of relevance to maternal sepsis.
Impact Outputs are published: DOI 10.1186/s12978-017-0321-6 and http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/maternalsepsis-statement/en/.
Start Year 2015
 
Description Maternal and Newborn Sepsis 
Organisation University of Nairobi
Department Department of Obstetrics and Gynaecology
Country Kenya 
Sector Hospitals 
PI Contribution My team collaborates internationally to raise awareness of maternal and newborn sepsis, and to develop effective diagnostic tools and management strategies.
Collaborator Contribution With our collaborative partners, we aim to build global consensus on key issues such as the definition of maternal sepsis and its validation in low and middle income countries. We also aim to strengthen international communities of healthcare professionals and researchers with expertise of relevance to maternal sepsis.
Impact Outputs are published: DOI 10.1186/s12978-017-0321-6 and http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/maternalsepsis-statement/en/.
Start Year 2015
 
Description Maternal and Newborn Sepsis 
Organisation University of Oxford
Department National Perinatal Epidemiology Unit Oxford
Country United Kingdom 
Sector Academic/University 
PI Contribution My team collaborates internationally to raise awareness of maternal and newborn sepsis, and to develop effective diagnostic tools and management strategies.
Collaborator Contribution With our collaborative partners, we aim to build global consensus on key issues such as the definition of maternal sepsis and its validation in low and middle income countries. We also aim to strengthen international communities of healthcare professionals and researchers with expertise of relevance to maternal sepsis.
Impact Outputs are published: DOI 10.1186/s12978-017-0321-6 and http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/maternalsepsis-statement/en/.
Start Year 2015
 
Description Maternal and Newborn Sepsis 
Organisation University of Pretoria
Department MRC Maternal and Infant Health Care Strategies Research Unit
Country South Africa 
Sector Academic/University 
PI Contribution My team collaborates internationally to raise awareness of maternal and newborn sepsis, and to develop effective diagnostic tools and management strategies.
Collaborator Contribution With our collaborative partners, we aim to build global consensus on key issues such as the definition of maternal sepsis and its validation in low and middle income countries. We also aim to strengthen international communities of healthcare professionals and researchers with expertise of relevance to maternal sepsis.
Impact Outputs are published: DOI 10.1186/s12978-017-0321-6 and http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/maternalsepsis-statement/en/.
Start Year 2015
 
Description Maternal and Newborn Sepsis 
Organisation University of Sao Paulo
Department Department of Social Medicine
Country Brazil 
Sector Academic/University 
PI Contribution My team collaborates internationally to raise awareness of maternal and newborn sepsis, and to develop effective diagnostic tools and management strategies.
Collaborator Contribution With our collaborative partners, we aim to build global consensus on key issues such as the definition of maternal sepsis and its validation in low and middle income countries. We also aim to strengthen international communities of healthcare professionals and researchers with expertise of relevance to maternal sepsis.
Impact Outputs are published: DOI 10.1186/s12978-017-0321-6 and http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/maternalsepsis-statement/en/.
Start Year 2015
 
Description Maternal and Newborn Sepsis 
Organisation University of Uyo Teaching Hospital
Country Nigeria 
Sector Hospitals 
PI Contribution My team collaborates internationally to raise awareness of maternal and newborn sepsis, and to develop effective diagnostic tools and management strategies.
Collaborator Contribution With our collaborative partners, we aim to build global consensus on key issues such as the definition of maternal sepsis and its validation in low and middle income countries. We also aim to strengthen international communities of healthcare professionals and researchers with expertise of relevance to maternal sepsis.
Impact Outputs are published: DOI 10.1186/s12978-017-0321-6 and http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/maternalsepsis-statement/en/.
Start Year 2015
 
Description Maternal and Newborn Sepsis 
Organisation University of Washington
Department Earth and Space Sciences
Country United States 
Sector Academic/University 
PI Contribution My team collaborates internationally to raise awareness of maternal and newborn sepsis, and to develop effective diagnostic tools and management strategies.
Collaborator Contribution With our collaborative partners, we aim to build global consensus on key issues such as the definition of maternal sepsis and its validation in low and middle income countries. We also aim to strengthen international communities of healthcare professionals and researchers with expertise of relevance to maternal sepsis.
Impact Outputs are published: DOI 10.1186/s12978-017-0321-6 and http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/maternalsepsis-statement/en/.
Start Year 2015
 
Description Maternal and Newborn Sepsis 
Organisation University of the Republic
Department Faculty of Medicine
Country Uruguay 
Sector Academic/University 
PI Contribution My team collaborates internationally to raise awareness of maternal and newborn sepsis, and to develop effective diagnostic tools and management strategies.
Collaborator Contribution With our collaborative partners, we aim to build global consensus on key issues such as the definition of maternal sepsis and its validation in low and middle income countries. We also aim to strengthen international communities of healthcare professionals and researchers with expertise of relevance to maternal sepsis.
Impact Outputs are published: DOI 10.1186/s12978-017-0321-6 and http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/maternalsepsis-statement/en/.
Start Year 2015
 
Description Maternal and Newborn Sepsis 
Organisation World Health Organization (WHO)
Country Global 
Sector Public 
PI Contribution My team collaborates internationally to raise awareness of maternal and newborn sepsis, and to develop effective diagnostic tools and management strategies.
Collaborator Contribution With our collaborative partners, we aim to build global consensus on key issues such as the definition of maternal sepsis and its validation in low and middle income countries. We also aim to strengthen international communities of healthcare professionals and researchers with expertise of relevance to maternal sepsis.
Impact Outputs are published: DOI 10.1186/s12978-017-0321-6 and http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/maternalsepsis-statement/en/.
Start Year 2015
 
Description WHO Collaborating Centre 
Organisation World Health Organization (WHO)
Country Global 
Sector Public 
PI Contribution We are testing and disseminating a sepsis management bundle and tools for the initial care of maternal sepsis, firstly in multiple health facilities in Malawi and subsequently at scale in multiple low resource countries. We are also contributing to evidence-based guidelines for the prevention and treatment of PPH, and developing a bundle for the management of this condition. Finally, we are pursuing evidence synthesis of treatment options managing miscarriages.
Collaborator Contribution The WHO supports our team in tasks above, through operational co-operation and advice in data analysis.
Impact No outputs yet
Start Year 2018
 
Description WHO Collaborating Centre for Research and Research Synthesis in Reproductive Health 
Organisation World Health Organization (WHO)
Department Department of Reproductive Health and Research
Country Global 
Sector Academic/University 
PI Contribution The Terms of Reference are: 1. Collaborate in research synthesis to support the translation of evidence-based research findings into WHO policy and services in the area of maternal and newborn health
Collaborator Contribution To advise on research proposals and protocols, contribute to Trial Steering Groups
Impact The WHO officers contribute to all the research proposals within the Sanyu Research Unit by commenting on the protocols. In addition, Julie Storr was a co-investigator on the BabyGel Study and Metin Gulmezoglu chaired the Steering Committee for INFORM study.
Start Year 2012
 
Description World Health Organisation - maternal sepsis initiative 
Organisation Ammalife
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution I am part of the secretariat which is helping formulate the new maternal sepsis and suspected maternal sepsis definitions. I am leading the team designing the maternal sepsis immediate management bundle. Consensus on the bundle components has been reached through an international modified Delphi process. The implementation toolkits are being completed at an in-country meeting with a broad range of stakeholders in Malawi in May. We hope to pilot the bundle early next year as part of a join initiative with the WHO.
Collaborator Contribution Ammalife £40,000 Philanthropic donation £96,000 University of Birmingham Alumni fund £15,000
Impact No impact yet. Anticipated that once the process has been completed the bundle may become integrated into WHO policy, and could have global impacts.
Start Year 2015
 
Description World Health Organisation - maternal sepsis initiative 
Organisation World Health Organization (WHO)
Department Maternal, Newborn, Child and Adolescent Health
Country Switzerland 
Sector Public 
PI Contribution I am part of the secretariat which is helping formulate the new maternal sepsis and suspected maternal sepsis definitions. I am leading the team designing the maternal sepsis immediate management bundle. Consensus on the bundle components has been reached through an international modified Delphi process. The implementation toolkits are being completed at an in-country meeting with a broad range of stakeholders in Malawi in May. We hope to pilot the bundle early next year as part of a join initiative with the WHO.
Collaborator Contribution Ammalife £40,000 Philanthropic donation £96,000 University of Birmingham Alumni fund £15,000
Impact No impact yet. Anticipated that once the process has been completed the bundle may become integrated into WHO policy, and could have global impacts.
Start Year 2015
 
Title Antibiotics in miscarriage surgery 
Description The AIMS (Antibiotics in Miscarriage Surgery) project proposed that antibiotics given just before miscarriage surgery could reduce the chances of infection, and tested the hypothesis through a large clinical trial in Malawi, Tanzania, Uganda and Pakistan. The study was endorsed by the WHO, FIGO and RCOG, and financially supported by the MRC, Wellcome Trust and UK Department for International Development. 
Type Therapeutic Intervention - Drug
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2013
Development Status Under active development/distribution
Impact Please refer to other sections of the portfolio for further details. 
URL http://www.ammalife.org/research/aims-antibiotics-in-miscarriage-surgery
 
Description #AidWorks Ministerial Visit 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Policymakers/politicians
Results and Impact On Thursday 22nd February 2018 David Lissauer (AIMS Trial Manager) joined a roundtable session with the Rt Hon Alistair Burt MP (Minister of State for International Development) at the University of Birmingham. The ministerial visit was arranged as part of the Department for International Development (DFID) #AidWorks campaign being piloted in the West Midlands. The group shared positive messages about how UK aid is spent and what it achieves, and demonstrated to ministerial delegates how our research addresses current international development challenges.
Year(s) Of Engagement Activity 2018
 
Description Ammalife - AIMS 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Ammalife is disseminating AIMS news to the public via the charity website and other events.

Lay communities are aware and informed about the AIMS Trial.
Year(s) Of Engagement Activity 2013,2014,2015,2016,2017
URL http://www.ammalife.org/research/aims-antibiotics-in-miscarriage-surgery
 
Description Clinical Trials Presentation at IMSR Away Day 2016 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact I was invited to deliver a presentation entitled "Translating Science into Health - Clinical Trials" to the Institute of Metabolism and Systems Research (IMSR) at the University of Birmingham. Questions and discussions increased awareness and interest in the subject.
Year(s) Of Engagement Activity 2016
 
Description Community Sensitisation - AIMS Uganda 
Form Of Engagement Activity Participation in an open day or visit at my research institution
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Patients, carers and/or patient groups
Results and Impact Antibiotic administration is an issue in Uganda so we designed lay materials for distribution from ten rural health centres, to discuss appropriate use of antibiotics and inform local communities about antibiotic resistance. The materials sparked interest and questions from the women attending each clinic.

Women became interested in ourt study, and in learning how to better combat antibiotic resistance and improve maternal health.
Year(s) Of Engagement Activity 2014
 
Description Facebook - AIMS 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact AIMS news is reported via facebook.

The AIMS Trial has gained 67 'Likes' from assorted participants in the research and other supporters.
Year(s) Of Engagement Activity 2014,2015,2016,2017,2018
URL https://www.facebook.com/aimstrial
 
Description GLOW 2012 - AIMS 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Over 100 scientists, doctors, nurses, educators, health promoters, community activists and volunteers interested in achieving safe motherhood attended the first GLOW (Global Women's Health Research Society) Conference in Liverpool on Tuesday 23 October 2012. I (Arri Coomarasamy) co-authored and co-presented a poster entitled Maximising Participant Retention In Maternal Health Trials In Low- And Lower-Middle-Income Countries: A Mixed Methods Study (with colleagues Susannah Waite and David Lissauer). This feature introduced the AIMS trial.

Delegates learned about the work of AIMS and engaged in discussions with the project team.
Year(s) Of Engagement Activity 2012
URL http://www.glowconference.org/glow-2012.html
 
Description GLOW 2013 - AIMS 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Over 100 scientists, doctors, nurses, educators, health promoters, community activists and volunteers interested in achieving safe motherhood attended the second GLOW (Global Women's Health Research Society) Conference in Birmingham on Friday 1 November 2013. This event enabled our team to disseminate news and promote the AIMS project.

Delegates learned about the work of AIMS and engaged in discussions with the project team.
Year(s) Of Engagement Activity 2013
URL http://www.glowconference.org/glow-2013.html
 
Description MAOCO - AIMS 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Over time AIMS team members have inspired, supported and encouraged the professional motivation and self-belief of clinical officers in Malawi, and this cadre of healthcare workers has now established a professional development society (the Malawi Association of Obstetric Clinical Officers, MAOCO) for the purpose of sharing knowledge and expertise.
Year(s) Of Engagement Activity 2015,2016,2017,2018
 
Description Meeting of Collaborators: Inauguration - AIMS 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact The AIMS Inauguration Meeting in early November 2013 brought together researchers from three different continents to learn about one another, to develop the study database and share ideas to facilitate the project.

The AIMS Inauguration Meeting in early November 2013 consolidated teamwork and enabled researchers to prepare audiovisual material to promote the Trial.
Year(s) Of Engagement Activity 2013
 
Description Miscarriage Association - AIMS 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact A representative of the Miscarriage Association - who participates in meetings of the AIMS Trial Steering Committee - regularly reports our news of the project via the Miscarriage Association website and meetings of this organisation.

The Miscarriage Association brings news of the AIMS Trial to the public.
Year(s) Of Engagement Activity 2013,2014,2015,2016,2017
URL http://www.miscarriageassociation.org.uk/
 
Description Mixed methods research on reasons for trial participation - AIMS 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact We carried out mixed methods research to find out: factors influencing Malawian women's decisions of whether to participate in a reproductive health clinical trial; women's understanding of reproductive health trial information; the availability, utilisation and quality of miscarriage care services in Blantyre district; healthcare providers' knowledge and practice of miscarriage care; and treatment seeking behaviours and other determinants of access to care.
Year(s) Of Engagement Activity 2013,2014,2015,2016,2017
 
Description Newsletters - AIMS 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Study participants or study members
Results and Impact Newsletters featuring components such as randomisation rankings, AIMS stars and FAQs were issued regularly (every two months) to participants and researchers in the AIMS trial, to keep everybody abreast of progress and build staff morale.

Collaborators have expressed appreciation of newsletters and researchers have engaged in friendly competition in rates of recruitment between sites, boosting our overall rate of progress. The FAQs of our newsletters are helping researchers and midwives to learn from the practical challenges experienced by peers.
Year(s) Of Engagement Activity 2014,2015,2016,2017
URL http://www.aimstrial.org
 
Description Participant Contact - AIMS 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Study participants or study members
Results and Impact Our researchers in Malawi conducted home visits and meetings to gain a better understanding of the challenges for participants to keep follow up appointments.

Our improved understanding of the reasons for participants to decline or abandon the protocol enables our work together to better address and overcome these issues.
Year(s) Of Engagement Activity 2014,2015
 
Description Peer Support Group - AIMS 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Study participants or study members
Results and Impact From feedback from the recruiting site in Malawi, we initiated a peer support group for women who have experienced a pregnancy loss, and for teenage mothers. Meetings are held every 3 months. Women often attend multiple meetings and verbal feedback has been very positive.
Year(s) Of Engagement Activity 2015,2016,2017,2018
 
Description Presentation - Maternal Sepsis February 2016 (Geneva) 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Policymakers/politicians
Results and Impact In February 2016 the WHO convened a meeting in Geneva with my team: other attendees (arranged subsequently) were representatives of Jhpiego, The UK Sepsis Trust and the Global Sepsis Alliance. We discussed possibilities for future work to develop a sepsis bundle. Building on our work within the AIMS trial to study maternal infection, we began to prepare a new research plan to find out how a package of simple, reproducible interventions applied consistently in low income settings could identify and treat maternal sepsis more promptly and effectively.
Year(s) Of Engagement Activity 2016
 
Description Presentation at World Sepsis Congress Spotlight: Maternal and Neonatal Sepsis, 2017 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Presentation on Maternal Sepsis and innovations to improve diagnosis and treatment of maternal sepsis in low resource settings
Year(s) Of Engagement Activity 2017
URL https://www.wscspotlight.org/
 
Description Presentation to GVS - AIMS 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact 40 members of the Gynaecological Visiting Society attended a talk and watched a video about the AIMS project.

Conference delegates were moved by reports of the conditions of maternal healthcare in low income countries, and commented on the importance of projects such as AIMS.
Year(s) Of Engagement Activity 2014
 
Description Presentation to the Department of Obstetrics and Gynaecology, and Society of Obstetrics and Gynaecology, Pakistan (SOGP) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact I presented a lecture entitled "Recurrent Miscarriage and Sepsis in Obstetrics and Gynaecology" whilst visiting Aga Khan University.
Year(s) Of Engagement Activity 2017
 
Description Public Health Priorities in low resource settings 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Undergraduate students
Results and Impact This was a lecture to medical students at Busitema University Medical School.
Year(s) Of Engagement Activity 2017
 
Description Research Taster Session for undergraduate students - 2 groups 
Form Of Engagement Activity Participation in an open day or visit at my research institution
Part Of Official Scheme? Yes
Geographic Reach Local
Primary Audience Undergraduate students
Results and Impact Provided an opportunity for undergraduate students to consider involvement in research and how this may fit into their future career. Also provide a taster into the life of a young researcher and the realities of engaging in medical research. Prompted much discussion and interest, managed to enthuse some of the participants who hope to engage further.

3 of the students will return to the lab for summer work experience
Year(s) Of Engagement Activity 2014,2015
 
Description Sabbatical Activities - AIMS 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Study participants or study members
Results and Impact During 2015 I spent three months in Africa: this sabbatical period enabled me to visit AIMS locations to build new connections and renew old friendships with a view to ongoing research collaborations.
Year(s) Of Engagement Activity 2015
 
Description Soda and Snacks - AIMS 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact All relevant practitioners at AIMS hospitals and referral centres were periodically invited to discuss the trial informally over "soda and snacks."
Year(s) Of Engagement Activity 2015,2016,2017
 
Description Think Corner 2014 - AIMS 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact On Wednesday 27 August 2014 the AIMS trial participated in the Think Corner, a public engagement pop-up shop in the city centre for the University of Birmingham. We explained the necessity and importance of clinical trials, and asked the children of Birmingham what they thought of research.

Children told us that research is important because...
... it helps to understand the world we live in, how we live in it and make new discoveries that enable us to develop new technologies that improve our lives.
... it's fun.
... we learn new things and develop our world.
Year(s) Of Engagement Activity 2014
URL http://www.birmingham.ac.uk/news/latest/2014/08/pop-up-shop-20-08-14.aspx
 
Description Tommys misCOURAGE campaign 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Patients, carers and/or patient groups
Results and Impact Despite one in four pregnancies ending in miscarriage, the silence around the subject means that many couples who have lost babies harbour unexpressed feelings of failure, isolation and guilt. This campaign seeks to tell the stories of all those who have experienced miscarriage.
Year(s) Of Engagement Activity 2015,2016,2017,2018
URL https://www.tommys.org/miscourage
 
Description Twitter - AIMS 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Supporters
Results and Impact Regular tweets keep the AIMS community abreast of project progress and signpost supporters to topical resources in the field of global women's health. This engagement builds the morale of participants and staff, and the interest of other stakeholders and donors.

This engagement builds the morale of participants and builds the interest of supporters in the AIMS project.
Year(s) Of Engagement Activity 2013,2014,2015,2016,2017
 
Description Visit to Aga Khan University and other sites in Pakistan to review the progress of the AIMS trial 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact I held a series of site visits and other meetings at Aga Khan University, Pakistan to discuss the ongoing progress of the AIMS trial with healthcare professionals and data managers.
Year(s) Of Engagement Activity 2017
 
Description Visit to Malawi 2016 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Study participants or study members
Results and Impact I visited AIMS sites in Malawi to speak to peer support groups about the impact of miscarriage in early pregnancy and early age pregnancy. I also held discussions about future collaboration opportunities with organisations such as World Sepsis Alliance, Save the Children and WHO.
Year(s) Of Engagement Activity 2016
 
Description Website - AIMS 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact The AIMS study maintains an active website.

Participants, collaborators and supporters of the AIMS Trial and any other interested members of the public are able to verify the details of the project easily at any time.
Year(s) Of Engagement Activity 2014,2015,2016,2017,2018
URL http://www.aimstrial.org
 
Description Wellbeing of Women - Annual Womens Lunch Presentation 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact Raised the profile and importance of research on understanding the aetiology of pregnancy loss and complications. Resulted in significant interest from women in attendance and discussion regarding novel treatments for miscarriage and the role of clinical trials in this patient group.

Received letter of thanks from WOW charity explaining they had had excellent feedback from attendees and good response to their fundraising launched there
Year(s) Of Engagement Activity 2015