Does progesterone prophylaxis to prevent preterm labour improve outcome? (OPPTIMUM)

Lead Research Organisation: University of Edinburgh
Department Name: School of Clinical Sciences

Abstract

Preterm delivery is the biggest single cause of death and disability amongst babies born in the UK. At present, no drug treatment has been demonstrated to improve the outcome for babies by preventing the onset of preterm labour. It has recently been shown that a natural hormone called progesterone may reduce the risk of preterm delivery by around 50%. In the proposed study, we will confirm or refute this effect on preterm delivery and more importantly determine whether it improves the outcome for the baby and child. Pregnant women at high risk of preterm delivery who agree to take part will be given either a progesterone or a placebo (dummy) pessary daily from 22-24 until 34 weeks of pregnancy. We will record when the woman gives birth, whether the baby survives, and if so its immediate health (including any brain damage or lung disease) and health at two years of age using a developmental assessment scale. We will also calculate the costs of NHS treatment. We hope to show that progesterone treatment reduces the risk of preterm birth, that it improves baby’s immediate health, it is associated with improved thinking ability of the child at two years, and it reduces NHS costs overall.

Technical Summary

Background:
Preterm delivery is the single biggest cause of perinatal mortality and morbidity, accounting for 75% of neonatal deaths. Two recent studies (da Fonseca et al. 2003; Meis, et al. 2003) and four meta-analyses (Sanchez-Ramos et al. 2005; Dodd, et al. 2005; Mackenzie et al 2006, Coomaraswamy et al 2006) have suggested that progesterone prevents preterm delivery in high risk women with singleton pregnancy. However, none of the meta-analyses demonstrated a convincing effect on perinatal mortality or morbidity and no studies have examined the important longer-term neurodevelopmental outcomes. We therefore concur with the conclusions of most of the meta-analyses and editorials that the routine use of progestational agents cannot be justified without evidence of improved outcomes for babies.

Rationale for trial:
The proposed trial will quantify the magnitude of the obstetric, neonatal and child health benefits of vaginal progesterone treatment and evaluate the cost effectiveness of treatment.

Design of trial in high-risk women:
Women will be recruited if there is an appropriate history or a short (less than 25 mm) cervix on ultrasound scan and a positive fetal fibronectin (fFN). Women will be randomised to receive either vaginal progesterone 200mg, or placebo, from 22 weeks gestation daily until 34 weeks gestation. The primary obstetric outcome is delivery before 34 weeks of gestation. The primary neonatal outcome is a composite of death and major morbidity. The primary childhood outcome is neurodevelopmental performance at 2 years of age (Bayley 2006). A formal economic evaluation is a key part of this study.

Implications for practice:
The results will be used to inform policy and practice by determining the clinical and cost effectiveness of progesterone for obstetric, neonatal and childhood outcomes in women at high risk of preterm birth. We will use an inexpensive generic formulation of natural progesterone so the results can be immediately translated into improved patient care if progesterone administration is indicated.

Expertise and personnel:
The applicants include obstetricians and neonatologists (with expertise in both preterm labour and in conducting clinical trials), statisticians, clinical triallists, a health economist, an expert on ascertaining consumer views. We have benefited from advice from lay collaborators. Thirty centres in the UK, with a combined annual delivery rate of 140,000 births have agreed to participate in this trial.

Publications

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Achana F (2018) Authors' reply re: Peripartum hysterectomy: an economic analysis of direct healthcare costs using routinely collected data. in BJOG : an international journal of obstetrics and gynaecology

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Achana FA (2018) Peripartum hysterectomy: an economic analysis of direct healthcare costs using routinely collected data. in BJOG : an international journal of obstetrics and gynaecology

 
Description A pragmatic adaptive sequential placebo controlled randomised trial to determine the effectiveness of Glycerin trinitrate for retained placenta (Got-it trial).
Amount £1,712,000 (GBP)
Funding ID HTA/12/29/01 
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start 01/2014 
End 01/2018
 
Description An open randomised trial of the Arabin pessary to prevent preterm birth in twin pregnancy - STOPPIT- 2.
Amount £1,327,029 (GBP)
Funding ID HTA/13/04/22 
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start 11/2014 
End 11/2018
 
Description Centre funding Tommys (charity)
Amount £240,000 (GBP)
Organisation Guy’s & St Thomas’ Charity 
Sector Charity/Non Profit
Country United Kingdom
Start 04/2008 
End 03/2015
 
Description Development gap funding -Screening efficacy of PROKR1 antagonists in the treatment of pre-term labour
Amount £145,000 (GBP)
Organisation MRC-Technology 
Sector Academic/University
Country United Kingdom
Start 03/2009 
End 03/2011
 
Description EME- Does Metformin reduce excess birthweight in offspring of obese pregnant women
Amount £990,000 (GBP)
Funding ID MC_G1002463 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 05/2010 
End 05/2015
 
Description Effectiveness of progesterone to prevent miscarriage in women with early pregnancy bleeding: A randomised placebo-controlled trial (PRISM Trial
Amount £1,756,618 (GBP)
Funding ID HTA/12/167/26 
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start 12/2014 
End 12/2018
 
Description Glibenclamide and metfoRmin versus stAndard Care in gEstational diabeteS (GRACES) - a feasibility open label randomised trial
Amount £217,000 (GBP)
Funding ID CZH/4/1011 
Organisation Chief Scientist Office 
Sector Public
Country United Kingdom
Start 04/2014 
End 04/2016
 
Description Health Services Research Grants - AFFIRM - Does promoting increased awareness of decreased fetal movements reduce stillbirth
Amount £225,000 (GBP)
Funding ID CZH/4/882 
Organisation Chief Scientist Office 
Sector Public
Country United Kingdom
Start 10/2013 
End 10/2017
 
Description Institutional Strategic Award Scheme
Amount £187,514 (GBP)
Organisation Wellcome Trust 
Sector Charity/Non Profit
Country United Kingdom
Start 07/2012 
End 07/2013
 
Description MRC Centre for Reproductive Health Centre grant
Amount £1,100,000 (GBP)
Funding ID G1002033 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 04/2011 
End 04/2016
 
Description MRC Confidence in Concept - Microfluidic concentration of circulating foetal nucleic acids from maternal blood
Amount £51,585 (GBP)
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 07/2013 
End 07/2014
 
Description MRC Programme Grant - Poly(A)-binding proteins highlight the importance of regulated mRNA translation and stability in determining a functional materno-fetal interface.
Amount £1,494,000 (GBP)
Funding ID MR/J003069/1 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 01/2012 
End 01/2017
 
Description MRC Project Grant - iNKT cells as drivers for preterm labour.
Amount £125,778 (GBP)
Funding ID MR/L002647/1 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 10/2013 
End 04/2015
 
Description March of Dimes - Inherited predisposition to spontaneous preterm birth. 2008-9. March of Dimes
Amount $86,000 (USD)
Organisation March of Dimes Foundation 
Sector Charity/Non Profit
Country United States
Start 01/2008 
End 01/2009
 
Description My baby's movements study. NHMRC (Australia)
Amount $1,364,000 (AUD)
Organisation National Health and Medical Research Council 
Sector Public
Country Australia
Start 01/2014 
End 01/2018
 
Description NIHR global health research group on preterm birth and stillbirth at the University of Edinburgh (the DIPLOMATIC collaboration)
Amount £1,900,000 (GBP)
Organisation University of Edinburgh 
Sector Academic/University
Country United Kingdom
Start 04/2018 
End 03/2021
 
Description Should we treat iron deficiency anaemia of pregnancy with lactoferrin? A randomised controlled trial.
Amount $2,050,000 (AUD)
Organisation National Health and Medical Research Council 
Sector Public
Country Australia
Start 01/2014 
End 01/2018
 
Description Suture Type for Incompetent Cervix and effect on Health outcomes
Amount £1,090,069 (GBP)
Funding ID HTA/13/04/107 
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start 12/2014 
End 12/2018
 
Description Collaborative group for STOPPIT 2 study 
Organisation King's College London
Department Obstetrics and Gynaecology
Country United Kingdom 
Sector Academic/University 
PI Contribution Leadership of a research team for a grant to test a device to prevent preterm labour in twins.
Collaborator Contribution Members of a research team for a grant to test a device to prevent preterm labour in twins.
Impact Grant application not yet funded. Multidisciplinary: obstetrics statistics
Start Year 2012
 
Description Collaborative group for STOPPIT 2 study 
Organisation Newcastle University
Department Department of Obstetrics and Gynaecology
Country United Kingdom 
Sector Academic/University 
PI Contribution Leadership of a research team for a grant to test a device to prevent preterm labour in twins.
Collaborator Contribution Members of a research team for a grant to test a device to prevent preterm labour in twins.
Impact Grant application not yet funded. Multidisciplinary: obstetrics statistics
Start Year 2012
 
Description Collaborative group for STOPPIT 2 study 
Organisation University of Aberdeen
Department Centre for Healthcare Randomised Trials
Country United Kingdom 
Sector Academic/University 
PI Contribution Leadership of a research team for a grant to test a device to prevent preterm labour in twins.
Collaborator Contribution Members of a research team for a grant to test a device to prevent preterm labour in twins.
Impact Grant application not yet funded. Multidisciplinary: obstetrics statistics
Start Year 2012
 
Description Collaborative group for STOPPIT 2 study 
Organisation University of Birmingham
Department Obstetrics and Gynaecology Research
Country United Kingdom 
Sector Academic/University 
PI Contribution Leadership of a research team for a grant to test a device to prevent preterm labour in twins.
Collaborator Contribution Members of a research team for a grant to test a device to prevent preterm labour in twins.
Impact Grant application not yet funded. Multidisciplinary: obstetrics statistics
Start Year 2012
 
Description Collaborative group for STOPPIT 2 study 
Organisation University of Exeter
Department Obstetrics & Gynaecology
Country United Kingdom 
Sector Academic/University 
PI Contribution Leadership of a research team for a grant to test a device to prevent preterm labour in twins.
Collaborator Contribution Members of a research team for a grant to test a device to prevent preterm labour in twins.
Impact Grant application not yet funded. Multidisciplinary: obstetrics statistics
Start Year 2012
 
Description EPPPIC Collaboration 
Organisation Patient-Centered Outcomes Research Institute
Country United States 
Sector Charity/Non Profit 
PI Contribution This was a collaboration stimulated by the publication of the OPTIMUM study, which contradicted some of the existing literature on progesterone prophylaxis to prevent preterm birth. The collaboration aims to perform an IPD of the world literature on progesterone to prevent preterm birth. The collaboration has been commissioned and funded by PCORI (the Patient Centered Research Initiative, USA). University of York are performing the IPD. I lobbied March of Dimes to set up this IPD, March of Dimes then lobbied PCORI who subsequently funded the project.
Collaborator Contribution March of Dimes then lobbied PCORI who subsequently commissioned and funded the project.
Impact A protocol to do an IPD. Disciplines include statistics, patient perspectives as well as pregnancy research.
Start Year 2016
 
Description EPPPIC Collaboration 
Organisation University of York
Department Department of Chemistry
Country United Kingdom 
Sector Academic/University 
PI Contribution This was a collaboration stimulated by the publication of the OPTIMUM study, which contradicted some of the existing literature on progesterone prophylaxis to prevent preterm birth. The collaboration aims to perform an IPD of the world literature on progesterone to prevent preterm birth. The collaboration has been commissioned and funded by PCORI (the Patient Centered Research Initiative, USA). University of York are performing the IPD. I lobbied March of Dimes to set up this IPD, March of Dimes then lobbied PCORI who subsequently funded the project.
Collaborator Contribution March of Dimes then lobbied PCORI who subsequently commissioned and funded the project.
Impact A protocol to do an IPD. Disciplines include statistics, patient perspectives as well as pregnancy research.
Start Year 2016
 
Description FIGO/March of Dimes collaboration 
Organisation International Federation of Gynecology and Obstetrics (FIGO)
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Intellectual contribution to questions on preterm birth causes and analysis of data
Collaborator Contribution Intellectual contribution to questions on preterm birth causes and analysis of data Funding of contract research organisation
Impact None yet
Start Year 2014
 
Description FIGO/March of Dimes collaboration 
Organisation March of Dimes Foundation
Country United States 
Sector Charity/Non Profit 
PI Contribution Intellectual contribution to questions on preterm birth causes and analysis of data
Collaborator Contribution Intellectual contribution to questions on preterm birth causes and analysis of data Funding of contract research organisation
Impact None yet
Start Year 2014
 
Description Preterm birth clinical study group 
Organisation Royal College of Obstetricians and Gynaecologists (RCOG)
Country United Kingdom 
Sector Academic/University 
PI Contribution CI was a member of the CSG from its inception in 2008 and became Chair in 2010. OPPTIMUM co-grantholder was Chair of the Preterm birth CSG from 2008 onwards and is now a member. Another OPPTIMUM co-grantholder has been a member of the CSG since 2008
Collaborator Contribution The OPPTIMUM grant and the informal collaboration which initiated this grant stimulated the RCOG to set up clinical study groups, with the Preterm Birth Clinical Study group being the exemplar of this. The Preterm Birth CSG has provided a focus for discussion about new trials in preterm birth, and provides some support (largely in terms of a discussion forum) for ongoing trials
Impact Collaboration is somewhat multidisciplinary in that there are paediatric, lay and midwifery members. The collaboration has led to several other grant applications none of which have been successful so far. Another three grant applications have been submitted based on the activity of the preterm birth CSG.
Start Year 2008
 
Description Scottish and Irish collaboration for stillbirth prevention study 
Organisation Norwegian Institute of Public Health
Department Department of International Public Health
Country Norway 
Sector Public 
PI Contribution I initiated this collaboration to generate a proposal and later funding for a stillbirth prevention study
Collaborator Contribution Intellectual input
Impact Multidisciplinary grant application - obstetrics, midwifery, statistics, sociology
Start Year 2011
 
Description Scottish and Irish collaboration for stillbirth prevention study 
Organisation Perinatal Ireland
Country Ireland 
Sector Public 
PI Contribution I initiated this collaboration to generate a proposal and later funding for a stillbirth prevention study
Collaborator Contribution Intellectual input
Impact Multidisciplinary grant application - obstetrics, midwifery, statistics, sociology
Start Year 2011
 
Description Scottish and Irish collaboration for stillbirth prevention study 
Organisation University of Manchester
Department Obstetrics
Country United Kingdom 
Sector Academic/University 
PI Contribution I initiated this collaboration to generate a proposal and later funding for a stillbirth prevention study
Collaborator Contribution Intellectual input
Impact Multidisciplinary grant application - obstetrics, midwifery, statistics, sociology
Start Year 2011
 
Title AFFIRM - Does promoting increased awareness of decreased fetal movements reduce stillbirth, a stepped wedge cluster randomised trial? 
Description Chief Scientist Office, Scottish Executive, (HSRC) and Sands 
Type Diagnostic Tool - Non-Imaging
Current Stage Of Development Early clinical assessment
Year Development Stage Completed 2016
Development Status Under active development/distribution
Clinical Trial? Yes
Impact n/a 
URL http://www.crh.ed.ac.uk/affirm/
 
Title An open randomised trial of the Arabin pessary to prevent preterm birth in twin pregnancy - STOPPIT- 2. 
Description National Institute of Health, Health Technology Assessment Board 
Type Therapeutic Intervention - Drug
Current Stage Of Development Early clinical assessment
Year Development Stage Completed 2016
Development Status Under active development/distribution
Clinical Trial? Yes
Impact n/a 
URL https://w3.abdn.ac.uk/hsru/stoppit2/
 
Title EMPOWaR 
Description Use of metformin to reduce birthweight centile in obese pregnant women. Clinical trial called EMPOWaR funded by NIHR / EME Clinical trial - ISRCTN51279843 
Type Therapeutic Intervention - Drug
Current Stage Of Development Early clinical assessment
Year Development Stage Completed 2010
Development Status Under active development/distribution
Clinical Trial? Yes
UKCRN/ISCTN Identifier ISRCTN51279843
Impact None yet 
URL http://www.controlled-trials.com/ISRCTN51279843
 
Title Glibenclamide and metfoRmin versus stAndard Care in gEstational diabeteS (GRACES) - a feasibility open label randomised trial 
Description Chief Scientist Office, Scottish Executive. 
Type Therapeutic Intervention - Drug
Current Stage Of Development Initial development
Year Development Stage Completed 2016
Development Status Under active development/distribution
Clinical Trial? Yes
Impact n/a 
URL https://www.npeu.ox.ac.uk/graces
 
Description Progesterone does not prevent preterm labour (debate). European Board and College of Obstetrics and Gynaecology meeting Glasgow, May 2014. 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Talk sparked questions and discussion afterwards
Year(s) Of Engagement Activity 2014
 
Description 2. Preterm Labor - Improving Clinical Outcomes Now and in the Future 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact PREBIC symposium, Society of Reproductive Investigation Meeting, San Francisco
Year(s) Of Engagement Activity 2015
 
Description 37th Annual Pregnancy Meeting, Society for Maternal and Fetal Medicine, 23-28 January 2017, Las Vegas, USA 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Invited speaker: talk title: Management of a woman with a previous preterm birth
Year(s) Of Engagement Activity 2017
URL https://www.smfm.org/meetings/2-37th-annual-pregnancy-meeting
 
Description 38th Annual Pregnancy Meeting, Society for Maternal and Fetal Medicine, Dallas, Texas, USA 29 January - 3 February 2018 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Round Table - Preterm Birth: Diagnosis
Year(s) Of Engagement Activity 2018
 
Description 3rd European Spontaneous Preterm Birth Congress, Edinburgh, 16-18 May 2018 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Keynote lecture title: Anti-inflammatory targets for preterm birth
Year(s) Of Engagement Activity 2018
URL https://www.ed.ac.uk/files/atoms/files/final_espbc_program.pdf
 
Description An Odyssey in pregnancy research - there and back again. Inaugural Lecture, University of Edinburgh 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact Around 150 people attended this talk

Increased awareness of issues of maternal obesity
Year(s) Of Engagement Activity 2010
 
Description British Maternal and Fetal Medicine Society 19th Annual Meeting, Amsterdam, The Netherlands, 30-31 March 2017 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Invited speaker - talk title: Progesterone for preterm birth, a complex story
Year(s) Of Engagement Activity 2017
URL https://www.emedevents.com/c/medical-conferences-2017/the-british-maternal-fetal-medicine-society-bf...
 
Description Can we prevent preterm delivery? 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Speaking at international meeting - Peter Dunn Lecture, British Association for Perinatal Medicine, Birmingham
Year(s) Of Engagement Activity 2017
 
Description Centre for Reproductive Biology Public Lecture series 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact 250 attendees to a talk about preterm labour which included discussion of the need for clinical trials such as OPPTIMUM and how they are undertaken.
Significant discussion afterwards.

Some attendees expressed interest in medicine / research as a career
Year(s) Of Engagement Activity 2009
 
Description Diagnosis and pharmacological management of preterm labour and birth 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact FIGO working group on Preterm BirthClinical Health Perspective. Presentation at FIGO (International Federation of Obstetrics and Gynaecology Meeting
Year(s) Of Engagement Activity 2015
 
Description Hormones, the immune system and the initation of parturition. World Congress of Reproductive Biology Meeting, Edinburgh October 2014. 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Qus and discussion
Year(s) Of Engagement Activity 2014
 
Description Improving outcomes for pregnant women and babies in Scotland through research. Scottish Government Maternity Services Good Practice Event Edinburgh, May 2014. 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Talk sparked questions and discussion afterwards

Talk sparked questions and discussion afterward
Year(s) Of Engagement Activity 2014
 
Description Inaugural lecture 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact 120 attendees

Interest in research into preterm birth
Year(s) Of Engagement Activity 2010
 
Description Management of a woman with a previous preterm birth 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Speaking at an international meeting - Society for Maternal and Fetal Medicine, Las Vegas
Year(s) Of Engagement Activity 2017
 
Description Medical Detective Series 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact Audience of 100 members of the public who asked questions about research into preterm birth and its prevention.


The lecture is available on You Tube at http://www.youtube.com/watch?v=TC43j2UJ-GI&feature=player_embedded. As of Nov 2011 it has had 1400 hits on "You tube".
Year(s) Of Engagement Activity 2010
 
Description Pediatric Academic Societies Meeting Baltimore 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Four presentations of preliminary data from EPICure@19 and one from OPPTIMUM. All well received
Year(s) Of Engagement Activity 2016
URL https://www.pas-meeting.org
 
Description Pint of Science Public Engagement Talk 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact Pint of Science Talk "Sex Drugs and Birth" 23.5.16
Year(s) Of Engagement Activity 2016
URL https://pintofscience.co.uk/
 
Description Preterm BirthClinical Health Perspective. 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact FIGO working group on Preterm BirthClinical Health Perspective. Presentation at FIGO (International Federation of Obstetrics and Gynaecology Meeting, Vancouver
Year(s) Of Engagement Activity 2015
 
Description Progesterone for preterm birth, a complex story 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Speaking at international meeting - British Maternal and Fetal Medicine Society, Amsterdam
Year(s) Of Engagement Activity 2017
 
Description Progesterone for prevention of preterm birth. Gaps in current knowledge and long term effects. COGI meeting. Paris, December 2014. 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Talk sparked questions and discussion
Year(s) Of Engagement Activity 2014
 
Description Progesterone, why we should not depend on it to prevent preterm birth 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Speaking at international meeting - PREBIC session at Society for Reproductive Investigation, Orlando, USA
Year(s) Of Engagement Activity 2017
 
Description Prophylactic progesterone in asymptomatic women (PRO). 1st European Spontaneous Preterm Birth Congress and 2nd PREBIC International Satellite Symposium, Svenborg, May 2014. 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Talk sparked questions and discussion
Year(s) Of Engagement Activity 2014
 
Description RCOG World Congress, Singapore, 21-24 March 2018 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Invited speaker - talk title: Is it time to revisit progesterone after the OPPTIMUM trial?
Year(s) Of Engagement Activity 2018
URL http://web.rcog2018.com/client/sites/view/SP4cb78
 
Description Sweden Obstetrics and Gynaecology Society (SFOG) Congress, Uppsala, Sweden, 27-30 August 2018 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Invited speaker - title of talk: Preterm birth - if progesterone is not the answer, what is?
Year(s) Of Engagement Activity 2018
URL http://www.coursefordoctors.com/cfdevents/details?id=12505
 
Description Therapy to stop premature birth safe but ineffective, study finds 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact A therapy widely recommended in the UK, Europe and the US to stop babies from being born too soon is ineffective, research shows.
The treatment does not appear to pose any harm to mother or baby but has no effect on preventing an early birth, the findings reveal.
Researchers say that use of the medicine should be reviewed. They also call for a re-doubling of efforts to find alternative interventions to prevent premature births.
Previous research suggested that the therapy - a hormone called progesterone - may stop pregnant women from giving birth early but little was known about its long term effects.
This latest trial - involving more than 1200 women - is the largest to assess the effects of the treatment on women and the first to study its effects in babies born after the therapy.
Researchers focused on women who are considered to have a greater risk of premature delivery - either because they have previously delivered a baby early or have lost a baby late in pregnancy.
Around a half of the women were given progesterone and the others were given a dummy pill.
The team found that whilst the therapy appeared to be safe, it did not reduce the risk of premature delivery and offered no notable health benefits for mother or baby.
More than 64 hospitals from around the UK were involved in the research, which was led by the Tommy's Centre for Maternal and Fetal Health at the University of Edinburgh.
The study is published in The Lancet. It was funded by the Efficacy and Mechanism Evaluation (EME) Programme, a partnership between the Medical Research Council and National Institute for Health Research.
Professor Jane Norman, Director of the Tommy's Centre for Maternal and Fetal Health at the University of Edinburgh, said: "Babies born too early have a much greater risk of short-term and long-term health problems. We need to find new strategies that help mums carry their babies to term."
Year(s) Of Engagement Activity 2016
 
Description What works for prevention and treatment of preterm birth? Evidence from randomised trials 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Speaking at international meeting - GAPPS foundation meeting, London
Year(s) Of Engagement Activity 2017