Is Mycoplasma genitalium in women 'the new chlamydia'' Community based prevalence and prospective cohort study.

Background:
Pelvic inflammatory disease (PID) is infection of the womb and fallopian tubes. It is the most important, preventable, sexually transmitted disease in industrialized countries. PID can be devastating to women?s emotional and physical health as it can lead to infertility, chronic pelvic pain or an ectopic pregnancy in a fallopian tube which can be fatal. Although PID can be caused by chlamydia, in most cases no cause is found.
It is possible that an organism called Mycoplasma genitalium may be a cause or at least a cofactor for PID. We know it is sometimes associated with genitourinary symptoms and it has been found in some women with PID. But we do not know how common it is in normal women, nor whether it can lead to the development of symptoms such as abnormal vaginal discharge, bleeding between periods, pelvic pain and, most important, PID. This means that we do not know if we should be testing women for M.genitalium or if it should be treated.

Aims of the study:
1. To find how common M.genitalium is in young, sexually active, female students in the community.
2. To see if it is commoner in certain groups such as women with more sexual partners or with other infections such as chlamydia or bacterial vaginosis.
3. To investigate the natural history of M.genitalium in women and see if it really does lead to symptoms including PID.

Methods:
The study is unique as it is based in universities and colleges rather than health care settings. It includes 2500 female students, 40% from ethnic minorities, who provided self-taken vaginal swabs for a chlamydia screening trial in 2004-6. Participants are being followed up after 12 months by questionnaire backed by medical record search for development of symptoms including PID. We will test stored vaginal swabs for M.genitalium.

Implications:
The study will provide important new information about M.genitalium. We will find out how common it is in young women, who is more likely to be infected, and whether it can lead to disease. The study uses a relatively new, non-invasive technique of self-taken vaginal swabs; and unlike most studies of M.genitalium is community based. If future research confirms that M.genitalium is an important cause or cofactor for PID, then testing women and treating those who are infected could help to prevent PID, improve women?s reproductive health and wellbeing, and save NHS costs.

Background:
Mycoplasma genitalium is associated with urethritis and cervicitis, but its natural history and role in pelvic inflammatory disease (PID) are unclear. There is a window of opportunity to provide the evidence base before consumers may demand that testing be introduced in the UK. We will use stored self-taken vaginal swabs from our ongoing trial of screening for chlamydia to prevent PID. We will also obtain follow up postal swabs from women with and without M.genitalium at baseline.
Aims:
1. To find the prevalence and predictors of M.genitalium in 2500 young, sexually active female students recruited in the community.
2. To use questionnaires backed by medical records to evaluate the development of symptoms or progression to clinical PID over 12 months in women with and without M.genitalium at baseline (n=2000).
3. To collect follow up postal self-taken vaginal swabs to look at persistence/self-resolution of infection and annual incidence over 1-3 years (n=1000).
4. To explore the role of chlamydia and/or bacterial vaginosis at baseline in the development of M.genitalium associated symptoms or PID over 12 months.
Design:
Combined prevalence and prospective cohort study.
Setting (unique, non-healthcare):
19 London Further Education colleges and universities, mainly inner city.
Participants:
2500 sexually active female students mean age 21 years (30% from black ethnic minorities) who provided self-taken vaginal swabs and completed a questionnaire in 2004-6. They are being followed up by postal, email and telephone questionnaire for incidence of symptoms or clinical PID over 12 months. Follow up: over 85%.
Methods:
Stored samples will be tested for M.genitalium using PCR. All women with M.genitalium at baseline, and all those without M.genitalium who have agreed to return them, will be sent postal follow up swabs. For incidence of clinical PID, possible cases will be identified from responses to 12 month questionnaires backed by clinical records. Confirmation of diagnosis will be done by three physicians blind to results of bacteriological tests.
Main outcome measures:
1. Prevalence and predictors of M.genitalium in 2500 women.
We will look at the relation of M.genitalium with age, ethnicity, age at first sexual intercourse, number of partners, smoking, co-infection with chlamydia or BV; and symptoms at baseline.
2. Development of symptoms or possible PID over 12 months in an estimated 60 women with and 1940 without M.genitalium at baseline.
3. Persistent infection after 1-3 years and annual incidence of infection in 40 women with and 960 without M.genitalium at baseline.