AUTOP 2: Screen-and-treat Strategy for Vaginal Flora Abnormalities by Molecular Biology in Pregna… (NCT06349122) | Clinical Trial Compass
Not Yet RecruitingPhase 3
AUTOP 2: Screen-and-treat Strategy for Vaginal Flora Abnormalities by Molecular Biology in Pregnant Women at High Risk of Preterm Birth
1,794 participantsStarted 2026-07
Plain-language summary
Preterm birth is a major cause of mortality and long-term disability. Bacterial vaginosis (BV) is a frequent form of dysbiosis that is often asymptomatic and increases the risk of preterm birth. BV is usually diagnosed using conventional tools such as the Nugent score. Molecular diagnosis of BV has now been shown to be more reproducible and to provide a more accurate characterization of dysbiosis.
The main objective of this study is to evaluate the effectiveness of a self screen and treat strategy for vaginal flora dysbiosis, based on molecular point of care (POC) multiplex technology before 18 weeks' gestation, in reducing the rate of preterm birth among pregnant women at high risk, compared with usual care.
The hypothesis is that a Screen-and-Treat strategy using molecular biology among women with previous preterm or/and an history of late abortion could be effective in reducing preterm births by 40%.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* Pregnant woman over 18 years of age;
* Single intra uterine pregnancy after 8 weeks and before 18 weeks of gestation (i.e. ≥ 8 weeks and ≤ 18 weeks). Woman can present symptomatic vaginal discharge, or can be asymptomatic or symptomatic with regard to the diagnosis of bacterial vaginosis (BV) with usual technics;
* With a history of :
* preterm birth before 37 weeks of gestation (even if the preterm birth was following preterm rupture of membranes);
* and / or late miscarriage or fetal loss (i.e. miscarriage or foetal loss between 14 and 22 weeks of gestation), even if one any of her last birth occurred at term.
* Woman having a reliable connexion by phone
* Woman who has understood the study process and objectives and agreed to sign an informed consent form;
* affiliated to a social security regimen or equivalent.
Any eligible woman who will agree to participate in the study after being invited must sign a consent form before being included in the study. Women meeting all of these eligibility criteria will be invited even if they have oral or vaginal progestative treatment, cerclage or pessary, partially septate or arcuate uterus.
Exclusion Criteria:
* \- Woman of legal age under legal protection;
* Women deprived of their freedom for administrative or legal reasons;
* Woman who has not signed a consent form
* Nulliparous;
* Ectopic pregnancy;
* Non-evolutive pregnancy or IUFD
* Multiple pregnancy
* Serious fetal malformation identified at first trimester screening…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The rate of preterm birth
Timeframe: From the enrollment to the delivery
Trial details
NCT IDNCT06349122
SponsorAssistance Publique Hopitaux De Marseille
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2029-06
Contact for this trial
Assistance Publique - Hôpitaux de Marseille (AP-HM)