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AUTOP 2 : Screen-and-treat strategy for vaginal flora abnormalities by molecular biology in pregnant women at high risk of preterm birth: A Multicentre, Randomized Study
EU CTIS ID: 2023-509421-41-03
What this study is testing
Evaluate the effectiveness of an innovative screen-and-treat strategy for vaginal flora abnormalities by molecular biology using POC multiplex technology before 18 weeks’ gestation to reduce the rate of preterm birth in a population of pregnant women at high risk of preterm birth (with previous history of preterm birth or late fetal loss), in comparison with a usual strategy with absence of screening.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Pregnant women 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 Affiliated to a social security regimen or equivalent
You likely can't join if
- Woman of legal age under legal protection
- Woman presenting contraindications to the study treatments, in particular hypersensitivity to the active substance or to any of the excipients.
- Ectopic pregnancy
- Non-evolutive pregnancy or intrauterine fetal demise/death leading to preterm birth without other preterm birth
- Woman with only history of preterm birth because of preeclampsia or intrauterine growth restriction but without a history of preterm birth before 37 weeks of gestation or late miscarriage (high-risk preterm birth population between 14 and 22 weeks of gestation)
- Woman with history of preterm birth or voluntary fetal abortion or fetal abortion for medical indication but without a history of preterm birth before 37 weeks of gestation or late miscarriage (high-risk preterm birth population between 14 and 22 weeks of gestation).
See the full eligibility criteria
- Pregnant women 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 Affiliated to a social security regimen or equivalent
- Woman of legal age under legal protection
- Woman presenting contraindications to the study treatments, in particular hypersensitivity to the active substance or to any of the excipients.
- Ectopic pregnancy
- Non-evolutive pregnancy or intrauterine fetal demise/death leading to preterm birth without other preterm birth
- Woman with only history of preterm birth because of preeclampsia or intrauterine growth restriction but without a history of preterm birth before 37 weeks of gestation or late miscarriage (high-risk preterm birth population between 14 and 22 weeks of gestation)
- Woman with history of preterm birth or voluntary fetal abortion or fetal abortion for medical indication but without a history of preterm birth before 37 weeks of gestation or late miscarriage (high-risk preterm birth population between 14 and 22 weeks of gestation).
- Woman for who the history of preterm birth before 37 weeks of gestation or late miscarriage history is due to intra uterine demise before labor or voluntary abortion
- Adult patient under guardianship or trusteeship, patient deprived of liberty
- Nulliparous
- Multiple pregnancy (twins, triplet or more)
- Serious fetal malformation identified at first trimester screening such as cardiopathy, exencephaly, anasarque, gastroschisis, omphalocele, and diaphragmatic hernia, cerebral or spinal major anomaly.
- Woman presenting uterine malformation (unicornuate, bicornuate, full septate)
- Woman with preterm birth history because of twin pregnancy
- Woman participating in any clinical trial or intent to participate in another clinical trial, which may have an impact on flora or on prematurity rate, with or without investigational product at any time during the conduct of this study
- Woman having received anti-infective treatment in the week preceding inclusion
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.