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NCT06349122

PHASE3

AUTOP 2: Screen-and-treat Strategy for Vaginal Flora Abnormalities by Molecular Biology in Pregnant Women at High Risk of Preterm Birth

Sponsor: Assistance Publique Hopitaux De Marseille

View on ClinicalTrials.gov

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%.

Official title: Screen-and-treat Strategy for Vaginal Flora Abnormalities by Molecular Biology in Pregnant Women at High Risk of Preterm Birth: A Multicentre, Randomized Study (AUTOP 2)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1794

Start Date

2026-10

Completion Date

2029-06

Last Updated

2026-08-27

Healthy Volunteers

Conditions

Bacterial Vaginosis Vaginal Dysbiosis Premature Delivery

Interventions

DIAGNOSTIC_TEST

Vaginal flora abnormalities screening and quantification using molecular biology technique

Vaginal self-sampling is a simple and validated method of sampling used for the molecular biology technique and the quantification of microorganisms involved in vaginal flora imbalance bacteriosis.The patient performs a self-sampling with a cotton swab transferred into a transport medium tube. The sample is sent to the laboratory where Multiplex Point of Care polymerase chain reaction (PCR) is performed.

DRUG

Azithromycin

In case of Chlamydia trachomatis infections: Azithromycin 1 g per os during the second and third trimester of pregnancy .

DRUG

Ceftriaxone

In case of Neisseria gonorrhoeae infections: Ceftriaxone 1 g IM as a single dose.

DRUG

Metronidazole

In case of Trichomonas vaginalis infections: Metronidazole 500 mg 2 times/day for 7 days, whatever the trimester of pregnancy is . In case of Gardnerella vaginalis infection: Metronidazole 500 mg orally 2 times/day for 7 days . In case of Atopobium/Fannyhessea vaginae and/or Gardnerella vaginalis positivity: Metronidazole 500 mg orally 2 times/day for 7 days .

DRUG

Clotrimazole

In case of Candida albicans infection: 500 mg in a single dose. If necessary, this treatment could be repeated up to 6 times .

DRUG

Doxycyclin

During first trimester of pregnancy ,in case of Chlamydia trachomatis infections at a dose of 200 mg/day 7 days .

* 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 such as cardiopathy, exencephaly, anasarque, gastroschisis, omphalocele, diaphragmatic hernia, cerebral or spinal major anomaly. * 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 presenting contraindications to the study treatments: Hypersensitivity to the active substance or to any of the excipients * Woman presenting uterine malformation ( unicornuate, bicornuate, full septate) * Woman with preterm birth history because of twin pregnancy * Woman having received anti-infective treatment in the week preceding inclusion

Clinical Research Directory

AUTOP 2: Screen-and-treat Strategy for Vaginal Flora Abnormalities by Molecular Biology in Pregnant Women at High Risk of Preterm Birth

Summary

Key Details

Conditions

Interventions

Eligibility Criteria