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

NCT06349122 | Not Yet Recruiting Phase 3

• 1 other identifier: 2023-509421-41-03
• Study Type: interventional
• Target: 1,794
• Locations: 0 countries
• Sites: N/A

Brief 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%.

Conditions

Bacterial Vaginosis; Vaginal Dysbiosis; Premature Delivery

Keywords

screen and treat strategy

Outcome Measures

Primary Outcomes (1)

• The rate of preterm birth

  The primary endpoint will be the rate of preterm birth before 37 weeks of gestation, which will be compared between the innovative group (Group A experimental) and the standard group (Group B Usual care).

  From the enrollment to the delivery

Study Arms (2)

Group A: Screen-and-Treat Strategy

EXPERIMENTAL

Patients systematically screened for BV before 18 weeks' gestation by means of a vaginal swab analyzed by the innovative technique by PCR, whose result will be disclosed. If positive, appropriate treatment will be prescribed.

Diagnostic Test: Vaginal flora abnormalities screening and quantification using molecular biology technique; Drug: Azithromycin; Drug: Ceftriaxone; Drug: Metronidazole; Drug: Clotrimazole; Drug: Doxycyclin

Group B: Control Group/Usual Care or Standard Strategy

NO INTERVENTION

Usual care group with no screening with multiplex molecular biology. Women will be screened for BV with conventional tools (pH, Amsel or Nugent score) as recommended by ANAES. Woman under 25 years old or/and at risk of sexual transmitted infection: screening for Chlamydia trachomatis will be done as recommended by HAS.

Interventions

Vaginal flora abnormalities screening and quantification using molecular biology technique DIAGNOSTIC_TEST

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.

Group A: Screen-and-Treat Strategy

Ceftriaxone DRUG

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

Group A: Screen-and-Treat Strategy

Metronidazole DRUG

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 .

Group A: Screen-and-Treat Strategy

Azithromycin DRUG

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

Group A: Screen-and-Treat Strategy

Clotrimazole DRUG

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

Group A: Screen-and-Treat Strategy

Doxycyclin DRUG

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

Group A: Screen-and-Treat Strategy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women at high risk of preterm birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

MeSH Terms

Conditions

Vaginosis, Bacterial; Premature Birth

Interventions

Azithromycin; Ceftriaxone; Metronidazole; Clotrimazole; Doxycycline

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Assistance Publique - Hôpitaux de Marseille (AP-HM)

CONTACT

+33491381511; promotion.interne@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: April 5, 2024
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: August 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share