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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

NCT06349122 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1794

Last updated 2026-08-03

No results posted yet for this study

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

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 .

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2029-06-30
Completion
2029-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06349122 on ClinicalTrials.gov