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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

Study acronym: AUTOP 2
StatusNot Yet Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 2 months later Mar 2027 → Jun 2029
See other at-risk trials from Assistance Publique Hopitaux De Marseille

Record History

  1. Start date: Jul 2026 to Oct 2026v3
  2. Primary completion pushed from Mar 2027 to Jun 2029 Phase changed: Phase 4 → Phase 3 · Start date: Aug 2024 to Jul 2026 · Enrollment increased: 1292 → 1794 participants · 5 morev2 Show 8 more changesShow less
    • Phase changed: Phase 4 → Phase 3
    • Start date: Aug 2024 to Jul 2026
    • Enrollment increased: 1292 → 1794 participants
    • Completion pushed from Jan 2028 to Jun 2029
    • Interventions: Azithromycine (Drug), Ceftriaxone (Drug), Clotrimazole, Vaginal (Drug), Metronidazole (Drug), Usual Care (Other), Vaginal flora… to Azithromycin (Drug), Ceftriaxone (Drug), Clotrimazole (Drug), Doxycyclin (Drug), Metronidazole (Drug), Vaginal flora abnormalities…
    • Eligibility criteria expanded, about 103 words
    • Study description expanded, about 6 words
    • Study title expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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%.
Trial Details
NCT Number NCT06349122
Lead Sponsor Assistance Publique Hopitaux De Marseille
Conditions Bacterial Vaginosis, Vaginal Dysbiosis, Premature Delivery
Enrollment 1,794 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov