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A Combination of Antibiotics to Decrease Neonatal Morbidity and Mortality for Previable Threatened Labor

NCT06572761 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2026-05-01

No results posted yet for this study

Summary

The purpose of this study is to determine whether a combination of antibiotics (cephalosporin 3rd generation, clarithromycin, metronidazole) are effective to prolong pregnancies complicated with previable threatened labour with intact membranes.

Conditions

  • Previable Labour With Intact Membranes

Interventions

DRUG

Combination of antibiotics

Ceftriaxone : 1g/day parenteral clarithromycin 500 mg\*2/day orally metronidazole 500mg\*3/ day orally

DEVICE

Emergency cerclage

Emergency cerclage

DRUG

Vaginal progesterone

Vaginal progesterone

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Thibaud QUIBEL, MD, PhD · Centre Hospitalier Poissy-Saint Germain

  • Jean BOUYER · Institut National de la Santé Et de la Recherche Médicale, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2030-05-31
Completion
2030-05-31

Countries

  • France

Study Locations

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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 NCT06572761 on ClinicalTrials.gov