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NOT YET RECRUITING
NCT06572761
PHASE3

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Official title: A Combination of Antibiotics to Decrease Neonatal Mortality and Morbidity for Pregnancies Complicated With Previable Labour and Intact Membranes: a Multicenter, Open-label, Randomized and Controlled Trial

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

350

Start Date

2024-09

Completion Date

2028-05

Last Updated

2024-08-27

Healthy Volunteers

No

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

Locations (1)

Centre Hospitalier Poissy-Saint Germain

Poissy, France