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 (ECHEC-MAT)

NCT06572761 Phase 3 NOT_YET_RECRUITING

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.

Details

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 3
Status	NOT_YET_RECRUITING
Enrolment	350
Start date	2026-09
Completion	2030-05

Conditions

• Previable Labour With Intact Membranes

Interventions

• Combination of antibiotics
• Emergency cerclage
• Vaginal progesterone

Primary outcomes

• A perinatal composite outcome — Up to 24 weeks
  * Late miscarriage * Perinatal mortality * Bronchodysplasia, * Sepsis proven by blood culture, * Intraventricular hemorrhage ≥3, * Periventricular leukomalacia ≥2, * Ulcero-necrotizing enterocolitis at stage ≥2 according to the Bell classification.

Countries

France