TOCOPROM - Tocolysis in the management of preterm premature rupture of membranes before 34 weeks of gestation: a double-blinded randomized controlled trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512872-36-00

Acronym

P160917

Enrollment

850

Registered

2024-07-25

Start date

2024-07-25

Completion date

Unknown

Last updated

2025-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obstetric_pathological delivery

Brief summary

The primary endpoint is a composite outcome including fetal death, neonatal death up to discharge from hospital and/or neonatal severe morbidity.

Detailed description

Prolongation of gestation - Maternal morbidity - Neonatal minor morbidity - Outcomes at 2 years of corrected age

Interventions

DRUGPlacebo of Nifedipine

DRUGNIFEDIPINE

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
The primary endpoint is a composite outcome including fetal death, neonatal death up to discharge from hospital and/or neonatal severe morbidity.	—

Secondary

Measure	Time frame
Prolongation of gestation - Maternal morbidity - Neonatal minor morbidity - Outcomes at 2 years of corrected age	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026