Overview

TAILORED Therapeutic Regime in Patients With Preterm Premature Rupture Of Membranes to Prolong Pregnancy, Improve Maternal and Neonatal Outcomes, and Reduce Antibiotic Burden

Status:
RECRUITING

Trial end date:
2028-05-01

Target enrollment:

Participant gender:

Summary

The goal of this clinical trial is to learn whether tailoring antibiotic and steroid treatment based on a lab result (interleukin-6, or IL-6) from amniotic fluid can help safely prolong pregnancy in people with preterm premature rupture of membranes (pPROM). This condition means the water breaks too early, before 37 weeks of pregnancy, which increases the risk of infection and early birth. The main questions the study aims to answer are: 1. Can using IL-6 levels to guide treatment help the pregnancy last more than 7 days after pPROM? 2. Can this approach improve health outcomes for both the parent and the baby? Researchers will compare two groups: 1. A tailored treatment group, where IL-6 levels from amniotic fluid help decide when to give steroids and antibiotics. 2. A standard care group, where everyone receives the same treatment right after diagnosis. Participants will: * Be screened to confirm pPROM and eligibility. * Be randomly assigned to one of the two groups. * Receive regular check-ups and monitoring in the hospital until delivery. * In the tailored group, have weekly amniocentesis (a safe procedure to collect amniotic fluid) if needed. The study includes follow-up for 6 months after birth to track both the baby's and parent's health. This research may help doctors better time treatments, reduce unnecessary use of medications, and improve outcomes for families facing pPROM.

Phase:

PHASE3

Details

Lead Sponsor:

The Central and Eastern European Gynecologic Oncology Group

Collaborators:

General University Hospital, Prague
University Hospital Brno

Treatments:

Amniocentesis
Antibiotic Prophylaxis
Neuroprotection