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

Recruiting now · Phase 3

Conditions studied: Preterm Premature Rupture of Membranes (PPROM)

In brief

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.

Key facts

Study ID: NCT07107477
Run by: The Central and Eastern European Gynecologic Oncology Group
People needed: 138
Starts: 2025-05-01
Expected to finish: 2028-05-01
Last updated by the study team: 2026-06-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

pPPROM Confirmed by Amnisure test1 and/or clinical signs of pPROM on examination (Clinical signs of pPROM: presence of visual pooling of amniotic fluid during sterile speculum examination)
Weeks of pregnancy 22+03 - 33+64
Singleton pregnancy
Signed informed consent form (ICF)
Completely uncomplicated pregnancy until the occurrence of pPROM

You may not qualify if…

active labour (uterine activity leading to cervical dilatation greater than 4 cm)
Obstetrical reason for immediate delivery such as heavy vaginal bleeding, prolapsed cord, or foetal distress
Multiple pregnancy
Pregnancy with chromosomal or severe morphological abnormality
Signs of chorioamnionitis at the admission (clinical and/or laboratory)
Patients with severe immunological compromise (immunodeficient)
Patients with an oncological disease/immunosuppression
Patients with an active drug abuse
Non-compliant patients
Any contraindication according to the valid SmPC for the administered product

Where it is running

University Hospital Brno — Brno, Czechia (enrolling)
General University Hospital in Prague — Prague, Czechia (enrolling)
Institute for Mother and Child Care in Prague - Podolí — Prague, Czechia (enrolling)

Full record on ClinicalTrials.gov

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