Actively Recruiting

Phase 3
Age: 18Years +
FEMALE
NCT07107477

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

Led by The Central and Eastern European Gynecologic Oncology Group · Updated on 2025-08-06

138

Participants Needed

2

Research Sites

156 weeks

Total Duration

On this page

Sponsors

T

The Central and Eastern European Gynecologic Oncology Group

Lead Sponsor

B

Brno University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed preterm premature rupture of membranes (pPROM) by Amnisure test or clinical signs
  • Pregnancy between 22 weeks and 3 days to 33 weeks and 6 days
  • Singleton pregnancy
  • Signed informed consent form
  • Pregnancy without complications until pPROM occurred
Not Eligible

You will not qualify if you...

  • Active labor with cervical dilation over 4 cm
  • Urgent need for delivery due to heavy bleeding, prolapsed cord, or fetal distress
  • Multiple pregnancy
  • Pregnancy with chromosomal or severe physical abnormalities
  • Signs of infection (chorioamnionitis) at admission
  • Severe immune system problems or immunodeficiency
  • Having cancer or receiving immunosuppressive treatment
  • Active drug abuse
  • Non-compliance with study requirements
  • Any contraindications to the study treatments according to product guidelines

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

University Hospital Brno

Brno, Czechia

Not Yet Recruiting

2

General University Hospital in Prague

Prague, Czechia, 128 08

Actively Recruiting

Loading map...

Research Team

K

Katerina Mackova, MD, PhD, PhD

CONTACT

M

Martina Boricnova, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here