Actively Recruiting
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
Eligibility Criteria
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
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
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
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
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