TAILORED Therapeutic Regime in Patients With Preterm Premature Rupture Of Membranes to Prolong Pr… (NCT07107477) | Clinical Trial Compass
RecruitingPhase 3
TAILORED Therapeutic Regime in Patients With Preterm Premature Rupture Of Membranes to Prolong Pregnancy, Improve Maternal and Neonatal Outcomes, and Reduce Antibiotic Burden
Czechia138 participantsStarted 2025-05-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The latency of pregnancy of more than 7 days from premature rupture of membranes to delivery
Timeframe: From enrollment to the delivery (0-98 days).
Trial details
NCT IDNCT07107477
SponsorThe Central and Eastern European Gynecologic Oncology Group