Prospective Randomized Controlled Trial to Evaluate if Tailored Antibiotic and Steroid Therapy Based on the Interleukin-6 (IL-6) Value in Amniotic Fluid Obtained by Amniocentesis in Patients With Premature Rupture of Membranes is Associated With Pregnancy Prolongation Compared to Standard Management.
| Registry | NCT07107477, acronym TAILORED-PROM |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 138 (Estimated) |
| Sponsor | The Central and Eastern European Gynecologic Oncology Group (Other); collaborators: Brno University Hospital, General University Hospital, Prague |
| Conditions | Preterm Premature Rupture of Membranes (PPROM) |
| Interventions | Tailored antibiotic and steroid therapy based on the IL-6 value in amniotic fluid obtained by amniocentesis in patients with premature rupture of membranes, Antenatal steroids administration, Neuroprotection, antibiotic prophylaxis, Antibiotics administration (Procedure, drug) |
| Dates | start 2025-05-01, primary completion 2027-09-01 (estimated), completion 2028-05-01 (estimated), first posted 2025-08-06, last updated 2026-06-18 |
| Locations | 3 sites in Czechia |
Related Papers Related Patents Related Grants Related Experts
All trials for Preterm Premature Rupture of Membranes (PPROM) All trials of Tailored antibiotic and steroid therapy based on the IL-6 value in amniotic fluid obtained by amniocentesis in patients with premature rupture of membranes All trials of Antenatal steroids administration
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| ARM A: TAilored management | Experimental | Procedure: Tailored antibiotic and steroid therapy based on the IL-6 value in amniotic fluid obtained by amniocentesis in patients with premature rupture of membranes; Drug: Antenatal steroids administration; Drug: Neuroprotection; Drug: antibiotic prophylaxis | No steroids at admission Antibiotics - GBS prophylaxis + macrolides always at admission till results of amniotic fluid IL-6 Amniocentesis (Within 24 hours of admission to the hospital) * Based on the amniotic fluid IL-6 results: * IL-6 ˂ 2600 - discontinuing GBS prophylaxis + macrolides, no steroids. * IL-6 ≥ 2600 - Steroids and initial broad spectrum ABX, adjustment according to cultures and PCR |
| ARM B: standard care | Active comparator | Drug: Antenatal steroids administration; Drug: Neuroprotection; Drug: antibiotic prophylaxis; Drug: Antibiotics administration | Antenatal steroids - always at admission Antibiotics - GBS prophylaxis + macrolides, lasting for 7-10days, then discontinued. |
Sex: Female, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| University Hospital Brno | Brno | Czechia | Recruiting |
| General University Hospital in Prague | Prague | Czechia | Recruiting |
| Institute for Mother and Child Care in Prague - Podolí | Prague | Czechia | Recruiting |