Tailored IL-6–guided antibiotic and steroid treatment to delay birth after PPROM
Official title: 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.
Run by The Central and Eastern European Gynecologic Oncology Group · NCT07107477 · Data updated 2026-11-12
This tests whether using an IL-6 lab result from amniotic fluid to guide antibiotics and steroids can help people with PPROM stay pregnant longer and improve outcomes for parent and baby.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 138 (estimated) |
| Sponsor | The Central and Eastern European Gynecologic Oncology Group Academic / other |
| Locations | 3 sites (Brno and 2 other locations) |
| Status | Recruiting |
| Started | May 1, 2025 |
| Main results expected | September 1, 2027 |
| Study ends | May 1, 2028 |
| Registry record updated | June 18, 2026 |
| Trial ID | NCT07107477 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with a singleton pregnancy between about 22+3 and 33+6 weeks with confirmed PPROM, an otherwise uncomplicated pregnancy, and who can consent to amniocentesis and follow-up.
✕Probably not a fit
Patients in active labour, those with obstetric indications for immediate delivery (heavy bleeding, prolapsed cord, or fetal distress), signs of chorioamnionitis, multiple pregnancy, major fetal anomalies, or severe immunosuppression are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this randomized phase 3 trial people with confirmed preterm premature rupture of membranes (PPROM) are assigned to either an IL-6–guided treatment arm or a standard-care arm. The tailored arm uses amniocentesis to measure interleukin-6 (IL-6) in amniotic fluid and uses that value to decide timing of antenatal steroids, antibiotics, and neuroprotection, while the standard arm receives usual treatment immediately. Key outcomes include whether pregnancy is prolonged beyond seven days after PPROM, maternal and neonatal health measures, and overall antibiotic exposure. The approach aims to reduce unnecessary antibiotics while safely delaying delivery when appropriate.
Why it matters
Potential benefit: If effective, this approach could safely extend pregnancy after PPROM, lowering risks of preterm birth complications and reducing unnecessary antibiotic exposure.
How similar studies have gone: Previous research shows IL-6 can indicate intra-amniotic inflammation and predict outcomes, but using IL-6 to guide antibiotic and steroid decisions is relatively novel and not yet widely validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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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
Study contacts
- Study coordinator: Katerina Mackova, MD, PhD, PhD
- Email: katerina.mackova@vfn.cz
- Phone: +420733253563
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Emotional Freedom Technique and Music Therapy in High-Risk Pregnancy for PPROM
This study tests whether emotional freedom techniques and music therapy can help pregnant women with PPROM or PROM cope better and feel less stress.
-
Registry for Preterm Premature Rupture of Membranes
This study is collecting information about pregnancies affected by early water breaking to see what causes it and how to improve care for both moms and babies.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.