Tailored IL-6–guided antibiotic and steroid treatment to delay birth after PPROM

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.

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
• Enrollment: 138 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: The Central and Eastern European Gynecologic Oncology Group (Academic / other)
• Locations: 2 sites (Brno and 1 other locations)
• Trial ID: NCT07107477 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Brno and 1 other locations

• University Hospital Brno — Brno, Czechia (Not_yet_recruiting)
• General University Hospital in Prague — Prague, Czechia (Recruiting)

Study contacts

• Study coordinator: Katerina Mackova, MD, PhD, PhD

Conditions Preterm Premature Rupture of Membranes