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TAILORED Therapeutic Regime in Patients With Preterm Premature Rupture Of Membranes to Prolong Pregnancy, Improve Maternal and Neonatal Outcomes, and Reduce Antibiotic Burden

RecruitingPhase 3Ages 18 Years - anyFemaleThe Central and Eastern European Gynecologic Onco…
NCT07107477 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 sc

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📋 Eligibility rules (as published)
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
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What it tests

  • 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
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Where

3 sites
University Hospital Brno
Brno, Czechia
General University Hospital in Prague
Prague, Czechia
Institute for Mother and Child Care in Prague - Podolí
Prague, Czechia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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