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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThe Central and Eastern European Gynecologic Oncology Group

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • 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

Treatment groups

138 Participants
are divided into 2 treatment groups

Sponsors and collaborators

The Central and Eastern European Gynecologic Oncology Group

Lead sponsor

General University Hospital, Prague

Sponsor institution

Brno University Hospital

Collaborator

General University Hospital, Prague

Collaborator