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

Central and Eastern European Gynecologic Oncology Group (CEEGOG)

Status and phase: Enrolling; Phase 3

Conditions: Preterm Premature Rupture of Membranes (PPROM)

Treatments: Drug: Antenatal steroids administration; Drug: antibiotic prophylaxis; Drug: Antibiotics administration; 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: Neuroprotection

Study type: Interventional

Funder types: Other

Identifiers

NCT07107477

TAILORED-PROM 2024-520237-77-0

Details and patient eligibility

About

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.

Enrollment: 138 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 2 patient groups

ARM A: TAilored management

Experimental group

Description:

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

Treatment:

Drug: Neuroprotection

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: antibiotic prophylaxis

Drug: Antenatal steroids administration

ARM B: standard care

Active Comparator group

Description:

Antenatal steroids - always at admission Antibiotics - GBS prophylaxis + macrolides, lasting for 7-10days, then discontinued.

Treatment:

Drug: Neuroprotection

Drug: Antibiotics administration

Drug: antibiotic prophylaxis

Drug: Antenatal steroids administration