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

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.

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.

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