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TAILORED-PROM: Personalized therapeutic approach for preterm premature rupture of membranes to safely prolong pregnancy, enhance maternal and neonatal outcomes, and minimize unnecessary antibiotic use.
EU CTIS ID: 2024-520237-77-00
What this study is testing
The objective of the trial is to evaluate if tailored antibiotic and steroid therapy based on the IL-6 value in amniotic fluid obtained by amniocentesis in patients with premature rupture of membranes is associated with pregnancy prolongation compared to standard treatment.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- age ≥ 18 years
- pPPROM Confirmed by Amnisure test and/or clinical signs of pPROM on examination
- Weeks of pregnancy 22+0 – 33+6
- Singleton pregnancy
- Signed informed consent form (ICF)
- Completely uncomplicated pregnancy util the occurrence of pPROM
You likely can't join if
- Active labour (uterine activity leading to cervical dilatation greater than 4 cm)
- Any contraindication according to the valid SmPC for the administered product
- 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).
See the full eligibility criteria
- age ≥ 18 years
- pPPROM Confirmed by Amnisure test and/or clinical signs of pPROM on examination
- Weeks of pregnancy 22+0 – 33+6
- Singleton pregnancy
- Signed informed consent form (ICF)
- Completely uncomplicated pregnancy util the occurrence of pPROM
- Active labour (uterine activity leading to cervical dilatation greater than 4 cm)
- Any contraindication according to the valid SmPC for the administered product
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, in utero, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.