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New treatment option for Preterm Premature Rupture of Membranes (PPROM)
Official title TAILORED Therapeutic Regime in Patients With Preterm Premature Rupture Of Membranes to Prolong Pregnancy, Improve Maternal and Neonatal Outcomes, and Reduce Antibiotic Burden
ClinicalTrials.gov ID: NCT07107477
What this study is testing
What is Antenatal steroids administration?
Antenatal steroids administration is an investigational medicine, given as an once-weekly, being studied as a potential treatment for preterm premature rupture of membranes (pprom).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- pPPROM Confirmed by Amnisure test1 and/or clinical signs of pPROM on examination (Clinical signs of pPROM: presence of visual pooling of amniotic...
- Weeks of pregnancy 22+03 - 33+64
- Singleton pregnancy
- Signed informed consent form (ICF)
- Completely uncomplicated pregnancy until the occurrence of pPROM
You likely can't join if
- 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)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Brno, Czechia
- Prague, Czechia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brno, Czechia; Prague, Czechia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.