Authorised Therapeutic confirmatory (Phase III) Pregnant patients diagnosed with premature rupture of membranes (PROM)

PeRinatal Outcomes with ACTive versus expectant management of women with Pre-labor Rupture Of Membranes: a phase III, open-label, randomized controlled multicentric trial

EU CTIS ID: 2024-517504-11-00

What this study is testing

The first objective of this study is to evaluate whether active management of women with PROM (early induction) reduces the newborn need of respiratory support.

  • 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

  •  Gestational age ≥ 37 weeks  Negative rectovaginal GBS swab  Absent/poor uterine contractile activity 6 h after PROM (0-2 contractions /10 min)  Cephalic presentation  Age ≥18 years of age at the time of randomization  Ability to provide an informed consent  Signed informed consent

You likely can't join if

  •  Prematurity (<37 weeks)  GBS positive vagino-rectal swab or with an unknown swab  Multiple pregnancies  Previous cesarean section (CS)  Breech presentation, transverse lie or other indication for elective CS  Suspected clinic for intra-amniotic infection (According to the Triple I criteria)  Stained amniotic fluid  Alterations of the FHR  Unknown exact ROM time  Known hypersensitivity to drugs for IOL or their excipients  Presence of unknown vaginal bleeding  Presence of maternal kidney disease (GFR <15 ml/min/1,73 m2).  Every condition contraindicating vaginal delivery

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, 18-64 years. The study team makes the final eligibility decision.

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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.