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PGE2 Followed by Oxytocin vs Oxytocin in Term PROM (POXY-PROM)

RecruitingNAAges 18 Years - anyFemaleNational Hospital of Obstetrics and Gynecology
NCT07366359 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study is being done to learn more about the best way to start labor for pregnant women whose water breaks at term before labor begins, a condition called term prelabor rupture of membranes (term PROM). When this happens and the cervix is not ready for labor, it is unclear which induction method works best and is safest for mother and baby. The purpose of this study is to compare two common ways to induce labor in women with term PROM and an unfavorable cervix (Bishop score ≤ 6). One group will receive a vaginal dinoprostone insert (Propess) for 6 hours to soften the cervix, followed by oxytocin if labor does not start. The other group will receive immediate oxytocin through a vein. Pregnant women aged 18 years or older with a single baby in head-down position at 37-42 weeks, whose water has broken and whose cervix is not yet favorable, may be able to join this study. All care will

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📋 Eligibility rules (as published)
Inclusion Criteria * Maternal age ≥ 18 years * Gestational age from 37 to 42 weeks, determined by last menstrual period or by a first- or second-trimester ultrasound * Live singleton fetus * Prelabor rupture of membranes (PROM) confirmed by at least one of the following: * Amniotic fluid visibly draining from the cervical os during sterile speculum examination * Pool of fluid in the posterior fornix * Cephalic presentation * Bishop score ≤ 6 * No spontaneous uterine contractions * No contraindications for vaginal delivery Exclusion Criteria: * Active labor * Previous uterine surgery (e.g., cesarean section) * Chorioamnionitis or non-reassuring fetal status * Major fetal anomalies * Contraindications to prostaglandin or vaginal delivery * Refusal to participate
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What it tests

  • Sequential Induction: Dinoprostone Followed by Oxytocin
  • Immediate Oxytocin Induction
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Where

1 site
National Hospital of Obstetrics and Gynecology
Hanoi, Vietnam
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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