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Study identifier: NCT07366359 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Premature Rupture of Fetal Membranes · Labor, Induced · Cervical Ripening  ·  Sponsor: National Hospital of Obstetrics and Gynecology

PhaseNA
Planned participants450
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 be provided at the National Hospital of Obstetrics and Gynecology in Hanoi, Vietnam, where both medicines are already used in routine practice. The main outcome is how many women have a vaginal birth. The study will also look at how long it takes from induction to birth, complications for mothers and babies, and women's experiences of labor. The results may help doctors choose the safest and most effective way to induce labor for women with term PROM in the future.

This description comes directly from the study's public registry record.

Talk to the study team

Khuyen T.H Truong, MD  ·  +84983851754  ·  khuyenth.hmu@gmail.com

Anh T Ngo, MD, PhD  ·  +84931686600  ·  dr.anhngo@nhog.vn

Always discuss trial participation with your own doctor first.

Locations (1)

National Hospital of Obstetrics and GynecologyHanoi, Hanoi, VietnamRecruiting

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Source record: clinicaltrials.gov/study/NCT07366359