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

NCT07366359 | Recruiting DMC

• 1 other identifier: NHOG.2025.POXY-PROM
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Premature Rupture of Fetal Membranes; Labor, Induced; Cervical Ripening

Keywords

Premature Rupture of Fetal Membranes; Labor Induction; Dinoprostone; Oxytocin; Cervical Ripening; Vaginal Delivery

Outcome Measures

Primary Outcomes (1)

• Vaginal delivery

  Number of participants delivered vaginally

  From induction until delivery, assessed up to 36 hours after randomization

Secondary Outcomes (24)

• Mode of delivery

  Within 24 hours from labor induction

• Time from induction of labor to delivery

  From induction until delivery, assessed up to 24 hours after induction

• Oxytocin augmentation

  From induction until delivery, assessed up to 24 hours after induction

• Uterine hyperstimulation

  From induction until delivery, assessed up to 24 hours after induction

• Maternal satisfaction

  Once between 90 minutes and 3 hours after delivery

Other Outcomes (29)

• Vaginal delivery within 12 hours

  From induction until delivery, assessed up to 12 hours after induction

• Reaching active phase of labor

  From induction until reaching active phase, assessed up to 12 hours after induction

• Time from induction to dinoprostone insert removal

  From induction until dinoprostone vaginal insert removal, assessed up to 12 hours after induction

Study Arms (2)

Dinoprostone (Propess) + Oxytocin

EXPERIMENTAL

Participants in this arm will receive a 10-mg vaginal dinoprostone insert (Propess) for cervical ripening. After 6 hours, if active labor has not begun or uterine contractions are inadequate, intravenous oxytocin will be started according to the hospital's standardized induction protocol. Continuous fetal monitoring and standardized management of uterine tachysystole will be applied. This approach reflects a sequential induction method commonly used for women with term PROM and an unfavorable cervix.

Drug: Sequential Induction: Dinoprostone Followed by Oxytocin

Immediate Oxytocin Induction

ACTIVE COMPARATOR

Participants in this arm will receive immediate induction of labor using intravenous oxytocin according to the hospital's standardized induction protocol. No cervical ripening agent will be used before starting oxytocin. Maternal and fetal status will be monitored throughout labor, and uterine tachysystole will be managed in line with institutional guidelines. This arm represents the comparator strategy of inducing labor directly with oxytocin in women with term PROM and an unfavorable cervix.

Drug: Immediate Oxytocin Induction

Interventions

Sequential Induction: Dinoprostone Followed by Oxytocin DRUG

A sequential induction strategy in which a 10-mg vaginal dinoprostone insert (Propess) is placed for cervical ripening. After 6 hours, if active labor has not begun or uterine contractions are inadequate, intravenous oxytocin is initiated according to the hospital's standardized induction protocol. Continuous fetal monitoring is applied, and tachysystole is managed per institutional guidelines.

Also known as: Dinoprostone (Propess)

Dinoprostone (Propess) + Oxytocin

Immediate Oxytocin Induction DRUG

Intravenous oxytocin is used for immediate induction of labor in women with term prelabor rupture of membranes and an unfavorable cervix. Oxytocin is started according to the hospital's standardized induction protocol without prior use of cervical ripening agents. Maternal and fetal status are monitored throughout labor, and uterine tachysystole is managed according to institutional guidelines.

Also known as: Oxytocin

Immediate Oxytocin Induction

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Hospital of Obstetrics and Gynecology: lead

Study Sites (1)

National Hospital of Obstetrics and Gynecology

Hanoi, Hanoi, 100000, Vietnam

RECRUITING

Related Publications (9)

• Prelabor Rupture of Membranes: ACOG Practice Bulletin, Number 217. Obstet Gynecol. 2020 Mar;135(3):e80-e97. doi: 10.1097/AOG.0000000000003700.

  PMID: 32080050 RESULT

• Inducing labour. London: National Institute for Health and Care Excellence (NICE); 2021 Nov 4. Available from http://www.ncbi.nlm.nih.gov/books/NBK579537/

  PMID: 35438865 RESULT

• Kunt C, Kanat-Pektas M, Gungor AN, Kurt RK, Ozat M, Gulerman C, Gungor T, Mollamahmutoglu L. Randomized trial of vaginal prostaglandin E2 versus oxytocin for labor induction in term premature rupture of membranes. Taiwan J Obstet Gynecol. 2010 Mar;49(1):57-61. doi: 10.1016/S1028-4559(10)60010-1.

  PMID: 20466294 RESULT

• Gungorduk K, Asicioglu O, Besimoglu B, Gungorduk OC, Yildirm G, Ark C, Sahbaz A. Labor induction in term premature rupture of membranes: comparison between oxytocin and dinoprostone followed 6 hours later by oxytocin. Am J Obstet Gynecol. 2012 Jan;206(1):60.e1-8. doi: 10.1016/j.ajog.2011.07.035. Epub 2011 Jul 30.

  PMID: 21924396 RESULT

• Gulersen M, Zottola C, Li X, Krantz D, DiSturco M, Bornstein E. Chorioamnionitis after premature rupture of membranes in nulliparas undergoing labor induction: prostaglandin E2 vs. oxytocin. J Perinat Med. 2021 Jun 9;49(9):1058-1063. doi: 10.1515/jpm-2021-0094. Print 2021 Nov 25.

  PMID: 34109770 RESULT

• Mackeen AD, Durie DE, Lin M, Huls CK, Qureshey E, Paglia MJ, Sun H, Sciscione A. Foley Plus Oxytocin Compared With Oxytocin for Induction After Membrane Rupture: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jan;131(1):4-11. doi: 10.1097/AOG.0000000000002374.

  PMID: 29215519 RESULT

• Borovac-Pinheiro A, Inversetti A, Di Simone N, Barnea ER; FIGO Childbirth and Postpartum Hemorrhage Committee. FIGO good practice recommendations for induced or spontaneous labor at term: Prep-for-Labor triage to minimize risks and maximize favorable outcomes. Int J Gynaecol Obstet. 2023 Oct;163 Suppl 2:51-56. doi: 10.1002/ijgo.15114.

  PMID: 37807591 RESULT

• Middleton P, Shepherd E, Flenady V, McBain RD, Crowther CA. Planned early birth versus expectant management (waiting) for prelabour rupture of membranes at term (37 weeks or more). Cochrane Database Syst Rev. 2017 Jan 4;1(1):CD005302. doi: 10.1002/14651858.CD005302.pub3.

  PMID: 28050900 RESULT

• Dos Santos F, Drymiotou S, Antequera Martin A, Mol BW, Gale C, Devane D, Van't Hooft J, Johnson MJ, Hogg M, Thangaratinam S. Development of a core outcome set for trials on induction of labour: an international multistakeholder Delphi study. BJOG. 2018 Dec;125(13):1673-1680. doi: 10.1111/1471-0528.15397. Epub 2018 Sep 10.

  PMID: 29981523 RESULT

Related Links

• Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG). Term prelabour rupture of membranes (Term PROM). RANZCOG guideline \[C-Obs 36\]. Melbourne: RANZCOG; 2021

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Interventions

Dinoprostone; Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Khuyen T.H Truong, MD

CONTACT

+84983851754; khuyenth.hmu@gmail.com

Anh T Ngo, MD, PhD

CONTACT

+84931686600; dr.anhngo@nhog.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel study arms: (1) cervical ripening with a 6-hour vaginal dinoprostone insert (Propess) followed by oxytocin if needed, or (2) immediate induction with intravenous oxytocin. All participants remain in their assigned arm throughout the study; no crossover occurs. Randomization is computer-generated and allocation is concealed. Both interventions reflect routine clinical practice for term PROM with an unfavorable cervix.

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 26, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

VN (1)