Premature Rupture of Fetal MembranesPOXY-PROMNCT07366359
PGE2 Followed by Oxytocin vs Oxytocin in Term PROM (POXY-PROM)
A study testing Sequential Induction: Dinoprostone Followed by Oxytocin and Immediate Oxytocin Induction in people with Premature Rupture of Fetal Membranes and Labor, Induced, run by National Hospital of Obstetrics and Gynecology at 1 site in Vietnam.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Premature Rupture of Fetal Membranes, Labor, Induced, Cervical Ripening
- What is being tested?
- Sequential Induction: Dinoprostone Followed by Oxytocin and Immediate Oxytocin Induction
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteVietnam
- Study dates
- 10 Feb 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Cephalic presentation
- Bishop score ≤ 6
- No spontaneous uterine contractions
- No contraindications for vaginal delivery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
National Hospital of Obstetrics and Gynecology
Hanoi, Hanoi, 100000
Ha T.T Nguyen, MD, PhD, +84989661093 ext. +84965995599, dr.hanguyen.nhog@gmail.com
Khuyen T.H Truong, MD, +84983851754, truonghakhuyen@hmu.edu.vn
About this study
Official title: Comparison of the Effectiveness of Labor Induction Using Dinoprostone Followed by Oxytocin Versus Oxytocin Alone in Term Pregnancies With Premature Rupture of Membranes and an Unfavorable Cervix - A Randomized Clinical Trial
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.
Read more
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.
Read the detailed description
Prelabor rupture of membranes at term (term PROM) occurs in approximately 8% of pregnancies and is associated with increased risks of maternal infection, neonatal morbidity, and cesarean delivery when labor does not begin promptly. International guidelines recommend active induction of labor for women with term PROM; however, the optimal induction strategy for women presenting with an unfavorable cervix (Bishop score ≤ 6) remains uncertain.
Oxytocin is widely used for induction of labor and is effective when the cervix is favorable, but its efficacy may be reduced in the presence of an unripe cervix. Prostaglandin E2 (dinoprostone) is commonly used for cervical ripening and may improve the likelihood of vaginal delivery when administered prior to oxytocin. Previous randomized trials comparing dinoprostone followed by oxytocin with oxytocin alone have suggested potential benefits, but the available evidence is limited by small sample sizes and inconsistent results. Additional high-quality randomized evidence is therefore required to guide clinical practice in this population.
This randomized controlled trial compares two induction strategies for women with term PROM and an unfavorable cervix: (1) cervical ripening using a 6-hour vaginal dinoprostone (Propess) insert followed by intravenous oxytocin if labor has not commenced, and (2) immediate induction with intravenous oxytocin alone. Both interventions are routinely used in clinical practice in Vietnam and are considered safe.
Participants are randomly assigned in a 1:1 ratio using a computer-generated randomization sequence with variable block sizes of 4 and 6, with allocation concealment ensured through centralized randomization. Randomization is performed after confirmation of eligibility and completion of the informed consent process. Participants remain in their assigned study arm throughout the trial, and no crossover between arms is permitted. All aspects of intrapartum care, including fetal heart rate monitoring, assessment of labor progress, and management of uterine tachysystole or other complications, are conducted according to standard institutional protocols.
The primary outcome of the study is vaginal delivery. Secondary outcomes are selected in accordance with the internationally developed core outcome set for trials on induction of labour and include key maternal, neonatal, and patient-reported outcomes. Maternal outcomes include mode of delivery, time from induction to delivery, need for oxytocin augmentation, uterine hyperstimulation, postpartum hemorrhage, maternal infection, admission to intensive care, hysterectomy, and maternal death. Neonatal outcomes include Apgar scores, admission to the neonatal intensive care unit, neonatal infection, hypoxic-ischemic encephalopathy or need for therapeutic hypothermia, and neonatal death. Patient-reported outcomes, including overall labor pain and maternal satisfaction with the birth process, are also assessed.
A total sample size of 450 participants has been calculated to provide adequate statistical power while accounting for potential attrition. The findings of this study are expected to clarify whether cervical ripening with dinoprostone prior to oxytocin induction improves clinically meaningful outcomes for women with term PROM and an unfavorable cervix, and may help inform future national and international guidelines on induction of labor.
- Being tested
- Sequential Induction: Dinoprostone Followed by Oxytocin, Immediate Oxytocin Induction
- Keywords
- Premature Rupture of Fetal Membranes, Labor Induction, Dinoprostone, Oxytocin, Cervical Ripening, Vaginal Delivery
- Medical subject headings
- Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential Induction: Dinoprostone Followed by OxytocinDrug
Also called Dinoprostone (Propess)
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.
Immediate Oxytocin InductionDrug
Also called Oxytocin
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Immediate Oxytocin Induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal delivery
Number of participants delivered vaginally
Measured: From induction until delivery, assessed up to 36 hours after randomization
Secondary outcomes (24)
Mode of delivery
Number of participants according to mode of delivery, categorized as vaginal delivery, operative vaginal delivery (forceps), or cesarean section
Measured: Within 24 hours from labor induction
Time from induction of labor to delivery
Duration from induction of labor to delivery (hours)
Measured: From induction until delivery, assessed up to 24 hours after induction
Oxytocin augmentation
Number of participants in the intervention group (Group I) who received intravenous oxytocin during the induction process
Measured: From induction until delivery, assessed up to 24 hours after induction
Uterine hyperstimulation
Number of participants who experienced uterine hyperstimulation, defined as more than 5 uterine contractions in 10 minutes over a minimal period of two consecutive 10-minute intervals, and/or a single uterine contraction lasting more than 3 minutes with fetal heart rate changes
Measured: From induction until delivery, assessed up to 24 hours after induction
Maternal satisfaction
Maternal satisfaction, assessed using a 5-point Likert scale, where 1 indicates very dissatisfied and 5 indicates very satisfied
Measured: Once between 90 minutes and 3 hours after delivery
Haemorrhage
Number of participants who experienced postpartum haemorrhage, defined as estimated blood loss greater than 500 mL after vaginal birth or greater than 1000 mL after caesarean birth within 24 hours after delivery
Measured: Within 24 hours from delivery
Uterine rupture
Number of participants with uterine rupture
Measured: From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Hysterectomy for any complications resulting from birth
Number of participants who underwent hysterectomy for any complication resulting from childbirth
Measured: From delivery until maternal hospital discharge, assessed up to 28 days after delivery
Maternal infection
Number of participants with maternal infection, defined as the presence of at least one of the following criterias:
Fever (defined as a temperature ≥38.0 degrees Celsius). Start of intravenous broad-spectrum antibiotics (with evidence of infection confirmed by clinical and subclinical presentation).
Endometritis, myometritis or urinary tract infection (proven positive vaginal discharge/urine culture).
Measured: From induction until maternal hospital discharge, assessed up to 28 days after induction
Damage to internal organs
Number of participants with injury to internal organs, including intestines, bladder, or ureters, diagnosed clinically and/or confirmed intraoperatively during delivery or postpartum care.
Measured: From delivery until maternal hospital discharge, assessed up to 28 days after delivery
Intensive care admission
Number of participants admitted to the intensive care unit
Measured: From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Cardiorespiratory arrest
Number of participants who experienced cardiorespiratory arrest
Measured: From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Pulmonary embolus
Number of participants diagnosed with pulmonary embolism
Measured: From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Stroke
Number of participants diagnosed with stroke
Measured: From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Maternal death
Number of participants who died from any cause between randomization and maternal hospital discharge
Measured: From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Length of maternal hospital stay
Duration of stay in hospital (days)
Measured: From admission until maternal hospital discharge, assessed up to 28 days after admission
Birth trauma
Number of neonates with birth trauma, defined as the presence of at least one birth-related traumatic injury, including bone fracture, traumatic pneumothorax, facial nerve palsy, brachial plexus injury, or other clinically diagnosed birth-related trauma, identified by clinical examination and/or imaging during the neonatal hospital stay
Measured: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Hypoxic ischaemic encephalopathy or need for therapeutic hypothermia
Number of neonates with hypoxic ischemic encephalopathy or need for therapeutic hypothermia
Measured: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Meconium aspiration syndrome
Number of neonates diagnosed with meconium aspiration syndrome, defined by the presence of:
Meconium-stained amniotic fluid Respiratory distress at birth or shortly after birth Characteristic radiographic features: The initial chest film may show streaky, linear densities -> the lungs typically appear hyper-inflated with flattening of the diaphragms.
Measured: From delivery until neonatal hospital discharge, assessed up to 07 days after delivery
Need for respiratory support
Number of neonates requiring respiratory support, defined as the use of one or more of the following interventions within the first 72 hours after birth: Endotracheal intubation; Continuous Positive Airway Pressure (CPAP); High-flow nasal cannula (HFNC); Use of respiratory support as part of ventilation or cardiopulmonary resuscitation.
Measured: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Neonatal infection
Number of neonates diagnosed with neonatal infection, defined as meeting at least one of the following criteria:
Presence of a clinically ill neonate in whom systemic infection is suspected and confirmed by a positive blood culture, cerebrospinal fluid (CSF) culture, or catheterized/suprapubic urine culture; Or, in the absence of positive cultures, clinical evidence of cardiovascular collapse consistent with infection; Or radiographic evidence (e.g., chest X-ray) confirming infection.
Measured: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Neonatal seizures
Number of neonates with neonatal seizures
Measured: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Neonatal death
Number of neonates who died during the intrapartum period, neonatal period, or perinatal period
Measured: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Admission to the neonatal unit
Number of neonates admitted to the neonatal unit
Measured: From delivery until neonatal admission, assessed up to 7 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start10 Feb 2026
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Premature Rupture of Fetal MembranesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Hospital of Obstetrics and Gynecology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366359
- Sponsor's protocol ID
- NHOG.2025.POXY-PROM
- Acronym
- POXY-PROM
- Status last verified
- Feb 2026
- First submitted
- 9 Jan 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators have not yet decided whether individual participant data will be shared. As the study has not yet been conducted, there is currently limited information regarding the effectiveness of the interventions and potential risks. The decision on data sharing will depend on future considerations, including institutional policies, ethical approvals, and the establishment of appropriate data governance and data sharing agreements to ensure participant confidentiality.
Publications
Prelabor Rupture of Membranes: ACOG Practice Bulletin, Number 217. Obstet Gynecol. 2020 Mar;135(3):e80-e97. doi: 10.1097/AOG.0000000000003700.
PubMed 32080050National Institute for Health and Care Excellence (NICE). Inducing labour. NICE guideline [NG207]. London: NICE; 2021. Available from: https://www.nice.org.uk/guidance/ng207
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.
PubMed 20466294Gungorduk 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.
PubMed 21924396Gulersen 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.
PubMed 34109770Mackeen 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.
PubMed 29215519Borovac-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.
PubMed 37807591Middleton 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.
PubMed 28050900Dos 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.
PubMed 29981523
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Labor Induction Using Dinoprostone Followed by Oxytocin Versus Oxytocin Alone in Term Pregnancies With Premature Rupture of Membranes and an Unfavorable Cervix - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07366359
- Acronym / sponsor ID
- POXY-PROM / NHOG.2025.POXY-PROM
- Keywords
- Premature Rupture of Fetal Membranes, Labor Induction, Dinoprostone, Oxytocin, Cervical Ripening, Vaginal Delivery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- National Hospital of Obstetrics and GynecologyUniversity, hospital or other
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Prelabor rupture of membranes at term (term PROM) occurs in approximately 8% of pregnancies and is associated with increased risks of maternal infection, neonatal morbidity, and cesarean delivery when labor does not begin promptly. International guidelines recommend active induction of labor for women with term PROM; however, the optimal induction strategy for women presenting with an unfavorable cervix (Bishop score ≤ 6) remains uncertain.
Oxytocin is widely used for induction of labor and is effective when the cervix is favorable, but its efficacy may be reduced in the presence of an unripe cervix. Prostaglandin E2 (dinoprostone) is commonly used for cervical ripening and may improve the likelihood of vaginal delivery when administered prior to oxytocin. Previous randomized trials comparing dinoprostone followed by oxytocin with oxytocin alone have suggested potential benefits, but the available evidence is limited by small sample sizes and inconsistent results. Additional high-quality randomized evidence is therefore required to guide clinical practice in this population.
This randomized controlled trial compares two induction strategies for women with term PROM and an unfavorable cervix: (1) cervical ripening using a 6-hour vaginal dinoprostone (Propess) insert followed by intravenous oxytocin if labor has not commenced, and (2) immediate induction with intravenous oxytocin alone. Both interventions are routinely used in clinical practice in Vietnam and are considered safe.
Participants are randomly assigned in a 1:1 ratio using a computer-generated randomization sequence with variable block sizes of 4 and 6, with allocation concealment ensured through centralized randomization. Randomization is performed after confirmation of eligibility and completion of the informed consent process. Participants remain in their assigned study arm throughout the trial, and no crossover between arms is permitted. All aspects of intrapartum care, including fetal heart rate monitoring, assessment of labor progress, and management of uterine tachysystole or other complications, are conducted according to standard institutional protocols.
The primary outcome of the study is vaginal delivery. Secondary outcomes are selected in accordance with the internationally developed core outcome set for trials on induction of labour and include key maternal, neonatal, and patient-reported outcomes. Maternal outcomes include mode of delivery, time from induction to delivery, need for oxytocin augmentation, uterine hyperstimulation, postpartum hemorrhage, maternal infection, admission to intensive care, hysterectomy, and maternal death. Neonatal outcomes include Apgar scores, admission to the neonatal intensive care unit, neonatal infection, hypoxic-ischemic encephalopathy or need for therapeutic hypothermia, and neonatal death. Patient-reported outcomes, including overall labor pain and maternal satisfaction with the birth process, are also assessed.
A total sample size of 450 participants has been calculated to provide adequate statistical power while accounting for potential attrition. The findings of this study are expected to clarify whether cervical ripening with dinoprostone prior to oxytocin induction improves clinically meaningful outcomes for women with term PROM and an unfavorable cervix, and may help inform future national and international guidelines on induction of labor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dinoprostone (Propess) + Oxytocin | Experimental | Drug: Sequential Induction: Dinoprostone Followed by OxytocinParticipants 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. |
| Immediate Oxytocin Induction | Active comparator | Drug: Immediate Oxytocin InductionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Cephalic presentation
Key exclusion criteria (6 listed)
- Active labor
- Previous uterine surgery (e.g., cesarean section)
- Chorioamnionitis or non-reassuring fetal status
- Major fetal anomalies
- Contraindications to prostaglandin or vaginal delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sequential Induction: Dinoprostone Followed by OxytocinAlso: Dinoprostone (Propess)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. | Drug | Dinoprostone (Propess) + Oxytocin |
| Immediate Oxytocin InductionAlso: OxytocinIntravenous 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. | Drug | Immediate Oxytocin Induction |
Primary outcome
Vaginal delivery
Time frame: From induction until delivery, assessed up to 36 hours after randomization
Number of participants delivered vaginally
24 secondary outcomes
Mode of delivery
Time frame: Within 24 hours from labor induction
Time from induction of labor to delivery
Time frame: From induction until delivery, assessed up to 24 hours after induction
Oxytocin augmentation
Time frame: From induction until delivery, assessed up to 24 hours after induction
Uterine hyperstimulation
Time frame: From induction until delivery, assessed up to 24 hours after induction
Maternal satisfaction
Time frame: Once between 90 minutes and 3 hours after delivery
Haemorrhage
Time frame: Within 24 hours from delivery
Uterine rupture
Time frame: From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Hysterectomy for any complications resulting from birth
Time frame: From delivery until maternal hospital discharge, assessed up to 28 days after delivery
Maternal infection
Time frame: From induction until maternal hospital discharge, assessed up to 28 days after induction
Damage to internal organs
Time frame: From delivery until maternal hospital discharge, assessed up to 28 days after delivery
Intensive care admission
Time frame: From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Cardiorespiratory arrest
Time frame: From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Pulmonary embolus
Time frame: From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Stroke
Time frame: From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Maternal death
Time frame: From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Length of maternal hospital stay
Time frame: From admission until maternal hospital discharge, assessed up to 28 days after admission
Birth trauma
Time frame: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Hypoxic ischaemic encephalopathy or need for therapeutic hypothermia
Time frame: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Meconium aspiration syndrome
Time frame: From delivery until neonatal hospital discharge, assessed up to 07 days after delivery
Need for respiratory support
Time frame: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Neonatal infection
Time frame: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Neonatal seizures
Time frame: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Neonatal death
Time frame: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Admission to the neonatal unit
Time frame: From delivery until neonatal admission, assessed up to 7 days after delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Results publication: PubMed 32080050Prelabor Rupture of Membranes: ACOG Practice Bulletin, Number 217. Obstet Gynecol. 2020 Mar;135(3):e80-e97. doi: 10.1097/AOG.0000000000003700.
- Results publicationNational Institute for Health and Care Excellence (NICE). Inducing labour. NICE guideline [NG207]. London: NICE; 2021. Available from: https://www.nice.org.uk/guidance/ng207
- Results publication: PubMed 20466294Kunt 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.
- Results publication: PubMed 21924396Gungorduk 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.
- Results publication: PubMed 34109770Gulersen 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.
- Results publication: PubMed 29215519Mackeen 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.
- Results publication: PubMed 37807591Borovac-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.
- Results publication: PubMed 28050900Middleton 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.
- Results publication: PubMed 29981523Dos 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.
- 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; 2021Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The investigators have not yet decided whether individual participant data will be shared. As the study has not yet been conducted, there is currently limited information regarding the effectiveness of the interventions and potential risks. The decision on data sharing will depend on future considerations, including institutional policies, ethical approvals, and the establishment of appropriate data governance and data sharing agreements to ensure participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sequential Induction: Dinoprostone Followed by Oxytocin and Immediate Oxytocin Induction in people with Premature Rupture of Fetal Membranes and Labor, Induced, run by National Hospital of Obstetrics and Gynecology at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Khuyen T.H Truong, MD (+84983851754, khuyenth.hmu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal delivery (time frame: From induction until delivery, assessed up to 36 hours after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07366359, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.