PGE2 Followed by Oxytocin vs Oxytocin in Term PROM (POXY-PROM)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNational Hospital of Obstetrics and Gynecology
About this 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.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Amniotic fluid visibly draining from the cervical os during sterile speculum examination
Disqualifiers
Active labor
Previous uterine surgery (e.g., cesarean section)
Chorioamnionitis or non-reassuring fetal status
Major fetal anomalies
Trial design
Design model
Parallel
Treatments tested in this trial
Sequential Induction: Dinoprostone Followed by Oxytocin
DrugA 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 Induction
DrugIntravenous 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.
Treatment groups
450 Participants
are divided into 2 treatment groupsGroup A: Dinoprostone (Propess) + OxytocinExperimental treatment 1 intervention
Group B: Immediate Oxytocin InductionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Vaginal delivery
Number of participants delivered vaginally
Time frame
From induction until delivery, assessed up to 36 hours after randomizationSecondary outcomes
1
Mode of delivery
Number of participants according to mode of delivery, categorized as vaginal delivery, operative vaginal delivery (forceps), or cesarean section
Time frame
Within 24 hours from labor induction2
Time from induction of labor to delivery
Duration from induction of labor to delivery (hours)
Time frame
From induction until delivery, assessed up to 24 hours after induction3
Oxytocin augmentation
Number of participants in the intervention group (Group I) who received intravenous oxytocin during the induction process
Time frame
From induction until delivery, assessed up to 24 hours after induction4
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
Time frame
From induction until delivery, assessed up to 24 hours after inductionOther outcomes
1
Vaginal delivery within 12 hours
Number of participants delivered vaginally within 12 hours
Time frame
From induction until delivery, assessed up to 12 hours after induction2
Reaching active phase of labor
Number of participants who developed regular uterine contractions accompanied by cervical dilation of ≥5 cm, as assessed by a qualified obstetric provider
Time frame
From induction until reaching active phase, assessed up to 12 hours after induction3
Time from induction to dinoprostone insert removal
Duration from induction to dinoprostone vaginal insert removal (hours). Applicable to participants in the dinoprostone insert arm only
Time frame
From induction until dinoprostone vaginal insert removal, assessed up to 12 hours after induction4
Time from induction to active phase of labor
Duration from induction to active phase of labor (hours)
Time frame
From induction until reaching active phase of labor, assessed up to 12 hours after inductionSponsors and contacts
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Source ClinicalTrials.gov