Which labor induction method is safer for moms and babies?
NCT ID NCT07366359
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at two common methods to start labor in pregnant women whose water breaks before labor begins (term PROM) and whose cervix is not yet ready. One group gets a vaginal insert (dinoprostone) to soften the cervix, followed by oxytocin if needed. The other group gets oxytocin right away. The goal is to see which method leads to more vaginal births and fewer complications for mother and baby. About 450 women in Hanoi, Vietnam will take part.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dinoprostone (Propess) and Oxytocin
- What this could lead to
- If this trial succeeds, it could help doctors choose the best way to start labor for women whose water breaks early, potentially leading to more vaginal births and fewer complications.
- What could go wrong
- This is a single-center study in Vietnam, so results may not apply everywhere. The trial is not blinded, which could introduce bias. Both methods are already used, so no major new risks are expected.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 450 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Hospital of Obstetrics and Gynecology
RECRUITINGHanoi, Hanoi, 100000, Vietnam
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Other studies related to the condition(s) this trial covers.
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- Could a simple test during pregnancy prevent premature birth?
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- Which Labor-Inducing drug works best for First-Time moms?