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Concurrent Oxytocin With Membrane Sweeping Versus Dinoprostone Pessary in Labor Induction of Nulliparas at Term

Concurrent Oxytocin With Membrane Sweeping Versus Dinoprostone Pessary in Labor Induction of Nulliparas at Term

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02416583
Enrollment
140
Registered
2015-04-15
Start date
2015-04-30
Completion date
2018-07-31
Last updated
2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Failed Induction of Labor

Keywords

membrane sweeping, dinoprostone, nulliparas, labor induction

Brief summary

To compare concurrent oxytocin with membrane sweeping versus dinoprostone pessary in labor induction for nulliparas at term with an unfavorable cervix

Interventions

DRUGOxytocin
DRUGDinoprostone

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* singleton pregnancy * Nulliparous women * gestational age \>=37.0 weeks * Bishop score \<=6 * intact amniotic membrane * absence of labor * live fetus with vertex presentation * no previous uterine surgical procedure

Exclusion criteria

* Multiple pregnancy * Placenta previa

Design outcomes

Primary

MeasureTime frameDescription
Vaginal delivery within 24 hoursFrom the time of initiating intervention (i.e.concurrent membrane sweeping with dinoprostone or only dinoprostone) until the time of vaginal delivery, assessed up to 24 hoursVaginal delivery within 24 hours is defined as vaginal delivery after 24 hours of initiating intervention (i.e.concurrent membrane sweeping with dinoprostone or only dinoprostone) on the first day of induction.

Secondary

MeasureTime frameDescription
Successful labor inductionFrom the time of initiating intervention (i.e.concurrent membrane sweeping with dinoprostone or only dinoprostone) until the time of active phase of labor ( defined as a cervical dilatation of >=4cm), assessed up to 24 hoursto achieve the active phase of labor corresponding to a cervical dilatation of \>=4cm
Incidence of cesarean deliveryEnd of labor induction (assessed up to 120 hours)From the time of initiating intervention (i.e.concurrent membrane sweeping with dinoprostone or only dinoprostone) until the time of cesarean delivery, assessed up to 120 hours
The interval from start of oxytocin to deliveryFrom the time of initiating oxytocin infusion until the time of delivery, assessed up to 120 hours

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026