Concurrent Oxytocin With Membrane Sweeping Versus Dinoprostone Pessary in Labor Induction of Multiparous Women at Term
Not Applicable
Completed
- Conditions
- Failed Induction of Labor
- Interventions
- Registration Number
- NCT02618096
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
The purpose of this study is to compare concurrent oxytocin with membrane sweeping versus dinoprostone pessary in labor induction for multiparas at term with an unfavorable cervix.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 154
Inclusion Criteria
- singleton pregnancy
- Multiparous 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oxytocin & Membrane sweeping Membrane sweeping Women assigned to "Concurrent oxytocin with membrane sweeping" had their cervix swept by inserting the examining finger as high as possible past the internal cervical os, followed by oxytocin infusion the next day Oxytocin & Membrane sweeping Oxytocin Women assigned to "Concurrent oxytocin with membrane sweeping" had their cervix swept by inserting the examining finger as high as possible past the internal cervical os, followed by oxytocin infusion the next day Oxytocin & Dinoprostone Oxytocin Women assigned to "Concurrent oxytocin with dinoprostone vaginal insert": The 10mg dinoprostone vaginal insert were placed in the posterior fornix for cervical ripening, followed by oxytocin infusion the next day Oxytocin & Dinoprostone Dinoprostone Women assigned to "Concurrent oxytocin with dinoprostone vaginal insert": The 10mg dinoprostone vaginal insert were placed in the posterior fornix for cervical ripening, followed by oxytocin infusion the next day
- Primary Outcome Measures
Name Time Method Vaginal delivery within 24 hours From the time of initiating intervention (i.e. membrane sweeping or dinoprostone) until the time of vaginal delivery, assessed up to 24 hours Vaginal delivery within 24 hours is defined as vaginal delivery after 24 hours of initiating intervention (i.e. membrane sweeping or dinoprostone) on the first day of induction.
- Secondary Outcome Measures
Name Time Method Incidence of cesarean delivery End of labor induction (assessed up to 120 hours) Successful labor induction From the time of initiating intervention (i.e. membrane sweeping or dinoprostone) until the time of active phase of labor (defined as a cervical dilatation of >=4cm), assessed up to 24 hours to achieve the active phase of labor corresponding to a cervical dilatation of \>=4cm
The interval from start of oxytocin to delivery From the time of initiating oxytocin infusion until the time of delivery, assessed up to 120 hours
Trial Locations
- Locations (1)
Department of Obstetrics and Gynecology Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Department of Obstetrics and Gynecology Seoul National University Bundang Hospital🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of