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

Not Applicable

Completed

• Conditions: Failed Induction of Labor
• Interventions: Drug: Oxytocin; Procedure: Membrane sweeping; Drug: Dinoprostone

• Registration Number: NCT02416583
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-01
• Study First Submitted QC: 2015-04-14
• Study First Posted: 2015-04-15
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-29
• Last Update Posted: 2020-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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

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	Dinoprostone	For 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	Oxytocin	For 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.concurrent membrane sweeping with dinoprostone or only 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.concurrent membrane sweeping with dinoprostone or only 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)	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
Successful labor induction	From 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 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