Concurrent Membrane Sweeping With Dinoprostone Versus Dinoprostone in Labor Induction of Nulliparas at Term With an Unfavorable Cervix

Not Applicable

Completed

• Conditions: Nulliparous Women Who Scheduled for Labor Induction
• Interventions: Procedure: Concurrent membrane sweeping with Dinoprostone; Drug: 10mg Dinoprostone vaginal insert

• Registration Number: NCT01792375
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-13
• Study First Submitted QC: 2013-02-13
• Study First Posted: 2013-02-15
• Status Verified: 2016-10
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Last Update Submitted: 2020-03-01
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 192

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

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Exclusion Criteria

• Multiple pregnancy
• Placenta previa

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Concurrent membrane sweeping with Dinoprostone	Concurrent membrane sweeping with Dinoprostone	-
Dinoprostone	10mg Dinoprostone vaginal insert	-

Primary Outcome Measures

Name	Time	Method
Vaginal delivery within 24 hours	Twenty-four hours of initiating intervention (i.e. membrane sweeping or PG) on the first day of induction	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
Cervical change in the bishop scores and cervical lengths	Initiation of oxytocin after removing dinoprostone vaginal insert	1. Cervical change based on the bishop score and cervical length induced by two cervical ripening methods(concurrent membrane sweeping with dinoprostone vs. dinoprostone); 2. Incidence of cesarean delivery; 3. Successful labor induction (defined as an ability to achieve the active phase of labor corresponding to a cervical dilatation of \>=4cm).; 4. The interval from start of oxytocin to delivery; 5. Incidence of rupture of membranes; 6. Incidences of vaginal bleeding and fever

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of