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

Failed Induction of Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02416583
• Other study ID #: SWP_PG_N2
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: July 2018

Study information

• Verified date: February 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Failed Induction of Labor

Intervention

Drug:
• Oxytocin

• Dinoprostone

Procedure:
• Membrane sweeping

Locations

Country	Name	City	State
Korea, Republic of	Department of Obstetrics and Gynecology Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal delivery within 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.	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
Secondary	Successful labor induction	to achieve the active phase of labor corresponding to a cervical dilatation of >=4cm	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
Secondary	Incidence of cesarean delivery	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	End of labor induction (assessed up to 120 hours)
Secondary	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