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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02416583

Collaborator

(none)

140

Enrollment

Location

Arms

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Failed Induction of Labor	Drug: Oxytocin Drug: Dinoprostone Procedure: Membrane sweeping	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Jul 1, 2018

Actual Study Completion Date :

Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Oxytocin & 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	Drug: Oxytocin Procedure: Membrane sweeping
Active Comparator: Oxytocin & 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	Drug: Oxytocin Drug: Dinoprostone

Arm

Intervention/Treatment

Active Comparator: Oxytocin & 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

Drug: Oxytocin

Procedure: Membrane sweeping

Active Comparator: Oxytocin & 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

Drug: Oxytocin

Drug: Dinoprostone

Outcome Measures

Primary Outcome Measures

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

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
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
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Obstetrics and Gynecology Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do	Korea, Republic of	463-707

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator: Kyo Hoon Park, MD, PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kyo Hoon Park, MD, Professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT02416583

Other Study ID Numbers:

SWP_PG_N2

First Posted:

Apr 15, 2015

Last Update Posted:

Mar 3, 2020

Last Verified:

Feb 1, 2020

Keywords provided by Kyo Hoon Park, MD, Professor, Seoul National University Hospital

Additional relevant MeSH terms:

Oxytocin

Dinoprostone

Study Results

No Results Posted as of Mar 3, 2020