- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02618096
Concurrent Oxytocin With Membrane Sweeping Versus Dinoprostone Pessary in Labor Induction of Multiparous Women at Term
March 1, 2020 updated by: Seoul National University Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
154
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
- Department of Obstetrics and Gynecology Seoul National University Bundang Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
|
Active Comparator: Oxytocin & 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vaginal delivery within 24 hours
Time Frame: 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.
|
From the time of initiating intervention (i.e. membrane sweeping or dinoprostone) until the time of vaginal delivery, assessed up to 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The interval from start of oxytocin to delivery
Time Frame: From the time of initiating oxytocin infusion until the time of delivery, assessed up to 120 hours
|
From the time of initiating oxytocin infusion until the time of delivery, assessed up to 120 hours
|
|
Successful labor induction
Time Frame: 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
|
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
|
Incidence of cesarean delivery
Time Frame: End of labor induction (assessed up to 120 hours)
|
End of labor induction (assessed up to 120 hours)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kyo Hoon Park,, MD, PhD, Seoul National University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Actual)
October 1, 2018
Study Completion (Actual)
October 1, 2018
Study Registration Dates
First Submitted
September 25, 2015
First Submitted That Met QC Criteria
November 25, 2015
First Posted (Estimate)
December 1, 2015
Study Record Updates
Last Update Posted (Actual)
March 4, 2020
Last Update Submitted That Met QC Criteria
March 1, 2020
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SWP_PG_M2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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