NCT01792375

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

March 4, 2020

Status Verified

October 1, 2016

Enrollment Period

5 years

First QC Date

February 13, 2013

Last Update Submit

March 1, 2020

Conditions

Nulliparous Women Who Scheduled for Labor Induction

Keywords

Cervical ripeningDinoprostoneLabor inductionMembrane sweepingNulliparous womenTrial

Outcome Measures

Primary Outcomes (1)

  • 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.

    Twenty-four hours of initiating intervention (i.e. membrane sweeping or PG) on the first day of induction

Secondary Outcomes (1)

  • Cervical change in the bishop scores and cervical lengths

    Initiation of oxytocin after removing dinoprostone vaginal insert

Study Arms (2)

Concurrent membrane sweeping with Dinoprostone

ACTIVE COMPARATOR
Procedure: Concurrent membrane sweeping with Dinoprostone

Dinoprostone

ACTIVE COMPARATOR
Drug: 10mg Dinoprostone vaginal insert

Interventions

Concurrent membrane sweeping with DinoprostonePROCEDURE

Women assigned to "Sweep" had their cervix swept by inserting the examining finger as high as possible past the internal cervical os, immediately followed by the placement of a 10mg Dinoprostone vaginal insert in the posterior fornix.

Concurrent membrane sweeping with Dinoprostone
10mg Dinoprostone vaginal insertDRUG

For women assigned to "No sweep": The only 10mg Dinoprostone vaginal insert were placed in the posterior fornix for cervical ripening

Dinoprostone

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Multiple pregnancy
  • Placenta previa

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Interventions

Dinoprostone

Intervention Hierarchy (Ancestors)

Prostaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Kyo Hoon Park, MD, PhD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2013

First Posted

February 15, 2013

Study Start

February 1, 2013

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

March 4, 2020

Record last verified: 2016-10

Locations

KR(1)