NCT04412915

Brief Summary

To elucidate whether induction of labor in primiparas with low-risk pregnancies at 38 + 0 to 40 + 6 gestational weeks will increase the cesarean rate, compared with those receiving labor induction at more than 41+0 gestational weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,125

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

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

May 21, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 31, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2021

Completed
Last Updated

February 8, 2022

Status Verified

December 1, 2021

Enrollment Period

1 year

First QC Date

May 31, 2020

Last Update Submit

February 7, 2022

Conditions

Low Risk Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Cesarean rate rate

    10 years

Interventions

Labor inductionOTHER

Labor induction with oxytocin or prostagladin

Eligibility Criteria

Age20 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsprimiparas
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Medical records of all consecutive primiparas with low-risk pregnancy from January 1, 2014 to August 31, 2019

You may qualify if:

  • After 38 + 0 weeks of gestation
  • low-risk pregnant primiparas
  • singleton
  • nulliparous
  • \> 20 years old

You may not qualify if:

  • Premature rupture of membranes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

Location

MeSH Terms

Interventions

Labor, Induced

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Department of Obstetrics & Gynecology

Study Record Dates

First Submitted

May 31, 2020

First Posted

June 2, 2020

Study Start

May 21, 2020

Primary Completion

June 4, 2021

Study Completion

August 23, 2021

Last Updated

February 8, 2022

Record last verified: 2021-12

Locations

TW(1)