- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04412915
Correlation Between Early Induction of Labor and Cesarean Delivery in Low-risk Nulliparous Women
February 7, 2022 updated by: Sheng-Mou Hsiao, Far Eastern Memorial Hospital
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.
Study Overview
Detailed Description
Medical records of all consecutive primiparas with low-risk pregnancy from January 1, 2014 to August 31, 2019 were reviewed to explore the correlation between early induction of labor and caesarean birth after 38 + 0 weeks.
The hypothesis of the study is that 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.
Study Type
Observational
Enrollment (Actual)
2125
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
-
-
New Taipei
-
Banqiao, New Taipei, Taiwan, 22050
- Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
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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
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Medical records of all consecutive primiparas with low-risk pregnancy from January 1, 2014 to August 31, 2019
Description
Inclusion Criteria:
- After 38 + 0 weeks of gestation
- low-risk pregnant primiparas
- singleton
- nulliparous
- > 20 years old
Exclusion Criteria:
- Premature rupture of membranes
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cesarean rate rate
Time Frame: 10 years
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
May 21, 2020
Primary Completion (Actual)
June 4, 2021
Study Completion (Actual)
August 23, 2021
Study Registration Dates
First Submitted
May 31, 2020
First Submitted That Met QC Criteria
May 31, 2020
First Posted (Actual)
June 2, 2020
Study Record Updates
Last Update Posted (Actual)
February 8, 2022
Last Update Submitted That Met QC Criteria
February 7, 2022
Last Verified
December 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 109050-F
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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