- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03918044
Obesity Among Young Adult Males Born With Cesarean Section.
March 27, 2023 updated by: Daniel Berglind, Karolinska Institutet
Elective and Non-elective Cesarean Section and the Risk for Obesity Among Young Male Conscripts: a Population-based Cohort and Matched-sibling Analysis.
Previous research has suggested that cesarean section may be associated with an increased risk of developing obesity in childhood, adolescence and adulthood.
Yet, previous studies have been small or unable to differentiate between elective and non-elective cesarean section.
Therefore, using a population-based cohort the purpose is to examine the associations between vaginal delivery, elective and non-elective cesarean section on the risk of developing obesity in young adulthood among Swedish young singleton males.
Using the Swedish medical birth registry, the recorded mode of delivery and indication of delivery which will be matched to those males who perform military conscription, where their body mass index is recorded.
The investigators hypothesize that there will be an elevated risk of obesity in those born with non-elective cesarean section, as a function of confounding, while those born with elective cesarean section will not have a higher risk of obesity than those born with vaginal delivery.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
97291
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
-
-
-
Stockholm, Sweden, 113 65
- Karolinska Institutet
-
-
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
Male
Sampling Method
Probability Sample
Study Population
All singleton born in Sweden between 1982 and 1987.
Description
Inclusion Criteria:
- Singleton birth.
- Retrievable from medical birth registry.
Exclusion Criteria:
- No available information on mode of delivery.
- Not conscripted.
- Extreme values at conscription.
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 |
Measure Description |
Time Frame |
|---|---|---|
|
Categories of body mass index
Time Frame: Measured at conscription (~18 years of age)
|
World health organisation categories of body mass index: underweight BMI<18.5, normal weight BMI 18.5-24.9,
overweight BMI 25-29.9 and obese BMI>30.
Weight at conscription was measured using standardized scales and height was assessed using stadiometers in a standardized manner.
|
Measured at conscription (~18 years of age)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Continuous body mass index
Time Frame: Measured at conscription (~18 years of age)
|
Measured continuous body mass index
|
Measured at conscription (~18 years of age)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
April 30, 2019
Primary Completion (Actual)
August 1, 2019
Study Completion (Actual)
August 30, 2019
Study Registration Dates
First Submitted
April 14, 2019
First Submitted That Met QC Criteria
April 14, 2019
First Posted (Actual)
April 17, 2019
Study Record Updates
Last Update Posted (Actual)
March 28, 2023
Last Update Submitted That Met QC Criteria
March 27, 2023
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20190405
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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