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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03918044
Other study ID # 20190405
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 30, 2019
Est. completion date August 30, 2019

Study information

Verified date August 2019
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 97291
Est. completion date August 30, 2019
Est. primary completion date August 1, 2019
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Sweden Karolinska Institutet Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Categories of body mass index 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 Continuous body mass index Measured continuous body mass index Measured at conscription (~18 years of age)
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