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Obesity Among Young Adult Males Born With Cesarean Section.

Sponsor
Karolinska Institutet (Other)
Overall Status
Unknown status
CT.gov ID
NCT03918044
Collaborator
(none)
97,291
Enrollment
1
Location
4
Anticipated Duration (Months)
24272.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    97291 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Elective and Non-elective Cesarean Section and the Risk for Obesity Among Young Male Conscripts: a Population-based Cohort and Matched-sibling Analysis.
    Actual Study Start Date :
    Apr 30, 2019
    Actual Primary Completion Date :
    Aug 1, 2019
    Anticipated Study Completion Date :
    Aug 30, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Categories of body mass index [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.

    Secondary Outcome Measures

    1. Continuous body mass index [Measured at conscription (~18 years of age)]

      Measured continuous body mass index

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Singleton birth.

    • Retrievable from medical birth registry.

    Exclusion Criteria:

    • No available information on mode of delivery.

    • Not conscripted.

    • Extreme values at conscription.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Karolinska Institutet Stockholm Sweden 113 65

    Sponsors and Collaborators

    • Karolinska Institutet

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Daniel Berglind, Principal Investigator, Karolinska Institutet
    ClinicalTrials.gov Identifier:
    NCT03918044
    Other Study ID Numbers:
    • 20190405
    First Posted:
    Apr 17, 2019
    Last Update Posted:
    Aug 28, 2019
    Last Verified:
    Aug 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Daniel Berglind, Principal Investigator, Karolinska Institutet
    Obesity
    Cesarean Section
    Vaginal Delivery
    Elective Cesarean Section
    Non-elective Cesarean Section
    Additional relevant MeSH terms:
    Obesity

    Study Results

    No Results Posted as of Aug 28, 2019