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Obesity Among Young Adult Males Born With Cesarean Section.

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ClinicalTrials.gov Identifier: NCT03918044
Recruitment Status : Unknown
Verified August 2019 by Daniel Berglind, Karolinska Institutet.
Recruitment status was:  Active, not recruiting
First Posted : April 17, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Daniel Berglind, Karolinska Institutet

Study Description
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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
Caesarean Section Obesity Cesarean Section Complications

Study Design
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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 : April 30, 2019
Actual Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Continuous body mass index [ Time Frame: Measured at conscription (~18 years of age) ]
    Measured continuous body mass index


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All singleton born in Sweden between 1982 and 1987.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918044


Locations
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Sweden
Karolinska Institutet
Stockholm, Sweden, 113 65
Sponsors and Collaborators
Karolinska Institutet
  Study Documents (Full-Text)

Documents provided by Daniel Berglind, Karolinska Institutet:
Study Protocol and Statistical Analysis Plan  [PDF] April 24, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Daniel Berglind, Principal Investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03918044    
Other Study ID Numbers: 20190405
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniel Berglind, Karolinska Institutet:
Obesity
Cesarean Section
Vaginal Delivery
Elective Cesarean Section
Non-elective Cesarean Section
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight