Caesarean SectionNCT03918044
Obesity Among Young Adult Males Born With Cesarean Section.
An observational study of Caesarean Section and Obesity, run by Karolinska Institutet at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Caesarean Section, Obesity, Cesarean Section Complications
- How many people
- 97,291 participants
- Where
- 1 siteSweden
- Study dates
- 30 Apr 2019to 30 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All singleton born in Sweden between 1982 and 1987.
Who may be able to join
- Singleton birth.
- Retrievable from medical birth registry.
Who cannot join
- No available information on mode of delivery.
- Not conscripted.
- Extreme values at conscription.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Caesarean Section, Obesity, Cesarean Section Complications
- Keywords
- Obesity, Cesarean Section, Vaginal Delivery, Elective Cesarean Section, Non-elective Cesarean Section
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at conscription (~18 years of age)
Secondary outcomes (1)
Continuous body mass index
Measured continuous body mass index
Measured: Measured at conscription (~18 years of age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start30 Apr 2019
- Primary completion1 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caesarean SectionStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 97,291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Berglind, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918044
- Sponsor's protocol ID
- 20190405
- Status last verified
- Aug 2019
- First submitted
- 14 Apr 2019
- Last updated
- 28 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ahlqvist VH, Persson M, Magnusson C, Berglind D. Elective and nonelective cesarean section and obesity among young adult male offspring: A Swedish population-based cohort study. PLoS Med. 2019 Dec 6;16(12):e1002996. doi: 10.1371/journal.pmed.1002996. eCollection 2019 Dec.
PubMed 31809506
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03918044
- Acronym / sponsor ID
- 20190405
- Conditions
- Caesarean Section, Obesity, Cesarean Section Complications
- Keywords
- Obesity, Cesarean Section, Vaginal Delivery, Elective Cesarean Section, Non-elective Cesarean Section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97,291 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 17 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All singleton born in Sweden between 1982 and 1987.
Key inclusion criteria (2 listed)
- Singleton birth.
- Retrievable from medical birth registry.
Key exclusion criteria (3 listed)
- No available information on mode of delivery.
- Not conscripted.
- Extreme values at conscription.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Continuous body mass index
Time frame: Measured at conscription (~18 years of age)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Derived from this study: PubMed 31809506Ahlqvist VH, Persson M, Magnusson C, Berglind D. Elective and nonelective cesarean section and obesity among young adult male offspring: A Swedish population-based cohort study. PLoS Med. 2019 Dec 6;16(12):e1002996. doi: 10.1371/journal.pmed.1002996. eCollection 2019 Dec.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caesarean Section and Obesity, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Categories of body mass index (time frame: Measured at conscription (~18 years of age)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03918044, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.