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Outcomes of Cesarean Section vs Vaginal Delivery: Instrumental Variable Adjusted Analysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02866058
Recruitment Status : Completed
First Posted : August 15, 2016
Last Update Posted : August 15, 2016
Medical Research Foundation - Memorial University
Information provided by (Responsible Party):
Kris Aubrey-Bassler, Memorial University of Newfoundland

Brief Summary:
This study will examine the effect of cesarean section on perinatal mortality, using data provided by the Canadian Institute for Health Information.

Condition or disease Intervention/treatment
Pregnancy Complications Cesarean Section Procedure: Cesarean Section

Detailed Description:
This study will examine administrative data provided by the Canadian Institute for Health Information (CIHI). Maternal obstetrical delivery and neonatal hospitalization records provided by CIHI will be linked before analysis. The primary outcome is in-hospital perinatal mortality. The data will be analyzed by traditional multi-variate logistic regression, and the results from this analysis will be compared to the results from instrumental variable adjusted regression using the Generalized Method of Moments. The instrumental variable is the rate of cesarean delivery among women living within the same hospital catchment area. All analyses will be adjusted for maternal, infant, delivery provider, and hospital factors, as well as for clustering at the level of the delivery hospital.

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Study Type : Observational
Actual Enrollment : 1703590 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Substantial Variability Between Traditional and Instrumental Variable Estimates of the Risk of Caesarean Section in Canada: a Population-based Cohort Study
Study Start Date : May 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Group/Cohort Intervention/treatment
Mothers delivered by cesarean section
Procedure: Cesarean Section
Mothers delivered by vaginal delivery

Primary Outcome Measures :
  1. Perinatal Mortality [ Time Frame: up to 7 days ]
    Includes deaths at any age if infant continuously hospitalized (including transfers) in an acute care facility. Includes deaths up to 7 days of age if infant discharged from hospital then readmitted prior to 7 days of age.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All obstetrical deliveries in Canada (except the province of Quebec) between April 1, 2006 and March 31, 2009

Inclusion Criteria:

  • Mothers living in Canada and their infants delivering within the study period at Canadian hospitals outside of the province of Quebec.

Exclusion Criteria:

  • Maternal record not linkable to neonatal record.
  • Multiple gestation.
  • Birthweight < 500 gm.
  • Gestational age at delivery < 20 weeks.
  • Deliveries at hospitals with less than 20 cesarean deliveries during study period.
  • Records with missing data for important covariates

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 identifier (NCT number): NCT02866058

Sponsors and Collaborators
Memorial University of Newfoundland
Medical Research Foundation - Memorial University
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Principal Investigator: Kris Aubrey-Bassler, MD Memorial University
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Responsible Party: Kris Aubrey-Bassler, Director, Primary Healthcare Research Unit, Memorial University of Newfoundland Identifier: NCT02866058    
Other Study ID Numbers: MRFCoxAwardAubrey2
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data provider does not allow sharing of investigator data, but data can be requested directly from them.
Additional relevant MeSH terms:
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Pregnancy Complications