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

Cesarean Section Clinical Trial

Official title:

Substantial Variability Between Traditional and Instrumental Variable Estimates of the Risk of Caesarean Section in Canada: a Population-based Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02866058
• Other study ID #: MRFCoxAwardAubrey2
• Status: Completed
• Phase: N/A
• First received: August 4, 2016
• Last updated: August 12, 2016
• Start date: May 2011
• Est. completion date: July 2015

Study information

• Verified date: August 2016
• Source: Memorial University of Newfoundland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Human Investigations Committee (now the Health Research Ethics Board)
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1703590
• Est. completion date: July 2015
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cesarean Section
• Pregnancy Complications

Intervention

Procedure:
• Cesarean Section

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Memorial University of Newfoundland	Medical Research Foundation - Memorial University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perinatal Mortality	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.	up to 7 days	Yes