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

Completed

• Conditions: Pregnancy Complications; Cesarean Section
• Interventions: Procedure: Cesarean Section

• Registration Number: NCT02866058
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2013-07
• Study Completion: 2015-07
• Status Verified: 2016-08
• Study First Submitted: 2016-08-04
• Study First Submitted QC: 2016-08-12
• Last Update Submitted: 2016-08-12
• Study First Posted: 2016-08-15
• Last Update Posted: 2016-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1703590

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cesarean	Cesarean Section	Mothers delivered by cesarean section

Primary Outcome Measures

Name	Time	Method
Perinatal Mortality	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.