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

NCT02866058 | Completed

• 1 other identifier: MRFCoxAwardAubrey2
• Study Type: observational
• Target: 1,703,590
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pregnancy Complications; Cesarean Section

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cesarean

Mothers delivered by cesarean section

Procedure: Cesarean Section

Vaginal

Mothers delivered by vaginal delivery

Interventions

Cesarean Section PROCEDURE

Cesarean

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial University of Newfoundland: lead
• Medical Research Foundation - Memorial University: collaborator

MeSH Terms

Conditions

Pregnancy Complications

Interventions

Cesarean Section

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Kris Aubrey-Bassler, MD

  Memorial University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Primary Healthcare Research Unit

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 15, 2016
• Study Start: May 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2015
• Last Updated: August 15, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share