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Completed

NCT Number: NCT02866058

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

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

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Key information

Conditions

Pregnancy Complications Cesarean Section Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cesarean section

Procedure

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Memorial University of Newfoundland

Other

Collaborators

  • Medical Research Foundation - Memorial University

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2015
First posted
Aug 15, 2016
Registry last updated
Aug 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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