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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02866058

Enrollment

1703590

Registered

2016-08-15

Start date

2011-05-31

Completion date

2015-07-31

Last updated

2016-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section, Pregnancy Complications

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.

Interventions

PROCEDURECesarean Section

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026