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

NCT ID: NCT02866058

Last Updated: 2016-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1703590 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2015-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pregnancy Complications Cesarean Section

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cesarean

Mothers delivered by cesarean section

Cesarean Section

Intervention Type PROCEDURE

Vaginal

Mothers delivered by vaginal delivery

No interventions assigned to this group

Interventions

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Cesarean Section

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical Research Foundation - Memorial University

UNKNOWN

Sponsor Role collaborator

Memorial University of Newfoundland

OTHER

Sponsor Role lead

Responsible Party

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Kris Aubrey-Bassler

Director, Primary Healthcare Research Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kris Aubrey-Bassler, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial University

Other Identifiers

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MRFCoxAwardAubrey2

Identifier Type: -

Identifier Source: org_study_id

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