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CompletedNCT02866058Updated Aug 15, 2016

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

An observational study in Pregnancy Complications and Cesarean Section, sponsored by Memorial University of Newfoundland. Completed. Per ClinicalTrials.gov, last updated 2016-08-15.

Sponsored by Memorial University of Newfoundland · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,703,590
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Pregnancy Complications
  • Cesarean Section
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In context

Pregnancy Complications

437 studies on the registry are indexed under Pregnancy Complications; 119 are open to participants now.

This study's enrollment of 1,703,590 is above the median of 320 across 205 observational studies indexed under Pregnancy Complications.

Browse Pregnancy Complications studies →

Lead sponsor

Memorial University of Newfoundland is the lead sponsor of 46 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
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

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

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,703,590 participants (actual)
Patient registry
No

Groups and cohorts

  • Cesarean

    Mothers delivered by cesarean section

    Procedure: Cesarean Section

  • Vaginal

    Mothers delivered by vaginal delivery

Interventions

  • ProcedureCesarean Section
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What researchers measure

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.

    Time frame: up to 7 days

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No — The data provider does not allow sharing of investigator data, but data can be requested directly from them.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02866058
Lead sponsor
Memorial University of Newfoundland
Collaborators
Medical Research Foundation - Memorial University
Responsible party
Kris Aubrey-Bassler (Director, Primary Healthcare Research Unit, Memorial University of Newfoundland) — Principal investigator
First posted
Aug 15, 2016
Start date
May 2011
Primary completion
Jul 2013
Completion
Jul 2015
Last update
Aug 15, 2016

Study contacts

Kris Aubrey-Bassler, MD
principal investigator · Memorial University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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