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Timing of Planned Caesarean Section and Morbidity of the Newborn

NCT00835003 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1273

Last updated 2014-07-03

Study results available
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Summary

The caesarean section rate is rising globally. About 10% of the newborns are submitted to a neonatal department after planned caesarean section, primarily with respiratory disorders. More children are submitted if caesarean is performed earlier in pregnancy.

Study hypothesis: More newborns are admitted after planned caesarean at 38 weeks and 3 days of gestation than after 39 weeks and 3 days of gestation.

Aim of study: To compare elective caesarean section performed at 38 weeks and 3 days of gestation with 39 weeks and 3 days of gestation. According to this timing to determine the proportion of newborns admitted within 48 hours after birth.

Conditions

Interventions

PROCEDURE

Elective caesarean section

Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)

PROCEDURE

Elective caesarean section

Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)

Sponsors & Collaborators

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Julie Glavind, MD · Department of Gynecology and Obstetrics, Aarhus University Hospital Skejby

  • Niels Uldbjerg, MD,Professor · Department og Gynecology and Obstetrics, Aarhus University Hospital Skejby

  • Tine B Henriksen, MD, Professor · Neonatal Department, Aarhus University Hospital Skejby

  • Sara F Kindberg, PhD, midwife · Perinatal Research Unit, Aarhus University Hospital Skejby

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-11-30
Completion
2014-03-31

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00835003 on ClinicalTrials.gov