Timing of Planned Caesarean Section and Morbidity of the Newborn
NCT ID: NCT00835003
Last Updated: 2014-07-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
1273 participants
INTERVENTIONAL
2009-03-31
2014-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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1
Elective caesarean section at 38 weeks and 3 days of gestation
Elective caesarean section
Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)
2
Elective caesarean section at 39 weeks and 3 days of gestation
Elective caesarean section
Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)
Interventions
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Elective caesarean section
Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)
Elective caesarean section
Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Gestational age determined at 12 weeks ultrasound scan
* Singleton pregnancy
Exclusion Criteria
* In need of an interpreter to communicate in danish
* Diabetes, both gestational and before pregnancy
* A mother with an estimated high risk of caesarean section before 39+5 weeks
18 Years
FEMALE
No
Sponsors
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Aarhus University Hospital
OTHER
Responsible Party
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Julie Glavind
MD, PhD
Principal Investigators
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Julie Glavind, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Gynecology and Obstetrics, Aarhus University Hospital Skejby
Niels Uldbjerg, MD,Professor
Role: STUDY_CHAIR
Department og Gynecology and Obstetrics, Aarhus University Hospital Skejby
Tine B Henriksen, MD, Professor
Role: STUDY_CHAIR
Neonatal Department, Aarhus University Hospital Skejby
Sara F Kindberg, PhD, midwife
Role: STUDY_CHAIR
Perinatal Research Unit, Aarhus University Hospital Skejby
Locations
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University Hospital of Odense
Odense, Odense, Denmark
Aarhus University Hospital, Aalborg Hospital
Aalborg, , Denmark
Department of Obstetrics and Gynecology, Aarhus University Hospital Skejby
Aarhus N, , Denmark
Regional Hospital of Herning
Herning, , Denmark
Hospital of Kolding
Kolding, , Denmark
Regional Hospital of Randers
Randers, , Denmark
Regional Hospital of Viborg
Viborg, , Denmark
Countries
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References
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Glavind J, Henriksen TB, Kindberg SF, Uldbjerg N. Randomised trial of planned caesarean section prior to versus after 39 weeks: unscheduled deliveries and facility logistics--a secondary analysis. PLoS One. 2013 Dec 20;8(12):e84744. doi: 10.1371/journal.pone.0084744. eCollection 2013.
Glavind J, Kindberg SF, Uldbjerg N, Khalil M, Moller AM, Mortensen BB, Rasmussen OB, Christensen JT, Jorgensen JS, Henriksen TB. Elective caesarean section at 38 weeks versus 39 weeks: neonatal and maternal outcomes in a randomised controlled trial. BJOG. 2013 Aug;120(9):1123-32. doi: 10.1111/1471-0528.12278. Epub 2013 May 20.
Other Identifiers
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AAUH091077
Identifier Type: -
Identifier Source: org_study_id
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