Timing of Planned Caesarean Section and Morbidity of the Newborn

NCT ID: NCT00835003

Last Updated: 2014-07-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1273 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Disorders Intensive Care, Neonatal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Elective caesarean section at 38 weeks and 3 days of gestation

Group Type ACTIVE_COMPARATOR

Elective caesarean section

Intervention Type PROCEDURE

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

2

Elective caesarean section at 39 weeks and 3 days of gestation

Group Type ACTIVE_COMPARATOR

Elective caesarean section

Intervention Type PROCEDURE

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)

Intervention Type PROCEDURE

Elective caesarean section

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

Intervention Type PROCEDURE

Other Intervention Names

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Elective surgery Planned caesarean section Elective surgery Planned caesarean section

Eligibility Criteria

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Inclusion Criteria

* Elective caesarean section
* Gestational age determined at 12 weeks ultrasound scan
* Singleton pregnancy

Exclusion Criteria

* \< 18 years of age (at time of randomization)
* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Julie Glavind

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Aarhus University Hospital, Aalborg Hospital

Aalborg, , Denmark

Site Status

Department of Obstetrics and Gynecology, Aarhus University Hospital Skejby

Aarhus N, , Denmark

Site Status

Regional Hospital of Herning

Herning, , Denmark

Site Status

Hospital of Kolding

Kolding, , Denmark

Site Status

Regional Hospital of Randers

Randers, , Denmark

Site Status

Regional Hospital of Viborg

Viborg, , Denmark

Site Status

Countries

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Denmark

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.

Reference Type DERIVED
PMID: 24376842 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23682628 (View on PubMed)

Other Identifiers

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AAUH091077

Identifier Type: -

Identifier Source: org_study_id

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