Timing of Planned Caesarean Section and Morbidity of the Newborn - Full Text View

Sponsor:	Aarhus University Hospital
Information provided by:	Aarhus University Hospital
ClinicalTrials.gov Identifier:	NCT00835003

Purpose

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.

Condition	Intervention
Respiratory Disorders Intensive Care, Neonatal	Procedure: Elective caesarean section

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Timing of Elective Caesarean Section and Neonatal Morbidity - a Randomised Multicentre Study

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section

U.S. FDA Resources

Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:

Neonatal admission after elective caesarean section [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Neonatal diagnoses [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Duration of neonatal treatment with ventilator, CPAP, oxygen and/or antibiotics [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Maternal haemorrhage in ml or organ laceration during caesarean section. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Maternal fever, wound infection, need of wound operative revision and antibiotics, duration of admission [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Maternal satisfaction with timing of elective caesarean section [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Post partum depression [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Pediatric admission and morbidity [ Time Frame: 2 months post partum ] [ Designated as safety issue: No ]
Pediatric admission and morbidity [ Time Frame: From birth until 2 years of age ] [ Designated as safety issue: No ]

Enrollment:	1273
Study Start Date:	March 2009
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Elective caesarean section at 38 weeks and 3 days of gestation	Procedure: Elective caesarean section Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days) Other Names: Elective surgery Planned caesarean section
Active Comparator: 2 Elective caesarean section at 39 weeks and 3 days of gestation	Procedure: Elective caesarean section Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days) Other Names: Elective surgery Planned caesarean section

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00835003

Locations

Denmark
Aarhus University Hospital, Aalborg Hospital
Aalborg, Denmark, 9000
Department of Obstetrics and Gynecology, Aarhus University Hospital Skejby
Aarhus N, Denmark, 8200
Regional Hospital of Herning
Herning, Denmark, 7400
Hospital of Kolding
Kolding, Denmark, 6000
University Hospital of Odense
Odense, Denmark, 5000
Regional Hospital of Randers
Randers, Denmark, 8930
Regional Hospital of Viborg
Viborg, Denmark, 8800

Sponsors and Collaborators

Aarhus University Hospital

Investigators

Principal Investigator:	Julie Glavind, MD	Department of Gynecology and Obstetrics, Aarhus University Hospital Skejby
Study Chair:	Niels Uldbjerg, MD,Professor	Department og Gynecology and Obstetrics, Aarhus University Hospital Skejby
Study Chair:	Tine B Henriksen, MD, Professor	Neonatal Department, Aarhus University Hospital Skejby
Study Chair:	Sara F Kindberg, PhD, midwife	Perinatal Research Unit, Aarhus University Hospital Skejby

More Information

No publications provided

Responsible Party:	MD Julie Glavind, Department of Gynecology and Obstetrics, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier:	NCT00835003 History of Changes
Other Study ID Numbers:	AAUH091077
Study First Received:	February 2, 2009
Last Updated:	June 15, 2011
Health Authority:	Denmark: The Regional Committee on Biomedical Research Ethics; Denmark: Danish Dataprotection Agency

Keywords provided by Aarhus University Hospital:

Neonatal admission
Elective Caesarean Section
Timing

Choice behavior
Intraoperative complications
Postoperative complications

Additional relevant MeSH terms:

Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 09, 2012