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Sponsored by: |
Aarhus University Hospital |
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Information provided by: | Aarhus University Hospital |
ClinicalTrials.gov Identifier: | NCT00835003 |
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: | Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Timing of Elective Caesarean Section and Neonatal Morbidity - a Randomised Multicentre Study |
Estimated Enrollment: | 1010 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
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)
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2: Active Comparator
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)
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Julie Glavind, MD | +45 51955559 | julie.glavind@ki.au.dk |
Contact: Niels Uldbjerg, MD,Professor | +45 89496315 | uldbjerg@ki.au.dk |
Denmark | |
Department of Obstetrics and Gynecology, Aarhus University Hospital Skejby | Recruiting |
Aarhus N, Denmark, 8200 | |
Contact: Julie Glavind, MD, PhDstudent 0045 51955559 julie.glavind@ki.au.dk | |
Regional Hospital of Randers | Not yet recruiting |
Randers, Denmark, 8930 | |
Hospital of Kolding | Recruiting |
Kolding, Denmark, 6000 | |
Aarhus University Hospital, Aalborg Hospital | Not yet recruiting |
Aalborg, Denmark, 9000 | |
Regional Hospital of Viborg | Not yet recruiting |
Viborg, Denmark, 8800 | |
Regional Hospital of Herning | Not yet recruiting |
Herning, Denmark, 7400 |
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, PhD | Neonatal Department, Aarhus University Hospital Skejby |
Study Chair: | Sara F Kindberg, PhD, midwife | Perinatal Research Unit, Aarhus University Hospital Skejby |
Responsible Party: | Department of Gynecology and Obstetrics, Aarhus University Hospital Skejby ( MD Julie Glavind ) |
Study ID Numbers: | AAUH091077 |
Study First Received: | February 2, 2009 |
Last Updated: | April 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00835003 History of Changes |
Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics; Denmark: Danish Dataprotection Agency |
Neonatal admission Elective Caesarean Section Timing |
Choice behavior Intraoperative complications Postoperative complications |
Respiratory Tract Diseases Postoperative Complications Respiration Disorders Intraoperative Complications |
Respiratory Tract Diseases Respiration Disorders |