Timing of Planned Caesarean Section and Morbidity of the Newborn
Timing of Elective Caesarean Section and Neonatal Morbidity - a Randomised Multicentre Study
1 other identifier
interventional
1,273
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2009
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2009
CompletedFirst Posted
Study publicly available on registry
February 3, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedResults Posted
Study results publicly available
July 3, 2014
CompletedJuly 3, 2014
June 1, 2014
2.7 years
February 2, 2009
June 3, 2014
June 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neonatal Admission After Elective Caesarean Section
48 hours
Secondary Outcomes (8)
Neonatal Diagnoses
30 days
Duration of Neonatal Treatment With Ventilator, CPAP, Oxygen and/or Antibiotics
30 days
Maternal Haemorrhage in ml or Organ Laceration During Caesarean Section.
30 days
Maternal Fever, Wound Infection, Need of Wound Operative Revision and Antibiotics, Duration of Admission
30 days
Maternal Satisfaction With Timing of Elective Caesarean Section
2 months
- +3 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATORElective caesarean section at 38 weeks and 3 days of gestation
2
ACTIVE COMPARATORElective caesarean section at 39 weeks and 3 days of gestation
Interventions
Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)
Eligibility Criteria
You may qualify if:
- Elective caesarean section
- Gestational age determined at 12 weeks ultrasound scan
- Singleton pregnancy
You may not qualify if:
- \< 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
University Hospital of Odense
Odense, Odense, 5000, Denmark
Aarhus University Hospital, Aalborg Hospital
Aalborg, 9000, Denmark
Department of Obstetrics and Gynecology, Aarhus University Hospital Skejby
Aarhus N, 8200, Denmark
Regional Hospital of Herning
Herning, 7400, Denmark
Hospital of Kolding
Kolding, 6000, Denmark
Regional Hospital of Randers
Randers, 8930, Denmark
Regional Hospital of Viborg
Viborg, 8800, Denmark
Related Publications (2)
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.
PMID: 24376842DERIVEDGlavind 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.
PMID: 23682628DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- MD, PhD Julie Glavind
- Organization
- Aarhus University Hospital, Dep. Obstetrics and Gynecology, Aarhus, Denmark
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
February 2, 2009
First Posted
February 3, 2009
Study Start
March 1, 2009
Primary Completion
November 1, 2011
Study Completion
March 1, 2014
Last Updated
July 3, 2014
Results First Posted
July 3, 2014
Record last verified: 2014-06