Timing of Planned Caesarean Section and Morbidity of the Newborn

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Julie Glavind, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT00835003
First received: February 2, 2009
Last updated: June 3, 2014
Last verified: June 2014
  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:


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
Study Completion Date: March 2014
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Aarhus University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Julie Glavind, MD, PhD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00835003     History of Changes
Other Study ID Numbers: AAUH091077
Study First Received: February 2, 2009
Results First Received: June 3, 2014
Last Updated: June 3, 2014
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 October 20, 2014