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Timing of Planned Caesarean Section and Morbidity of the Newborn

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ClinicalTrials.gov Identifier: NCT00835003
Recruitment Status : Completed
First Posted : February 3, 2009
Results First Posted : July 3, 2014
Last Update Posted : July 3, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Respiratory Disorders Intensive Care, Neonatal Procedure: Elective caesarean section

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1273 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Timing of Elective Caesarean Section and Neonatal Morbidity - a Randomised Multicentre Study
Study Start Date : March 2009
Primary Completion Date : November 2011
Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Neonatal Admission After Elective Caesarean Section [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Neonatal Diagnoses [ Time Frame: 30 days ]
  2. Duration of Neonatal Treatment With Ventilator, CPAP, Oxygen and/or Antibiotics [ Time Frame: 30 days ]
  3. Maternal Haemorrhage in ml or Organ Laceration During Caesarean Section. [ Time Frame: 30 days ]
  4. Maternal Fever, Wound Infection, Need of Wound Operative Revision and Antibiotics, Duration of Admission [ Time Frame: 30 days ]
  5. Maternal Satisfaction With Timing of Elective Caesarean Section [ Time Frame: 2 months ]
  6. Post Partum Depression [ Time Frame: 2 months ]
  7. Pediatric Admission and Morbidity [ Time Frame: 2 months post partum ]
  8. Pediatric Admission and Morbidity [ Time Frame: From birth until 2 years of age ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: February 3, 2009    Key Record Dates
Results First Posted: July 3, 2014
Last Update Posted: July 3, 2014
Last Verified: June 2014

Keywords provided by Julie Glavind, Aarhus University Hospital:
Neonatal admission
Elective Caesarean Section
Timing
Choice behavior
Intraoperative complications
Postoperative complications

Additional relevant MeSH terms:
Respiration Disorders
Respiratory Tract Diseases