Text Size

Timing of Planned Caesarean Section and Morbidity of the Newborn

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT00835003
First received: February 2, 2009
Last updated: June 15, 2011
Last verified: June 2011
History of Changes

February 2, 2009
June 15, 2011
March 2009
November 2011   (final data collection date for primary outcome measure)
Neonatal admission after elective caesarean section [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00835003 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Neonatal diagnoses [ Time Frame: 3 months ] [ 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: 1 hour ] [ 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 ]
  • Apgar score, neonatal acidosis at birth [ Time Frame: 1 min, 5 min, 10 min ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Timing of Planned Caesarean Section and Morbidity of the Newborn
Timing of Elective Caesarean Section and Neonatal Morbidity - a Randomised Multicentre Study

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Respiratory Disorders
  • Intensive Care, Neonatal
  • Procedure: Elective caesarean section
    Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)
    Other Names:
    • Elective surgery
    • Planned caesarean section
  • Procedure: Elective caesarean section
    Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)
    Other Names:
    • Elective surgery
    • Planned caesarean section
  • Active Comparator: 1
    Elective caesarean section at 38 weeks and 3 days of gestation
    Intervention: Procedure: Elective caesarean section
  • Active Comparator: 2
    Elective caesarean section at 39 weeks and 3 days of gestation
    Intervention: Procedure: Elective caesarean section
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1273
December 2013
November 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00835003
AAUH091077
Yes
MD Julie Glavind, Department of Gynecology and Obstetrics, Aarhus University Hospital Skejby
Aarhus University Hospital
Not Provided
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
Aarhus University Hospital
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP