Timing of Planned Caesarean Section and Morbidity of the Newborn

Overview

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.

Full Title of Study: “Timing of Elective Caesarean Section and Neonatal Morbidity – a Randomised Multicentre Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: November 2011

Interventions

  • Procedure: Elective caesarean section
    • Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)
  • Procedure: Elective caesarean section
    • Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)

Arms, Groups and Cohorts

  • Active Comparator: 1
    • Elective caesarean section at 38 weeks and 3 days of gestation
  • Active Comparator: 2
    • Elective caesarean section at 39 weeks and 3 days of gestation

Clinical Trial Outcome Measures

Primary Measures

  • Neonatal Admission After Elective Caesarean Section
    • Time Frame: 48 hours

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aarhus University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Julie Glavind, MD, PhD – Aarhus University Hospital
  • Overall Official(s)
    • Julie Glavind, MD, Principal Investigator, Department of Gynecology and Obstetrics, Aarhus University Hospital Skejby
    • Niels Uldbjerg, MD,Professor, Study Chair, Department og Gynecology and Obstetrics, Aarhus University Hospital Skejby
    • Tine B Henriksen, MD, Professor, Study Chair, Neonatal Department, Aarhus University Hospital Skejby
    • Sara F Kindberg, PhD, midwife, Study Chair, Perinatal Research Unit, Aarhus University Hospital Skejby

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