Timing of Planned Caesarean Section and Morbidity of the Newborn

Not Applicable

Completed

• Conditions: Respiratory Disorders; Intensive Care, Neonatal
• Interventions: Procedure: Elective caesarean section

• Registration Number: NCT00835003
• Lead Sponsor: Aarhus University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-02
• Study First Submitted QC: 2009-02-02
• Study First Posted: 2009-02-03
• Study Start: 2009-03
• Primary Completion: 2011-11
• Study Completion: 2014-03
• Status Verified: 2014-06
• Results First Submitted: 2014-06-03
• Results First Submitted QC: 2014-06-03
• Last Update Submitted: 2014-06-03
• Results First Posted: 2014-07-03
• Last Update Posted: 2014-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1273

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Elective caesarean section	Elective caesarean section at 38 weeks and 3 days of gestation
2	Elective caesarean section	Elective caesarean section at 39 weeks and 3 days of gestation

Primary Outcome Measures

Name	Time	Method
Neonatal Admission After Elective Caesarean Section	48 hours

Secondary Outcome Measures

Name	Time	Method
Maternal Satisfaction With Timing of Elective Caesarean Section	2 months
Neonatal Diagnoses	30 days
Duration of Neonatal Treatment With Ventilator, CPAP, Oxygen and/or Antibiotics	30 days
Post Partum Depression	2 months
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
Pediatric Admission and Morbidity	From birth until 2 years of age

Trial Locations

Locations (7)

Department of Obstetrics and Gynecology, Aarhus University Hospital Skejby; 🇩🇰 Aarhus N, Denmark

University Hospital of Odense; 🇩🇰 Odense, Denmark

Regional Hospital of Herning; 🇩🇰 Herning, Denmark

Hospital of Kolding; 🇩🇰 Kolding, Denmark

Regional Hospital of Randers; 🇩🇰 Randers, Denmark

Regional Hospital of Viborg; 🇩🇰 Viborg, Denmark

Aarhus University Hospital, Aalborg Hospital; 🇩🇰 Aalborg, Denmark