Timing of Planned Caesarean Section and Morbidity of the Newborn

Respiratory Disorders Clinical Trial

Official title:

Timing of Elective Caesarean Section and Neonatal Morbidity - a Randomised Multicentre Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00835003
• Other study ID #: AAUH091077
• Status: Completed
• Phase: N/A
• First received: February 2, 2009
• Last updated: June 3, 2014
• Start date: March 2009
• Est. completion date: March 2014

Study information

• Verified date: June 2014
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1273
• Est. completion date: March 2014
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Intensive Care, Neonatal
• Respiration Disorders
• Respiratory Disorders
• Respiratory Tract Diseases

Intervention

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

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Aalborg Hospital	Aalborg
Denmark	Department of Obstetrics and Gynecology, Aarhus University Hospital Skejby	Aarhus N
Denmark	Regional Hospital of Herning	Herning
Denmark	Hospital of Kolding	Kolding
Denmark	University Hospital of Odense	Odense
Denmark	Regional Hospital of Randers	Randers
Denmark	Regional Hospital of Viborg	Viborg

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal Admission After Elective Caesarean Section		48 hours	No
Secondary	Neonatal Diagnoses		30 days	No
Secondary	Duration of Neonatal Treatment With Ventilator, CPAP, Oxygen and/or Antibiotics		30 days	No
Secondary	Maternal Haemorrhage in ml or Organ Laceration During Caesarean Section.		30 days	No
Secondary	Maternal Fever, Wound Infection, Need of Wound Operative Revision and Antibiotics, Duration of Admission		30 days	No
Secondary	Maternal Satisfaction With Timing of Elective Caesarean Section		2 months	No
Secondary	Post Partum Depression		2 months	No
Secondary	Pediatric Admission and Morbidity		2 months post partum	No
Secondary	Pediatric Admission and Morbidity		From birth until 2 years of age	No