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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00835003
Other study ID # AAUH091077
Secondary ID
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


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
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