Timing of Planned Caesarean Section and Morbidity of the Newborn

Aarhus University Hospital

Status: Completed

Conditions: Intensive Care, Neonatal; Respiratory Disorders

Treatments: Procedure: Elective caesarean section

Study type: Interventional

Funder types: Other

Identifiers

NCT00835003

AAUH091077

Details and patient eligibility

About

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.

Enrollment: 1,273 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,273 participants in 2 patient groups

1

Active Comparator group

Description:

Elective caesarean section at 38 weeks and 3 days of gestation

Treatment:

Procedure: Elective caesarean section

Procedure: Elective caesarean section

2

Active Comparator group

Description:

Elective caesarean section at 39 weeks and 3 days of gestation

Treatment:

Procedure: Elective caesarean section

Procedure: Elective caesarean section