Timing of Planned Caesarean Section and Morbidity of the Newborn

Study Overview
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Brief Summary
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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.

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

Conditions
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Respiratory Disorders, Intensive Care, Neonatal

Intervention / Treatment
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* Procedure: Elective caesarean section
* Procedure: Elective caesarean section


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Elective caesarean section at 38 weeks and 3 days of gestation | Procedure: Elective caesarean section<br>* Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)<br>* Other names: Planned caesarean section;|
| Active Comparator: 2<br>Elective caesarean section at 39 weeks and 3 days of gestation | Procedure: Elective caesarean section<br>* Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)<br>* Other names: Planned caesarean section;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal Admission After Elective Caesarean Section |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal Diagnoses |  | 30 days | 
| Duration of Neonatal Treatment With Ventilator, CPAP, Oxygen and/or Antibiotics |  | 30 days | 
| 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 | 
| Maternal Satisfaction With Timing of Elective Caesarean Section |  | 2 months | 
| Post Partum Depression |  | 2 months | 
| Pediatric Admission and Morbidity |  | 2 months post partum | 
| Pediatric Admission and Morbidity |  | From birth until 2 years of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neonatal admission, Elective Caesarean Section, Timing, Choice behavior, Intraoperative complications, Postoperative complications