N/A
N=1,274
Timing of Planned Caesarean Section and Morbidity of the Newborn
Respiratory Disorders · Intensive Care, Neonatal
Bottom Line
View on ClinicalTrials.gov: NCT00835003 ↗Enrolled (actual)
1,274
Serious AEs
0.2%
Results posted
Jul 2014
Primary outcome: Primary: Neonatal Admission After Elective Caesarean Section — 88; 76 participants — p=0.31
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Elective caesarean section (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Aarhus University Hospital
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neonatal Admission After Elective Caesarean Section |
88; 76 | 0.31 |
| SECONDARY Neonatal Diagnoses |
— | — |
| SECONDARY Duration of Neonatal Treatment With Ventilator, CPAP, Oxygen and/or Antibiotics |
— | — |
| SECONDARY Maternal Haemorrhage in ml or Organ Laceration During Caesarean Section. |
— | — |
| SECONDARY Maternal Fever, Wound Infection, Need of Wound Operative Revision and Antibiotics, Duration of Admission |
— | — |
| SECONDARY Maternal Satisfaction With Timing of Elective Caesarean Section |
— | — |
| SECONDARY Post Partum Depression |
— | — |
| SECONDARY Pediatric Admission and Morbidity |
— | — |
| SECONDARY Pediatric Admission and Morbidity |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00835003). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.