Intensive Care, Neonatal, Respiratory Disorders
Conditions
Keywords
Neonatal admission, Elective Caesarean Section, Timing, Choice behavior, Intraoperative complications, Postoperative complications
Brief 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.
Interventions
PROCEDUREElective caesarean section
Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)
Sponsors
Aarhus University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neonatal Admission After Elective Caesarean Section | 48 hours |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Neonatal Diagnoses | 30 days |
| Post Partum Depression | 2 months |
| Pediatric Admission and Morbidity | 2 months post partum |
| Maternal Satisfaction With Timing of Elective Caesarean Section | 2 months |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 38 Weeks Group Elective caesarean section at 38 weeks and 3 days of gestation
Elective caesarean section: Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days) | 636 |
| 39 Weeks Group Elective caesarean section at 39 weeks and 3 days of gestation
Elective caesarean section: Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days) | 638 |
| Total | 1,274 |
Baseline characteristics
| Characteristic | 38 Weeks Group | 39 Weeks Group | Total |
|---|---|---|---|
| Age, Continuous | 32.1 years STANDARD_DEVIATION 4.4 | 31.6 years STANDARD_DEVIATION 4.6 | 31.8 years STANDARD_DEVIATION 4 |
| Region of Enrollment Denmark | 636 participants | 638 participants | 1274 participants |
| Sex: Female, Male Female | 636 Participants | 638 Participants | 1274 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 636 | 0 / 638 |
| serious Total, serious adverse events | 1 / 636 | 2 / 638 |
Outcome results
Primary
Neonatal Admission After Elective Caesarean Section
Time frame: 48 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 38 Weeks Group | Neonatal Admission After Elective Caesarean Section | 88 participants |
| 39 Weeks Group | Neonatal Admission After Elective Caesarean Section | 76 participants |
p-value: 0.3195% CI: [0.65, 1.15]Chi-squared
Secondary
Duration of Neonatal Treatment With Ventilator, CPAP, Oxygen and/or Antibiotics
Time frame: 30 days
Secondary
Maternal Fever, Wound Infection, Need of Wound Operative Revision and Antibiotics, Duration of Admission
Time frame: 30 days
Secondary
Maternal Haemorrhage in ml or Organ Laceration During Caesarean Section.
Time frame: 30 days
Secondary
Maternal Satisfaction With Timing of Elective Caesarean Section
Time frame: 2 months
Secondary
Neonatal Diagnoses
Time frame: 30 days
Secondary
Pediatric Admission and Morbidity
Time frame: 2 months post partum
Secondary
Pediatric Admission and Morbidity
Time frame: From birth until 2 years of age
Secondary
Post Partum Depression
Time frame: 2 months