Respiratory Disorders Clinical Trial
Official title:
Timing of Elective Caesarean Section and Neonatal Morbidity - a Randomised Multicentre Study
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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 |
Lead Sponsor | Collaborator |
---|---|
Aarhus University Hospital |
Denmark,
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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