Clinical trial NCT00835003: Timing of Planned Caesarean Section and Morbidity of the Newborn
Official title: Timing of Elective Caesarean Section and Neonatal Morbidity - a Randomised Multicentre Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Disorders
Intensive Care, Neonatal
Keywords: Neonatal admission
Elective Caesarean Section
Timing
Choice behavior
Intraoperative complications
Postoperative complications
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2009-02-03
Enrollment: 1273
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Neonatal Admission After Elective Caesarean Section
timeFrame: 48 hours
Secondary outcomes:
measure: Neonatal Diagnoses
timeFrame: 30 days
measure: Duration of Neonatal Treatment With Ventilator, CPAP, Oxygen and/or Antibiotics
timeFrame: 30 days
measure: Maternal Haemorrhage in ml or Organ Laceration During Caesarean Section.
timeFrame: 30 days
measure: Maternal Fever, Wound Infection, Need of Wound Operative Revision and Antibiotics, Duration of Admission
timeFrame: 30 days
measure: Maternal Satisfaction With Timing of Elective Caesarean Section
timeFrame: 2 months
measure: Post Partum Depression
timeFrame: 2 months
measure: Pediatric Admission and Morbidity
timeFrame: 2 months post partum
measure: Pediatric Admission and Morbidity
timeFrame: From birth until 2 years of age
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aarhus University Hospital, Aalborg Hospital
city: Aarhus N
country: Denmark
facility: Department of Obstetrics and Gynecology, Aarhus University Hospital Skejby
city: Herning
country: Denmark
facility: Regional Hospital of Herning
city: Kolding
country: Denmark
facility: Hospital of Kolding
city: Odense
country: Denmark
facility: University Hospital of Odense
city: Randers
country: Denmark
facility: Regional Hospital of Randers
city: Viborg
country: Denmark
facility: Regional Hospital of Viborg
Study officials:
affiliation: Department of Gynecology and Obstetrics, Aarhus University Hospital Skejby
name: Julie Glavind, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department og Gynecology and Obstetrics, Aarhus University Hospital Skejby
name: Niels Uldbjerg, MD,Professor
role: STUDY_CHAIR
affiliation: Neonatal Department, Aarhus University Hospital Skejby
name: Tine B Henriksen, MD, Professor
role: STUDY_CHAIR
affiliation: Perinatal Research Unit, Aarhus University Hospital Skejby
name: Sara F Kindberg, PhD, midwife
role: STUDY_CHAIR
References:
citation: Glavind J, Henriksen TB, Kindberg SF, Uldbjerg N. Randomised trial of planned caesarean section prior to versus after 39 weeks: unscheduled deliveries and facility logistics--a secondary analysis. PLoS One. 2013 Dec 20;8(12):e84744. doi: 10.1371/journal.pone.0084744. eCollection 2013.
citation: Glavind J, Kindberg SF, Uldbjerg N, Khalil M, Moller AM, Mortensen BB, Rasmussen OB, Christensen JT, Jorgensen JS, Henriksen TB. Elective caesarean section at 38 weeks versus 39 weeks: neonatal and maternal outcomes in a randomised controlled trial. BJOG. 2013 Aug;120(9):1123-32. doi: 10.1111/1471-0528.12278. Epub 2013 May 20.