Timing of Planned Caesarean Section and Morbidity of the Newborn

• ClinicalTrials.gov Identifier: NCT00835003
• Recruitment Status: Completed
• First Posted: February 3, 2009
• Results First Posted: July 3, 2014
• Last Update Posted: July 3, 2014
• Sponsor: Aarhus University Hospital
• Information provided by (Responsible Party): Julie Glavind, Aarhus University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Respiratory Disorders; Intensive Care, Neonatal	Procedure: Elective caesarean section	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1273 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Timing of Elective Caesarean Section and Neonatal Morbidity - a Randomised Multicentre Study
• Study Start Date: March 2009
• Actual Primary Completion Date: November 2011
• Actual Study Completion Date: March 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1; Elective caesarean section at 38 weeks and 3 days of gestation	Procedure: Elective caesarean section; Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days); Other Names: Elective surgery; Planned caesarean section
Active Comparator: 2; Elective caesarean section at 39 weeks and 3 days of gestation	Procedure: Elective caesarean section; Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days); Other Names: Elective surgery; Planned caesarean section

Outcome Measures

Primary Outcome Measures :

1. Neonatal Admission After Elective Caesarean Section [ Time Frame: 48 hours ]

Secondary Outcome Measures :

1. Neonatal Diagnoses [ Time Frame: 30 days ]
2. Duration of Neonatal Treatment With Ventilator, CPAP, Oxygen and/or Antibiotics [ Time Frame: 30 days ]
3. Maternal Haemorrhage in ml or Organ Laceration During Caesarean Section. [ Time Frame: 30 days ]
4. Maternal Fever, Wound Infection, Need of Wound Operative Revision and Antibiotics, Duration of Admission [ Time Frame: 30 days ]
5. Maternal Satisfaction With Timing of Elective Caesarean Section [ Time Frame: 2 months ]
6. Post Partum Depression [ Time Frame: 2 months ]
7. Pediatric Admission and Morbidity [ Time Frame: 2 months post partum ]
8. Pediatric Admission and Morbidity [ Time Frame: From birth until 2 years of age ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Denmark

Aarhus University Hospital, Aalborg Hospital

Aalborg, Denmark, 9000

Department of Obstetrics and Gynecology, Aarhus University Hospital Skejby

Aarhus N, Denmark, 8200

Regional Hospital of Herning

Herning, Denmark, 7400

Hospital of Kolding

Kolding, Denmark, 6000

University Hospital of Odense

Odense, Denmark, 5000

Regional Hospital of Randers

Randers, Denmark, 8930

Regional Hospital of Viborg

Viborg, Denmark, 8800

Sponsors and Collaborators

Aarhus University Hospital

Investigators

• Principal Investigator: Julie Glavind, MD; Department of Gynecology and Obstetrics, Aarhus University Hospital Skejby
• Study Chair: Niels Uldbjerg, MD,Professor; Department og Gynecology and Obstetrics, Aarhus University Hospital Skejby
• Study Chair: Tine B Henriksen, MD, Professor; Neonatal Department, Aarhus University Hospital Skejby
• Study Chair: Sara F Kindberg, PhD, midwife; Perinatal Research Unit, Aarhus University Hospital Skejby

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Glavind J, Kindberg SF, Uldbjerg N, Khalil M, Møller AM, Mortensen BB, Rasmussen OB, Christensen JT, Jørgensen 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.

• Responsible Party: Julie Glavind, MD, PhD, Aarhus University Hospital
• ClinicalTrials.gov Identifier: NCT00835003
• Other Study ID Numbers: AAUH091077
• First Posted: February 3, 2009
• Results First Posted: July 3, 2014
• Last Update Posted: July 3, 2014
• Last Verified: June 2014

Keywords provided by Julie Glavind, Aarhus University Hospital:

Neonatal admission; Elective Caesarean Section; Timing; Choice behavior; Intraoperative complications; Postoperative complications

Additional relevant MeSH terms:

Respiration Disorders; Respiratory Tract Diseases