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Timing of Planned Caesarean Section and Morbidity of the Newborn

Primary Purpose

Respiratory Disorders, Intensive Care, Neonatal

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Elective caesarean section
Elective caesarean section
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Disorders focused on measuring Neonatal admission, Elective Caesarean Section, Timing, Choice behavior, Intraoperative complications, Postoperative complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus University Hospital, Aalborg Hospital
  • Department of Obstetrics and Gynecology, Aarhus University Hospital Skejby
  • Regional Hospital of Herning
  • Hospital of Kolding
  • University Hospital of Odense
  • Regional Hospital of Randers
  • Regional Hospital of Viborg

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Elective caesarean section at 38 weeks and 3 days of gestation

Elective caesarean section at 39 weeks and 3 days of gestation

Outcomes

Primary Outcome Measures

Neonatal Admission After Elective Caesarean Section

Secondary Outcome Measures

Neonatal Diagnoses
Duration of Neonatal Treatment With Ventilator, CPAP, Oxygen and/or Antibiotics
Maternal Haemorrhage in ml or Organ Laceration During Caesarean Section.
Maternal Fever, Wound Infection, Need of Wound Operative Revision and Antibiotics, Duration of Admission
Maternal Satisfaction With Timing of Elective Caesarean Section
Post Partum Depression
Pediatric Admission and Morbidity
Pediatric Admission and Morbidity

Full Information

First Posted
February 2, 2009
Last Updated
June 3, 2014
Sponsor
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00835003
Brief Title
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

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Disorders, Intensive Care, Neonatal
Keywords
Neonatal admission, Elective Caesarean Section, Timing, Choice behavior, Intraoperative complications, Postoperative complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1273 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Elective caesarean section at 38 weeks and 3 days of gestation
Arm Title
2
Arm Type
Active Comparator
Arm Description
Elective caesarean section at 39 weeks and 3 days of gestation
Intervention Type
Procedure
Intervention Name(s)
Elective caesarean section
Other Intervention Name(s)
Elective surgery, Planned caesarean section
Intervention Description
Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)
Intervention Type
Procedure
Intervention Name(s)
Elective caesarean section
Other Intervention Name(s)
Elective surgery, Planned caesarean section
Intervention Description
Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)
Primary Outcome Measure Information:
Title
Neonatal Admission After Elective Caesarean Section
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Neonatal Diagnoses
Time Frame
30 days
Title
Duration of Neonatal Treatment With Ventilator, CPAP, Oxygen and/or Antibiotics
Time Frame
30 days
Title
Maternal Haemorrhage in ml or Organ Laceration During Caesarean Section.
Time Frame
30 days
Title
Maternal Fever, Wound Infection, Need of Wound Operative Revision and Antibiotics, Duration of Admission
Time Frame
30 days
Title
Maternal Satisfaction With Timing of Elective Caesarean Section
Time Frame
2 months
Title
Post Partum Depression
Time Frame
2 months
Title
Pediatric Admission and Morbidity
Time Frame
2 months post partum
Title
Pediatric Admission and Morbidity
Time Frame
From birth until 2 years of age

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Glavind, MD
Organizational Affiliation
Department of Gynecology and Obstetrics, Aarhus University Hospital Skejby
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Niels Uldbjerg, MD,Professor
Organizational Affiliation
Department og Gynecology and Obstetrics, Aarhus University Hospital Skejby
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tine B Henriksen, MD, Professor
Organizational Affiliation
Neonatal Department, Aarhus University Hospital Skejby
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sara F Kindberg, PhD, midwife
Organizational Affiliation
Perinatal Research Unit, Aarhus University Hospital Skejby
Official's Role
Study Chair
Facility Information:
Facility Name
Aarhus University Hospital, Aalborg Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Department of Obstetrics and Gynecology, Aarhus University Hospital Skejby
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Regional Hospital of Herning
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Hospital of Kolding
City
Kolding
ZIP/Postal Code
6000
Country
Denmark
Facility Name
University Hospital of Odense
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Regional Hospital of Randers
City
Randers
ZIP/Postal Code
8930
Country
Denmark
Facility Name
Regional Hospital of Viborg
City
Viborg
ZIP/Postal Code
8800
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
24376842
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.
Results Reference
derived
PubMed Identifier
23682628
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.
Results Reference
derived

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Timing of Planned Caesarean Section and Morbidity of the Newborn

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