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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Elective caesarean section at 38 weeks and 3 days of gestation |
|
| 2 | Active Comparator | Elective caesarean section at 39 weeks and 3 days of gestation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elective caesarean section | Procedure | Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Admission After Elective Caesarean Section | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Diagnoses | 30 days | |
| Duration of Neonatal Treatment With Ventilator, CPAP, Oxygen and/or Antibiotics | 30 days | |
| Maternal Haemorrhage in ml or Organ Laceration During Caesarean Section. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie Glavind, MD | Department of Gynecology and Obstetrics, Aarhus University Hospital Skejby | Principal Investigator |
| 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 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Odense | Odense | Odense | 5000 | Denmark | ||
| Aarhus University Hospital, Aalborg Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24376842 | Derived | 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. | |
| 23682628 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | 39 Weeks Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Neonatal Admission After Elective Caesarean Section | Posted | Number | participants | 48 hours |
|
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fetal death | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| MD, PhD Julie Glavind | Aarhus University Hospital, Dep. Obstetrics and Gynecology, Aarhus, Denmark | +4578450000 | julie.glavind@dadlnet.dk |
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| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D007431 | Intraoperative Complications |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017558 | Elective Surgical Procedures |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Elective caesarean section | Procedure | Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days) |
|
|
| 30 days |
| Maternal Fever, Wound Infection, Need of Wound Operative Revision and Antibiotics, Duration of Admission | 30 days |
| Maternal Satisfaction With Timing of Elective Caesarean Section | 2 months |
| Post Partum Depression | 2 months |
| Pediatric Admission and Morbidity | 2 months post partum |
| Pediatric Admission and Morbidity | From birth until 2 years of age |
| Aalborg |
| 9000 |
| Denmark |
| Department of Obstetrics and Gynecology, Aarhus University Hospital Skejby | Aarhus N | 8200 | Denmark |
| Regional Hospital of Herning | Herning | 7400 | Denmark |
| Hospital of Kolding | Kolding | 6000 | Denmark |
| Regional Hospital of Randers | Randers | 8930 | Denmark |
| Regional Hospital of Viborg | Viborg | 8800 | Denmark |
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)
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
|
| Secondary | Neonatal Diagnoses | Not Posted | 30 days |
| Secondary | Duration of Neonatal Treatment With Ventilator, CPAP, Oxygen and/or Antibiotics | Not Posted | 30 days |
| Secondary | Maternal Haemorrhage in ml or Organ Laceration During Caesarean Section. | Not Posted | 30 days |
| Secondary | Maternal Fever, Wound Infection, Need of Wound Operative Revision and Antibiotics, Duration of Admission | Not Posted | 30 days |
| Secondary | Maternal Satisfaction With Timing of Elective Caesarean Section | Not Posted | 2 months |
| Secondary | Post Partum Depression | Not Posted | 2 months |
| Secondary | Pediatric Admission and Morbidity | Not Posted | 2 months post partum |
| Secondary | Pediatric Admission and Morbidity | Not Posted | From birth until 2 years of age |
| 1 |
| 636 |
| 0 |
| 636 |
| EG001 | 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) | 2 | 638 | 0 | 638 |
| Neonatal death | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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