Respiratory DisordersNCT00835003
Timing of Planned Caesarean Section and Morbidity of the Newborn
A study testing Elective caesarean section in people with Respiratory Disorders and Intensive Care, Neonatal, run by Aarhus University Hospital at 7 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Respiratory Disorders, Intensive Care, Neonatal
- What is being tested?
- Elective caesarean section
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,273 participants
- Where
- 7 sitesDenmark
- Study dates
- Mar 2009to Mar 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective caesarean section
- Gestational age determined at 12 weeks ultrasound scan
- Singleton pregnancy
Who cannot join
- < 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Denmark7 sites
Aarhus University Hospital, Aalborg Hospital
Aalborg, 9000
Department of Obstetrics and Gynecology, Aarhus University Hospital Skejby
Aarhus N, 8200
Regional Hospital of Herning
Herning, 7400
Hospital of Kolding
Kolding, 6000
University Hospital of Odense
Odense, Odense, 5000
Regional Hospital of Randers
Randers, 8930
Regional Hospital of Viborg
Viborg, 8800
About this study
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.
- Conditions
- Respiratory Disorders, Intensive Care, Neonatal
- Being tested
- Elective caesarean section
- Keywords
- Neonatal admission, Elective Caesarean Section, Timing, Choice behavior, Intraoperative complications, Postoperative complications
- Medical subject headings
- Respiration Disorders, Intraoperative Complications, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective caesarean sectionProcedure or surgery
Also called Elective surgery, Planned caesarean section
Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)
Elective caesarean sectionProcedure or surgery
Also called Elective surgery, Planned caesarean section
Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Elective caesarean section at 38 weeks and 3 days of gestation Receives: Procedure: Elective caesarean section |
| 2 | Active comparator | Elective caesarean section at 39 weeks and 3 days of gestation Receives: Procedure: Elective caesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Admission After Elective Caesarean Section
Measured: 48 hours
Secondary outcomes (8)
Neonatal Diagnoses
Measured: 30 days
Duration of Neonatal Treatment With Ventilator, CPAP, Oxygen and/or Antibiotics
Measured: 30 days
Maternal Haemorrhage in ml or Organ Laceration During Caesarean Section.
Measured: 30 days
Maternal Fever, Wound Infection, Need of Wound Operative Revision and Antibiotics, Duration of Admission
Measured: 30 days
Maternal Satisfaction With Timing of Elective Caesarean Section
Measured: 2 months
Post Partum Depression
Measured: 2 months
Pediatric Admission and Morbidity
Measured: 2 months post partum
Pediatric Admission and Morbidity
Measured: From birth until 2 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionNov 2011
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory DisordersStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Glavind, Aarhus University Hospital
- Investigators
- Julie Glavind, MD, Principal investigator, Department of Gynecology and Obstetrics, Aarhus University Hospital SkejbyNiels Uldbjerg, MD,Professor, Study chair, Department og Gynecology and Obstetrics, Aarhus University Hospital SkejbyTine B Henriksen, MD, Professor, Study chair, Neonatal Department, Aarhus University Hospital SkejbySara F Kindberg, PhD, midwife, Study chair, Perinatal Research Unit, Aarhus University Hospital Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00835003
- Sponsor's protocol ID
- AAUH091077
- Status last verified
- Jun 2014
- First submitted
- 2 Feb 2009
- Last updated
- 3 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 24376842Glavind 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.
PubMed 23682628
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Elective Caesarean Section and Neonatal Morbidity - a Randomised Multicentre Study
- ClinicalTrials.gov ID
- NCT00835003
- Acronym / sponsor ID
- AAUH091077
- Conditions
- Respiratory Disorders, Intensive Care, Neonatal
- Keywords
- Neonatal admission, Elective Caesarean Section, Timing, Choice behavior, Intraoperative complications, Postoperative complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,273 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 3 Feb 2009 (estimated)
- Results
- Posted 3 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Elective caesarean sectionElective caesarean section at 38 weeks and 3 days of gestation |
| 2 | Active comparator | Procedure: Elective caesarean sectionElective caesarean section at 39 weeks and 3 days of gestation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective caesarean section
- Gestational age determined at 12 weeks ultrasound scan
- Singleton pregnancy
Key exclusion criteria (4 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elective caesarean sectionAlso: Elective surgery, Planned caesarean sectionProcedure performed at 38 weeks and 3 days of gestation (+/- 2 days) | Procedure or surgery | 1 |
| Elective caesarean sectionAlso: Elective surgery, Planned caesarean sectionProcedure performed at 39 weeks and 3 days of gestation (+/- 2 days) | Procedure or surgery | 2 |
Primary outcome
Neonatal Admission After Elective Caesarean Section
Time frame: 48 hours
8 secondary outcomes
Neonatal Diagnoses
Time frame: 30 days
Duration of Neonatal Treatment With Ventilator, CPAP, Oxygen and/or Antibiotics
Time frame: 30 days
Maternal Haemorrhage in ml or Organ Laceration During Caesarean Section.
Time frame: 30 days
Maternal Fever, Wound Infection, Need of Wound Operative Revision and Antibiotics, Duration of Admission
Time frame: 30 days
Maternal Satisfaction With Timing of Elective Caesarean Section
Time frame: 2 months
Post Partum Depression
Time frame: 2 months
Pediatric Admission and Morbidity
Time frame: 2 months post partum
Pediatric Admission and Morbidity
Time frame: From birth until 2 years of age
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24376842Glavind 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.
- Derived from this study: PubMed 23682628Glavind 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.
Related trials for Respiratory Disorders
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Glavind, MD principal investigator
Department of Gynecology and Obstetrics, Aarhus University Hospital Skejby
Niels Uldbjerg, MD,Professor study chair
Department og Gynecology and Obstetrics, Aarhus University Hospital Skejby
Tine B Henriksen, MD, Professor study chair
Neonatal Department, Aarhus University Hospital Skejby
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elective caesarean section in people with Respiratory Disorders and Intensive Care, Neonatal, run by Aarhus University Hospital at 7 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Admission After Elective Caesarean Section (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00835003, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2014.