Breech PresentationNCT00141687
Early External Cephalic Version (ECV) 2 Trial
A study testing Early ECV between 34 0/7 and 35 6/7 weeks and Delayed ECV at or after 37 0/7 weeks in people with Breech Presentation, run by McMaster University at 1 site in Canada.
Trial summary
For women with a fetus in breech presentation, does early ECV (at 34 0/7 up to 35 weeks and 6/7 days) versus delayed ECV (not before 37 weeks and 0/7 days) increase or decrease the likelihood of cesarean section (CS)? Read more about this study
- Who is it for?
- Ages 14 to 45 years, women only
- Conditions the study is for
- Breech Presentation
- What is being tested?
- Early ECV between 34 0/7 and 35 6/7 weeks and Delayed ECV at or after 37 0/7 weeks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,543 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2004to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Women with any breech presentation
- A live singleton fetus
- Gestational age of 33 weeks 0 days to 35 weeks 6 days
Who cannot join
- Contraindications to ECV (e.g. fetal heart rate abnormalities, abruptio placenta, major life-threatening fetal anomalies, uterine anomalies, hyper-extended fetal head, rupture of membranes, severe oligohydramnios, severe polyhydramnios)
- Contraindications to early ECV (e.g. increased risk of preterm labour [such as past history of preterm labour in this or previous pregnancies], increased risk of abruptio placenta [such as maternal hypertension])
- Contraindications to labour or vaginal delivery (e.g. placenta previa, previous classical CS)
- Women planning delivery by CS if the fetus turns to cephalic
- Women planning a vaginal delivery if the fetus remains breech
- Women at increased risk of unstable lie (eg. grand multiparity)
- Previous participation in EECV2 Trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early External Cephalic Version 2 Trial
For women with a fetus in breech presentation, does early ECV (at 34 0/7 up to 35 weeks and 6/7 days) versus delayed ECV (not before 37 weeks and 0/7 days) increase or decrease the likelihood of cesarean section (CS)?
Read the detailed description
Primary Outcomes: Rate of Caesarean section
Secondary Outcomes: Rate of preterm birth
Other Outcomes: admission to neonatal intensive care unit ≥ 24 hours, perinatal or neonatal mortality or serious neonatal morbidity, serious fetal complications, maternal death or serious maternal morbidity, non-cephalic presentation at birth, women's views, and health care costs.
The Data Coordination for this study is being carried out at the Maternal, Infant Reproductive Health Research Unit at Sunnybrook and Women's College Health Sciences Centre.
- Conditions
- Breech Presentation
- Being tested
- Early ECV between 34 0/7 and 35 6/7 weeks, Delayed ECV at or after 37 0/7 weeks
- Keywords
- External cephalic version, Cesarean section, pregnancy, labour, Breech pregnancy
- Medical subject headings
- Breech Presentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early ECV between 34 0/7 and 35 6/7 weeksProcedure or surgery
Also called Early External Cephalic Version (ECV)
Early external cephalic version between 34 0/7 and 35 6/7 weeks of gestation
Delayed ECV at or after 37 0/7 weeksProcedure or surgery
Also called Delayed External Cephalic Version (ECV)
Delayed external cephalic version at or after 37 0/7 weeks of gestation
| Study group | Role | What they receive |
|---|---|---|
| Early External Cephalic Version Group | Experimental | Early external cephalic version (ECV) procedure performed between 34 weeks and 0/7 days and 35 weeks and 6/7 days of gestation Receives: Procedure: Early ECV between 34 0/7 and 35 6/7 weeks |
| Delayed External Cephalic Version Group | Active comparator | Delayed external cephalic version (ECV) procedure performed at or after 37 weeks and 0/7 days of gestation Receives: Procedure: Delayed ECV at or after 37 0/7 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of cesarean section
Measured: Information not available
Secondary outcomes (1)
Rate of pre-term births. Other outcomes: admission to neonatal intensive care unit ≥ 24 hours, perinatal or neonatal mortality or serious neonatal morbidity, or others.
Measured: Information not available
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breech PresentationStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 1,543 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of British Columbia
- Responsible party
- Principal investigator, Eileen Hutton, McMaster University
- Investigators
- Dr. Eileen Hutton, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141687
- Sponsor's protocol ID
- C04-0348
- Other IDs
- ISRCTN56498577
- Status last verified
- Sep 2016
- First submitted
- 30 Aug 2005
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early External Cephalic Version 2 Trial
- ClinicalTrials.gov ID
- NCT00141687
- Acronym / sponsor ID
- C04-0348
- Conditions
- Breech Presentation
- Keywords
- External cephalic version, Cesarean section, pregnancy, labour, Breech pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,543 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of British Columbia
- Study start
- Dec 2004
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 1 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For women with a fetus in breech presentation, does early ECV (at 34 0/7 up to 35 weeks and 6/7 days) versus delayed ECV (not before 37 weeks and 0/7 days) increase or decrease the likelihood of cesarean section (CS)?
Detailed description
Primary Outcomes: Rate of Caesarean section
Secondary Outcomes: Rate of preterm birth
Other Outcomes: admission to neonatal intensive care unit ≥ 24 hours, perinatal or neonatal mortality or serious neonatal morbidity, serious fetal complications, maternal death or serious maternal morbidity, non-cephalic presentation at birth, women's views, and health care costs.
The Data Coordination for this study is being carried out at the Maternal, Infant Reproductive Health Research Unit at Sunnybrook and Women's College Health Sciences Centre.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early External Cephalic Version Group | Experimental | Procedure: Early ECV between 34 0/7 and 35 6/7 weeksEarly external cephalic version (ECV) procedure performed between 34 weeks and 0/7 days and 35 weeks and 6/7 days of gestation |
| Delayed External Cephalic Version Group | Active comparator | Procedure: Delayed ECV at or after 37 0/7 weeksDelayed external cephalic version (ECV) procedure performed at or after 37 weeks and 0/7 days of gestation |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Women with any breech presentation
- A live singleton fetus
- Gestational age of 33 weeks 0 days to 35 weeks 6 days
Key exclusion criteria (7 listed)
- Contraindications to ECV (e.g. fetal heart rate abnormalities, abruptio placenta, major life-threatening fetal anomalies, uterine anomalies, hyper-extended fetal head, rupture of membranes, severe oligohydramnios, severe polyhydramnios)
- Contraindications to early ECV (e.g. increased risk of preterm labour [such as past history of preterm labour in this or previous pregnancies], increased risk of abruptio placenta [such as maternal hypertension])
- Contraindications to labour or vaginal delivery (e.g. placenta previa, previous classical CS)
- Women planning delivery by CS if the fetus turns to cephalic
- Women planning a vaginal delivery if the fetus remains breech
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 |
|---|---|---|
| Early ECV between 34 0/7 and 35 6/7 weeksAlso: Early External Cephalic Version (ECV)Early external cephalic version between 34 0/7 and 35 6/7 weeks of gestation | Procedure or surgery | Early External Cephalic Version Group |
| Delayed ECV at or after 37 0/7 weeksAlso: Delayed External Cephalic Version (ECV)Delayed external cephalic version at or after 37 0/7 weeks of gestation | Procedure or surgery | Delayed External Cephalic Version Group |
Primary outcome
Rate of cesarean section
Time frame: Information not available
1 secondary outcome
Rate of pre-term births. Other outcomes: admission to neonatal intensive care unit ≥ 24 hours, perinatal or neonatal mortality or serious neonatal morbidity, or others.
Time frame: Information not available
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
- Main results: Hutton EK et al. The Early External Cephalic Version (ECV) 2 Trial: an international multicentre randomised controlled trial of timing of ECV for breech pregnancies. BJOG. 2011 Apr;118(5):564-77.Link provided by the sponsor.
- Reitsma A et al. Accounting for center in the Early External Cephalic Version trials: an empirical comparison of statistical methods to adjust for center in a multicenter trial with binary outcomes. Trials. 2014 Sep 26;15:377.Link provided by the sponsor.
- Murray-Davis B. et al. Women's experiences of participating in the early external cephalic version 2 trial. Birth. 2012 Mar;39(1):30-8Link provided by the sponsor.
- Cost analysis: Ahmed RJ, Gafni A, Hutton EK. The Cost Implications in Ontario, Alberta, and British Columbia of Early Versus Delayed External Cephalic Version in the EECV2 Trial. J Obstet Gynaecol Can. 2016 Mar;38(3):235-245.Link provided by the sponsor.
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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.
Dr. Eileen Hutton, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early ECV between 34 0/7 and 35 6/7 weeks and Delayed ECV at or after 37 0/7 weeks in people with Breech Presentation, run by McMaster University at 1 site in Canada.
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 7 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 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of cesarean section (time frame: Information not available). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2016.