Breech Presentation at Term Clinical Trial
Official title:
Clinical Hypnosis Versus Neuro-linguistic Programming Before External Cephalic Version (ECV) - a Prospective Off-centre Randomised Controlled Trial
| Verified date | March 2012 |
| Source | Johann Wolfgang Goethe University Hospitals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics Commission |
| Study type | Interventional |
Does clinical hypnosis or neuro-linguistic programming improve the success rate of external cephalic version?
| Status | Recruiting |
| Enrollment | 716 |
| Est. completion date | September 2014 |
| Est. primary completion date | February 2014 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - singleton - breech presentation - gestation age above 36 weeks + 6 days Exclusion Criteria: - multiples - cannot understand German language |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Department of obstetrics and gynaecology, Johann Wolfgang Goethe University | Frankfurt | Hessen |
| Lead Sponsor | Collaborator |
|---|---|
| Johann Wolfgang Goethe University Hospitals |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Successful ECV | Rate of cephalic presentation three hours after external cephalic version. | 3 hours after ECV treatment | No |
| Secondary | Questionnaire | before and 30 minutes after ECV | No |