External cephalic version trial
| ISRCTN | ISRCTN28715121 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28715121 |
| Secondary identifying numbers | NTR140 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 04/08/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M. Kok
Scientific
Scientific
Academic Medical Centre
Department of Obstetrics and Gynaecology
H4-205, Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 5664167 |
|---|---|
| mkok@amc.uva.nl |
Study information
| Study design | Multicentre, randomised, double blind, placebo controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Management of breech presentation - external cephalic version with tocolysis: a multicentre randomised controlled trial |
| Study objectives | For women with a singleton at term foetus in breech presentation, what is the success rate of external cephalic version (ECV) with a calcium antagonist nifedipine compared to version without medication? |
| Ethics approval(s) | Ethics approval received from local ethics committee |
| Health condition(s) or problem(s) studied | Breech presentation |
| Intervention | Group 1: external cephalic version with tocolysis (adalat 10 mg orally 30 and 15 minutes before procedure) Group 2: external cephalic version without tocolysis. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Tocolysis |
| Primary outcome measure | Successful version. |
| Secondary outcome measures | 1. Cephalic presentation at birth 2. Caesarean section rate 3. Foetal complications 4. Maternal complications |
| Overall study start date | 01/08/2004 |
| Completion date | 01/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 300 |
| Key inclusion criteria | Pregnant women (from 18 years of age) with a live singleton at term foetus in breech presentation. |
| Key exclusion criteria | 1. Contraindications to labour or vaginal birth 2. Any contraindication to ECV 3. Contraindications for nifedipine |
| Date of first enrolment | 01/08/2004 |
| Date of final enrolment | 01/05/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Sponsor information
Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Website | http://www.amc.uva.nl/ |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Hospital/treatment centre
Academic Medical Centre (AMC) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/08/2008 | Yes | No |
