Randomised, double-blinded placebo controlled trial of the use of tocolysis for a repeat external cephalic version after a failed version for breech presentation at term
| ISRCTN | ISRCTN31614268 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31614268 |
| Secondary identifying numbers | SEO093 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 12/01/2010
- 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
Mr Lawrence Impey
Scientific
Scientific
Level 4
The Women's Centre
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
| Phone | +44 (0)1865741166 Ex 21408/21624 |
|---|---|
| LWMI@compuserve.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | To determine the optimum protocol for performing external cephalic version for breech presentation at term. Null hypothesis: that tocolysis for a repeat external cephalic version (ECV) after a failed ECV does not increase the success rates of ECV |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Childbirth |
| Intervention | 1. 50 mg ritodrine hydrochloride infusion 2. 17 ml dextrose saline solution infusion |
| Intervention type | Other |
| Primary outcome measure | 1. Incidence of cephalic presentation at delivery 2. Subjective patient assessment of discomfort 3. Incidence of caesarian section 4. Length of hospital stay 5. Incidence of neonatal Apgar scores <7 at 5 minutes 6. Incidence of neonatal intensive care admission |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 06/04/2000 |
| Completion date | 06/04/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 124 (added 12/01/10, see publication) |
| Key inclusion criteria | 1. Women with suspected or confirmed breech presentation at >36 weeks gestation 2. Have undergone a single (<15 mins) unsuccessful attempt at external cephalic version without tocolysis at 37 or more weeks' gestation |
| Key exclusion criteria | 1. Abnormal cardiotocograph 2. Cardiac disease 3. Pre-existing or gestational diabetes 4. Hypertension; 5. Pre-existing indication for caesarian section 6. Suspected unstable lie 7. Pre-eclampsia 8. recent (<4 weeks) antepartum haemorrhage 9. suspected fetal compromise 10. rhesus immunisation |
| Date of first enrolment | 06/04/2000 |
| Date of final enrolment | 06/04/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Level 4
Oxford
OX3 9DU
United Kingdom
OX3 9DU
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive South East (UK)
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 | 01/05/2005 | Yes | No |
