Oxytocin augmentation vs conservative management for primary dysfunctional labour in nulliparous women: a randomised, controlled trial.
| ISRCTN | ISRCTN78205641 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78205641 |
| Secondary identifying numbers | MCH 02-17 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 03/12/2008
- 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 Kim Hinshaw
Scientific
Scientific
Obstetrics and Gynaecology
City Hospitals Sunderland NHS Trust
Kayll Road
Sunderland
SR4 7TP
United Kingdom
| Phone | +44 (0)191 5656256 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | The aim of the study is to find out whether oxytocin reduces Caesarean Section Rates to assess its effects on other labour and neonatal outcomes and in particular to assess its effects on maternal perception of pain etc and satisfaction with labour. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pregnancy and childbirth: Childbirth |
| Intervention | Not provided at time of registration |
| Intervention type | Other |
| Primary outcome measure | A scientific evaluation of a widely introduced but as yet unproven labour intervention. It will look at the health gain in terms of any subsequent psychological dysfunction. The effects of the different interventions on the Caesarean Section Rates is another primary outcome measure. Any reduction in the Caesarean Section Rate is likely to have economic benefit to the NHS in terms of cost reduction. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/08/1998 |
| Completion date | 01/02/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Added December 2008: 412 |
| Key inclusion criteria | Women in spontaneous labour in their first pregnancy at term (37-42 weeks). There must be a singleton vertex presentation with no significant antenatal or intrapartum problems. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/08/1998 |
| Date of final enrolment | 01/02/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Obstetrics and Gynaecology
Sunderland
SR4 7TP
United Kingdom
SR4 7TP
United Kingdom
Sponsor information
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
NHS Mother and Child Health National Research and Development Programme (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 | 01/09/2008 | Yes | No |
