A physiological approach to stimulating labour pulse: a randomised controlled trial of pulsatile versus continuous oxytocin administration
| ISRCTN | ISRCTN72773405 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72773405 |
| Protocol serial number | N0453142025 |
| Sponsor | Department of Health |
| Funders | Central Manchester and Manchester Children's University Hospitals NHS Trust, NHS R&D Support Funding + Tommy's Campaign |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 13/10/2014
- 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
Prof Phil Baker
Scientific
Scientific
Central Manchester & Manchester Children's University Hospitals SMH
St Mary's Hospital for Women & Children
Oxford Road
Manchester
M13 0JH
United Kingdom
| Philip.Baker@manchester.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To compare the administration of continuous and pulsatile infusion of oxytoxin for labour induction and augmentation. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pregnancy and Childbirth: Labour |
| Intervention | Randomised controlled trial: pulsatile versus continuous oxytocin administration |
| Intervention type | Other |
| Primary outcome measure(s) |
Increase in normal vaginal delivery rate |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Key inclusion criteria | 407 inductions (pulsatile route) 407 augmentations (pulsatile route) |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 16/02/2004 |
| Date of final enrolment | 30/06/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Central Manchester & Manchester Children's University Hospitals SMH
Manchester
M13 0JH
United Kingdom
M13 0JH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/03/2012 | Yes | No |
