Randomised trial of intrapartum tractocile versus placebo in the management of fetal distress in women undergoing emergency Caesarean section
| ISRCTN | ISRCTN59759835 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59759835 |
| Secondary identifying numbers | N0059103677 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 05/10/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Tom Farrell
Scientific
Scientific
STH NHS Trust
OGN & Midwifery
Jessop Wing
Sheffield
S10 2SF
United Kingdom
| Phone | +44 (0)114 226 8163 |
|---|---|
| tom.farrell@sth.nhs.uk |
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 | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pregnancy and Childbirth: Fetal distress |
| Intervention | Intrapartum tractocile versus placebo. Added June 2008: trial abandoned and never recruited patients. |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/03/2004 |
| Completion date | 28/02/2006 |
| Reason abandoned (if study stopped) | Lack of resources |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Recruitment target: 240 |
| Key inclusion criteria | Women undergoing emergency Caesarean section. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/03/2004 |
| Date of final enrolment | 28/02/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
STH NHS Trust
Sheffield
S10 2SF
United Kingdom
S10 2SF
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Sheffield Teaching Hospitals (Central Campus) - 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 |
