A randomised controlled trial of oxytocin 5 IU versus oxytocin 5 IU and 30 IU infusion for the control of blood loss at elective caesarean section: a pilot study
| ISRCTN | ISRCTN40302163 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40302163 |
| Protocol serial number | 2004OB04 |
| Sponsor | NHS Tayside (UK) |
| Funders | Chief Scientist Office (UK) (reference: CGZ/2/185), Obstetric Anaesthetists Association (UK), Tenovus (UK), Anonymous Trust |
- Submission date
- 28/09/2006
- Registration date
- 13/04/2007
- Last edited
- 03/05/2011
- 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 Graeme McLeod
Scientific
Scientific
University Department of Anaesthesia
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double blinded randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | A study to investigate the alternative uses of oxytocin at elective caesarean section and its effect on maternal blood loss. |
| Ethics approval(s) | Medical Research Ethics Committee for Scotland B, Edinburgh in March 2005 (ref: 05/MRE10/20) |
| Health condition(s) or problem(s) studied | Study of blood loss associated with different use of syntocinon |
| Intervention | Women randomly allocated to receive syntocinon 5 IU or syntocinon 5 IU and 30 IU infusion at the time of elective caesarean section using standardised anaesthetic and surgical procedures. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Oxytocin (syntocinon) |
| Primary outcome measure(s) |
The primary outcome measure is estimated blood loss at caesarean section. |
| Key secondary outcome measure(s) |
1. Change in haemoglobin and haematocrit |
| Completion date | 28/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 120 |
| Key inclusion criteria | Pregnant women choosing to have elective caesarean section at term in a healthy low risk pregnancy. |
| Key exclusion criteria | 1. Women who do not understand English 2. Have a pregnancy complicated by thrombocytopenia 3. Coagulopathy or anti-coagulant therapy 4. Are expecting a multiple birth |
| Date of first enrolment | 29/08/2005 |
| Date of final enrolment | 28/09/2006 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
University Department of Anaesthesia
Dundee
DD1 9SY
United Kingdom
DD1 9SY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2009 | Yes | No |
