A study to determine the cardiovascular effects of different methods of administering the oxytocic drug Syntocinon
| ISRCTN | ISRCTN07452238 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07452238 |
| Protocol serial number | N0047119214 |
| Sponsor | Department of Health (UK) |
| Funder | Birmingham Women's Healthcare NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 12/05/2009
- 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 GM Cooper
Scientific
Scientific
Department of Anaesthesia
Birmingham Women's Hospital
Edgbaston
Birmingham
B15 2TG
United Kingdom
| Phone | +44 (0)121 472 1377 ext 4088 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised controlled single-centre trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Can we decrease the unwanted effects of syntocinon, namely hypotension and tachycardia, by slowing down the rate of injection? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pregnancy and Childbirth: Anaesthesia |
| Intervention | Bolus injection (bolus group) vs infusion over 5 min (infusion group) |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | syntocinon |
| Primary outcome measure(s) |
Reason for study ie to determine a method that can be used to routinely limit the decrease in blood pressure. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 30 |
| Key inclusion criteria | Women choosing spinal anaesthesia for elective Caesarean: 15 in control group receiving syntocinon 5 units intravenously (IV) as a bolus after delivery 15 in study group receiving syntocinon 5 units IV continuously over 5 min after delivery |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/11/2002 |
| Date of final enrolment | 31/01/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Anaesthesia
Birmingham
B15 2TG
United Kingdom
B15 2TG
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 | 01/01/2007 | Yes | No |
