A study to determine the cardiovascular effects of different methods of administering the oxytocic drug Syntocinon
ISRCTN | ISRCTN07452238 |
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DOI | https://doi.org/10.1186/ISRCTN07452238 |
Secondary identifying numbers | N0047119214 |
- 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 |
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Study information
Study design | Prospective randomised controlled single-centre trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Quality of life |
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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | syntocinon |
Primary outcome measure | Reason for study ie to determine a method that can be used to routinely limit the decrease in blood pressure. |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/11/2002 |
Completion date | 31/01/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 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
- England
- United Kingdom
Study participating centre
Department of Anaesthesia
Birmingham
B15 2TG
United Kingdom
B15 2TG
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 |
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Funders
Funder type
Government
Birmingham Women's Healthcare NHS Trust (UK)
No information available
Results and Publications
Intention to publish date | |
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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? |
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Results article | results | 01/01/2007 | Yes | No |