Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0047119214
Study information
Scientific title
Acronym
Study hypothesis
Can we decrease the unwanted effects of syntocinon, namely hypotension and tachycardia, by slowing down the rate of injection?
Ethics approval
Not provided at time of registration
Study design
Prospective randomised controlled single-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Condition
Pregnancy and Childbirth: Anaesthesia
Intervention
Bolus injection (bolus group) vs infusion over 5 min (infusion group)
Intervention type
Drug
Phase
Not Specified
Drug names
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 trial start date
01/11/2002
Overall trial end date
31/01/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
30
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/11/2002
Recruitment end date
31/01/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Anaesthesia
Birmingham
B15 2TG
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Birmingham Women's Healthcare NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17142825
Publication citations
-
Results
Thomas JS, Koh SH, Cooper GM, Haemodynamic effects of oxytocin given as i.v. bolus or infusion on women undergoing Caesarean section., Br J Anaesth, 2007, 98, 1, 116-119, doi: 10.1093/bja/ael302.