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
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

Department of Anaesthesia
Birmingham Women's Hospital
Edgbaston
Birmingham
B15 2TG
United Kingdom

Phone +44 (0)121 472 1377 ext 4088

Study information

Study designProspective randomised controlled single-centre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Scientific title
Study objectivesCan 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) studiedPregnancy and Childbirth: Anaesthesia
InterventionBolus injection (bolus group) vs infusion over 5 min (infusion group)
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)syntocinon
Primary outcome measureReason for study ie to determine a method that can be used to routinely limit the decrease in blood pressure.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/11/2002
Completion date31/01/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants30
Key inclusion criteriaWomen 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 criteriaNot provided at time of registration
Date of first enrolment01/11/2002
Date of final enrolment31/01/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Anaesthesia
Birmingham
B15 2TG
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Birmingham Women's Healthcare NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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