Condition category
Pregnancy and Childbirth
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
12/05/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr GM Cooper

ORCID ID

Contact details

Department of Anaesthesia
Birmingham Women's Hospital
Edgbaston
Birmingham
B15 2TG
United Kingdom
+44 (0)121 472 1377 ext 4088

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17142825

Publication citations

  1. 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.

Additional files

Editorial Notes