Condition category
Pregnancy and Childbirth
Date applied
28/09/2006
Date assigned
13/04/2007
Last edited
03/05/2011
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 Graeme McLeod

ORCID ID

Contact details

University Department of Anaesthesia
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2004OB04

Study information

Scientific title

Acronym

Study hypothesis

A study to investigate the alternative uses of oxytocin at elective caesarean section and its effect on maternal blood loss.

Ethics approval

Medical Research Ethics Committee for Scotland B, Edinburgh in March 2005 (ref: 05/MRE10/20)

Study design

Double blinded randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Study of blood loss associated with different use of syntocinon

Intervention

Women randomly allocated to receive syntocinon 5 IU or syntocinon 5 IU and 30 IU infusion at the time of elective caesarean section using standardised anaesthetic and surgical procedures.

Intervention type

Drug

Phase

Not Specified

Drug names

Oxytocin (syntocinon)

Primary outcome measures

The primary outcome measure is estimated blood loss at caesarean section.

Secondary outcome measures

1. Change in haemoglobin and haematocrit
2. Need for additional uterotonic agents
3. Incidence of major obstetric haemorrhage
4. Need for blood transfusion, side effects and length of sat in the labour ward

Overall trial start date

29/08/2005

Overall trial end date

28/09/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Pregnant women choosing to have elective caesarean section at term in a healthy low risk pregnancy.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

120

Participant exclusion criteria

1. Women who do not understand English
2. Have a pregnancy complicated by thrombocytopenia
3. Coagulopathy or anti-coagulant therapy
4. Are expecting a multiple birth

Recruitment start date

29/08/2005

Recruitment end date

28/09/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Department of Anaesthesia
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

NHS Tayside (UK)

Sponsor details

c/o Professor J Stewart Forsyth
Ninewells Hospital and Medical School
Medical Director's Office
Single Divisional Unit
Level 10
Dundee
DD1 9SY
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.nhstayside.scot.nhs.uk/

Funders

Funder type

Government

Funder name

Chief Scientist Office (UK) (reference: CGZ/2/185)

Alternative name(s)

CSO

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

United Kingdom

Funder name

Obstetric Anaesthetists Association (UK)

Alternative name(s)

OAA

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

Funder name

Tenovus (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Anonymous Trust

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18977579

Publication citations

  1. Results

    Murphy DJ, MacGregor H, Munishankar B, McLeod G, A randomised controlled trial of oxytocin 5IU and placebo infusion versus oxytocin 5IU and 30IU infusion for the control of blood loss at elective caesarean section--pilot study. ISRCTN 40302163., Eur. J. Obstet. Gynecol. Reprod. Biol., 2009, 142, 1, 30-33, doi: 10.1016/j.ejogrb.2008.09.004.

Additional files

Editorial Notes