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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18977579
Publication citations
-
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.