A randomised controlled trial of oxytocin 5 IU versus oxytocin 5 IU and 30 IU infusion for the control of blood loss at elective caesarean section: a pilot study

ISRCTN	ISRCTN40302163
DOI	https://doi.org/10.1186/ISRCTN40302163
Secondary identifying numbers	2004OB04

Submission date: 28/09/2006
Registration date: 13/04/2007
Last edited: 03/05/2011

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 Graeme McLeod
Scientific

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

Study information

Study design	Double blinded randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	A study to investigate the alternative uses of oxytocin at elective caesarean section and its effect on maternal blood loss.
Ethics approval(s)	Medical Research Ethics Committee for Scotland B, Edinburgh in March 2005 (ref: 05/MRE10/20)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	29/08/2005
Completion date	28/09/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	120
Key inclusion criteria	Pregnant women choosing to have elective caesarean section at term in a healthy low risk pregnancy.
Key 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
Date of first enrolment	29/08/2005
Date of final enrolment	28/09/2006

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

University Department of Anaesthesia

Dundee
DD1 9SY
United Kingdom

Sponsor information

NHS Tayside (UK)
Hospital/treatment centre

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

Website	http://www.nhstayside.scot.nhs.uk/
"ROR"	https://ror.org/000ywep40

Funders

Funder type

Government

Chief Scientist Office (UK) (reference: CGZ/2/185)
Government organisation / Local government

Alternative name(s): CSO
Location: United Kingdom

Obstetric Anaesthetists Association (UK)
Private sector organisation / Associations and societies (private and public)

Alternative name(s): OAA
Location: United Kingdom

Tenovus (UK)
Private sector organisation / Other non-profit organizations

Alternative name(s): Tenovus Cancer Care
Location: United Kingdom

Anonymous Trust

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2009		Yes	No