A randomised controlled trial of oxytocin bolus versus oxytocin bolus and infusion for the control of blood loss at elective caesarean section

ISRCTN	ISRCTN17813715
DOI	https://doi.org/10.1186/ISRCTN17813715
Clinical Trials Information System (CTIS)	2006-004799-11
Protocol serial number	EudraCT number 2006-004799-11
Sponsor	Health Research Board of Ireland (Ireland)
Funder	Health Research Board of Ireland (Ireland) (ref: RP/2007/171)

Submission date: 10/12/2007
Registration date: 25/03/2008
Last edited: 21/08/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Deirdre J. Murphy
Scientific

Department of Obstetrics & Gynaecology
Trinity College Dublin
Coombe Women's Hospital
Dublin
8
Ireland

Study information

Primary study design	Interventional
Study design	Multi-centre double blinded randomised controlled trial.
Secondary study design	Randomised controlled trial
Scientific title	A multi-centre randomised controlled trial of oxytocin 5 IU bolus and placebo infusion versus oxytocin 5 IU bolus and 40 IU infusion for the control of blood loss at elective caesarean section
Study acronym	ECSSIT - Elective Caesarean Section Syntocinon Infusion Trial
Study objectives	The hypothesis is that an oxytocin infusion used in addition to an oxytocin bolus at elective caesarean section will reduce the risk of major haemorrhage and anaemia. Please note that the pilot study to this trial is assigned to ISRCTN40302163: 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 (see http://www.controlled-trials.com/ISRCTN40302163).
Ethics approval(s)	Ethics approval received from the Central Trials Ethics Committee (National Maternity Hospital, Holles Street, Dublin, Ireland) on the 29th November 2007.
Health condition(s) or problem(s) studied	Study of blood loss at caesarean section associated with different use of oxytocin
Intervention	Patients will be randomised in a double-blind trial to receive either: 1. An intravenous slow bolus of oxytocin (5 IU) and placebo infusion (500 ml 0.9% saline), or 2. An intravenous slow bolus of oxytocin (5 IU) and oxytocin infusion (40 IU in 500 ml 0.9% saline over four hours) At elective caesarean section. The patients will be followed-up until discharge from the hospital post-natally.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Oxytocin
Primary outcome measure(s)	To compare: 1. The incidence of major obstetric haemorrhage (greater than or equal to 1000 ml) 2. The need for an additional uterotonic agent We will define major obstetric haemorrhage in two ways: 1. Estimated blood loss as described by theatre staff 2. Estimated blood loss as calculated from pre- and post-operative haematocrit. The post-operative haematocrit will be measured at 48 hours.
Key secondary outcome measure(s)	To compare: 1. The estimated mean operative blood loss and early lochial loss 2. The objective change in haemoglobin (Hb) and haematocrit before and 48 hours after delivery 3. The incidence of severe anaemia (Hb fall greater than or equal to 20%) 48 hours after delivery 4. The need for blood transfusion and/or blood products 5. The incidence of side effects 6. The post-natal length of stay on the labour ward and in the hospital The outcomes will be measured at various timepoints - from the time of the operation to discharge from the hospital. Clinical follow-up of the mother will be completed prior to hospital discharge.
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	1500
Total final enrolment	2069
Key inclusion criteria	1. Healthy women 2. Greater than 36 weeks gestation 3. Singleton pregnancies 4. Booked for elective caesarean section
Key exclusion criteria	1. Placenta praevia 2. Thrombocytopaenia 3. Coagulopathies 4. Previous major obstetric haemorrhage (greater than 1000 ml) 5. Patients receiving anti-coagulant therapy 6. Non-English speakers 7. Under 18 years of age
Date of first enrolment	01/01/2008
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

Ireland

Study participating centre

Department of Obstetrics & Gynaecology

Dublin
8
Ireland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/08/2011	21/08/2019	Yes	No
Protocol article	protocol	24/08/2009		Yes	No

Editorial Notes

21/08/2019: Publication reference and total final enrolment added.