Additional identifiers
EudraCT number
2006-004799-11
ClinicalTrials.gov number
Protocol/serial number
EudraCT number 2006-004799-11
Study information
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
Acronym
ECSSIT - Elective Caesarean Section Syntocinon Infusion Trial
Study hypothesis
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
Ethics approval received from the Central Trials Ethics Committee (National Maternity Hospital, Holles Street, Dublin, Ireland) on the 29th November 2007.
Study design
Multi-centre 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 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 names
Oxytocin
Primary outcome measure
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.
Secondary outcome measures
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.
Overall trial start date
01/01/2008
Overall trial end date
31/12/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Healthy women
2. Greater than 36 weeks gestation
3. Singleton pregnancies
4. Booked for elective caesarean section
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1500 (2000 as of 15/08/2008)
Participant 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
Recruitment start date
01/01/2008
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Ireland
Trial participating centre
Department of Obstetrics & Gynaecology
Dublin
8
Ireland
Sponsor information
Organisation
Health Research Board of Ireland (Ireland)
Sponsor details
73 Lower Baggot Street
Dublin
2
Ireland
info@hrb.ie
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Health Research Board of Ireland (Ireland) (ref: RP/2007/171)
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 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19703279
Publication citations
-
Protocol
Murphy DJ, Carey M, Montgomery AA, Sheehan SR, , Study protocol. ECSSIT - Elective Caesarean Section Syntocinon Infusion Trial. A multi-centre randomised controlled trial of oxytocin (Syntocinon) 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., BMC Pregnancy Childbirth, 2009, 9, 36, doi: 10.1186/1471-2393-9-36.