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12 May 2008
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| [ Print-friendly version ] |
| A randomised controlled trial of oxytocin bolus versus oxytocin bolus and infusion for the control of blood loss at elective caesarean section |
| ISRCTN | ISRCTN17813715 |
| ClinicalTrials.gov identifier | |
| Public title | A randomised controlled trial of oxytocin bolus versus oxytocin bolus and infusion for the control of blood loss at elective caesarean section |
| 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 |
| Serial number at source | EudraCT number 2006-004799-11 |
| 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. |
| Countries of recruitment | Ireland |
| Disease/condition/study domain | Study of blood loss at caesarean section associated with different use of oxytocin |
| Participants - inclusion criteria |
1. Healthy women
2. Greater than 36 weeks gestation 3. Singleton pregnancies 4. Booked for elective caesarean section |
| Participants - 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 |
| Anticipated start date | 01/01/2008 |
| Anticipated end date | 31/12/2009 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | 1500 |
| Interventions |
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. |
| 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. |
| 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. |
| Sources of funding | Health Research Board of Ireland (Ireland) (ref: RP/2007/171) |
| Trial website | |
| Publications | |
| Contact name | Prof Deirdre J. Murphy |
| Address |
Department of Obstetrics & Gynaecology
Trinity College Dublin Coombe Women's Hospital |
| City/town | Dublin |
| Zip/Postcode | 8 |
| Country | Ireland |
| Sponsor | Health Research Board of Ireland (Ireland) |
| Address | 73 Lower Baggot Street |
| City/town | Dublin |
| Zip/Postcode | 2 |
| Country | Ireland |
| info@hrb.ie | |
| Sponsor website: | http://www.hrb.ie |
| Date applied | 10/12/2007 |
| Last edited | 25/03/2008 |
| Date ISRCTN assigned | 25/03/2008 |
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