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 |
| EudraCT/CTIS number | 2006-004799-11 |
| Secondary identifying numbers | EudraCT number 2006-004799-11 |
- 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
Scientific
Department of Obstetrics & Gynaecology
Trinity College Dublin
Coombe Women's Hospital
Dublin
8
Ireland
Study information
| Study design | Multi-centre double blinded randomised controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/01/2008 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 1500 (2000 as of 15/08/2008) |
| 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
8
Ireland
Sponsor information
Health Research Board of Ireland (Ireland)
Government
Government
73 Lower Baggot Street
Dublin
2
Ireland
| info@hrb.ie | |
| Website | http://www.hrb.ie |
"ROR" |
https://ror.org/003hb2249 |
Funders
Funder type
Government
Health Research Board of Ireland (Ireland) (ref: RP/2007/171)
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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 24/08/2009 | Yes | No | |
| Results article | results | 01/08/2011 | 21/08/2019 | Yes | No |
Editorial Notes
21/08/2019: Publication reference and total final enrolment added.
