Condition category
Signs and Symptoms
Date applied
10/12/2007
Date assigned
25/03/2008
Last edited
21/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Deirdre J. Murphy

ORCID ID

Contact details

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

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 measures

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

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

http://www.hrb.ie

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

Results - basic reporting

Publication summary

2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19703279

Publication citations

  1. 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.

Additional files

Editorial Notes