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

Not Applicable

Completed

• Conditions: Study of blood loss at caesarean section associated with different use of oxytocin; Signs and Symptoms; Control of blood loss

• Registration Number: ISRCTN17813715
• Lead Sponsor: Health Research Board of Ireland (Ireland)

Brief Summary

1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19703279 2. 2011 results in: https://www.ncbi.nlm.nih.gov/pubmed/21807773 (added 21/08/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-25
• Study Completion: 2009-12-31
• Last Update Posted: 9 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 2069

Inclusion Criteria

1. Healthy women
2. Greater than 36 weeks gestation
3. Singleton pregnancies
4. Booked for elective caesarean section

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> To compare:<br> 1. The incidence of major obstetric haemorrhage (greater than or equal to 1000 ml)<br> 2. The need for an additional uterotonic agent<br><br> We will define major obstetric haemorrhage in two ways:<br> 1. Estimated blood loss as described by theatre staff<br> 2. Estimated blood loss as calculated from pre- and post-operative haematocrit. The post-operative haematocrit will be measured at 48 hours.<br>

Secondary Outcome Measures

Name	Time	Method
<br> To compare:<br> 1. The estimated mean operative blood loss and early lochial loss<br> 2. The objective change in haemoglobin (Hb) and haematocrit before and 48 hours after delivery<br> 3. The incidence of severe anaemia (Hb fall greater than or equal to 20%) 48 hours after delivery<br> 4. The need for blood transfusion and/or blood products<br> 5. The incidence of side effects<br> 6. The post-natal length of stay on the labour ward and in the hospital<br><br> 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.<br>