A Randomized Trial Comparing Oxytocin and Oxytocin + Ergometrine for Prevention of Postpartum Haemorrhage at Caesarean Section

Study Overview
=================
Brief Summary
-----------------
This is a randomized trial comparing oxytocin versus oxytocin + syntometrine in the prevention of post partum haemorrhage in patients undergoing caesarean section

Official Title
-----------------
A Randomized Trial Comparing Oxytocin and Oxytocin + Ergometrine for Prevention of Postpartum Haemorrhage at Caesarean Section

Conditions
-----------------
Prevention of Post Partum Haemorrhage

Intervention / Treatment
-----------------
* Drug: Oxytocin
* Drug: Oxytocin ergometrine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women delivering by caesarean section older than 18 years willing and able to give informed consent Exclusion Criteria: • Women not willing or women not able to provide consent Women who have a classical caesarean section Women younger than 18 years of age Women with any of the following conditions will be excluded (ergometrine contra-indicated in patients with these conditions). Pre- eclampsia Eclampsia, Uncontrolled hypertension (hypertension defined as systolic blood pressure more than 140 mm Hg and diastolic blood pressure more than 90 mm Hg) Any cardiac lesion Impaired liver function Impaired kidney function Hypersensitivity to any of the active ingredients of the preparations that will be used (Syntometrine® or Syntocinon®) Occlusive vascular disease Autoimmune vasculitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxytocin arm<br>Oxytocin alone administered which is current standard of care | Drug: Oxytocin<br>* Oxytocin will be administered intravenously as per standard protocol<br>|
| Experimental: Oxytocin + syntometrine<br>Oxytocin plus syntometrine administered | Drug: Oxytocin ergometrine<br>* Oxytocin ergometrine will be administered intra-musculalry<br>* Other names: Syntometrine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss | Estimated blood loss at caesarean section | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects of oxytocin compared to oxytocin + ergometrine | Compare side effects experienced by women administered oxytocin compared to oxytocin plus ergometrine | 24 hours | 
| Need for additional uterotonics | To determine the need for additional uterotonics to treat post partum haemorrhage | 60 minutes | 
| Number of units blood transfused | Compare the number of units blood required for transfusion between the two arms | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prevention, post partum haemorrhage