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

Prevention of Post Partum Haemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02046499
• Other study ID #: PPH Prevention Trial
• Status: Completed
• Phase: N/A
• Start date: January 1, 2014
• Est. completion date: September 30, 2014

Study information

• Verified date: March 2021
• Source: University of Pretoria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized trial comparing oxytocin versus oxytocin + syntometrine in the prevention of post partum haemorrhage in patients undergoing caesarean section

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: September 30, 2014
• Est. primary completion date: June 30, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage
• Prevention of Post Partum Haemorrhage

Intervention

Drug:
• Oxytocin
Oxytocin will be administered intravenously as per standard protocol
• Oxytocin ergometrine
Oxytocin ergometrine will be administered intra-musculalry

Locations

Country	Name	City	State
South Africa	Kalafong Academic Hospital	Pretoria	Gauteng

Sponsors (1)

Lead Sponsor	Collaborator
University of Pretoria

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss	Estimated blood loss at caesarean section	60 minutes
Secondary	Side effects of oxytocin compared to oxytocin + ergometrine	Compare side effects experienced by women administered oxytocin compared to oxytocin plus ergometrine	24 hours
Secondary	Need for additional uterotonics	To determine the need for additional uterotonics to treat post partum haemorrhage	60 minutes
Secondary	Number of units blood transfused	Compare the number of units blood required for transfusion between the two arms	24 hours