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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02046499

Enrollment

540

Registered

2014-01-27

Start date

2014-01-01

Completion date

2014-09-30

Last updated

2021-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of Post Partum Haemorrhage

Keywords

Prevention, post partum haemorrhage

Brief summary

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

Interventions

DRUGOxytocin

Oxytocin will be administered intravenously as per standard protocol

DRUGOxytocin ergometrine

Oxytocin ergometrine will be administered intra-musculalry

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Blood loss	60 minutes	Estimated blood loss at caesarean section

Secondary

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

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026