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

NCT02046499 | Completed DMC

• 1 other identifier: PPH Prevention Trial
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prevention of Post Partum Haemorrhage

Keywords

Prevention, post partum haemorrhage

Outcome Measures

Primary Outcomes (1)

• Blood loss

  Estimated blood loss at caesarean section

  60 minutes

Secondary Outcomes (3)

• Side effects of oxytocin compared to oxytocin + ergometrine

  24 hours

• Need for additional uterotonics

  60 minutes

• Number of units blood transfused

  24 hours

Study Arms (2)

Oxytocin arm

ACTIVE COMPARATOR

Oxytocin alone administered which is current standard of care

Drug: Oxytocin

Oxytocin + syntometrine

EXPERIMENTAL

Oxytocin plus syntometrine administered

Drug: Oxytocin ergometrine

Interventions

Oxytocin DRUG

Oxytocin will be administered intravenously as per standard protocol

Oxytocin arm

Oxytocin ergometrine DRUG

Oxytocin ergometrine will be administered intra-musculalry

Also known as: Syntometrine

Oxytocin + syntometrine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women delivering by caesarean section older than 18 years willing and able to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pretoria: lead

Study Sites (1)

Kalafong Academic Hospital

Pretoria, Gauteng, 0001, South Africa

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Oxytocin; syntometrine

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Leon C Snyman, MbChB MMed

  Department Obstetrics & Gynaecology, University of Pretoria, South Africa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Specialist

Study Record Dates

• First Submitted: January 23, 2014
• First Posted: January 27, 2014
• Study Start: January 1, 2014
• Primary Completion: June 30, 2014
• Study Completion: September 30, 2014
• Last Updated: March 9, 2021

Record last verified: 2021-03

Locations

ZA (1)