A Randomized Trial Comparing Oxytocin and Oxytocin + Ergo... | NCT02046499

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

NCT02046499

Sponsor

University of Pretoria

Status

Completed

Last Update Posted

Mar 9, 2021Actual

Enrollment

540Actual

Phase

Not Applicable

Conditions

Prevention of Post Partum Haemorrhage

Interventions

Oxytocin
Oxytocin ergometrine

Countries

South Africa

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2014Actual

Primary Completion Date

Jun 30, 2014Actual

Completion Date

Sep 30, 2014Actual

First Submitted Date

Jan 23, 2014

First Submission Date that Met QC Criteria

Jan 23, 2014

First Posted Date

Jan 27, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2021

Last Update Posted Date

Mar 9, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

540Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Oxytocin	Drug	Oxytocin will be administered intravenously as per standard protocol	Oxytocin arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leon C Snyman, MbChB MMed	Department Obstetrics & Gynaecology, University of Pretoria, South Africa	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kalafong Academic Hospital		Pretoria	Gauteng	0001	South Africa

Condition Browse Module

MeSH Terms

ID	Term
D006473	Postpartum Hemorrhage

Ancestor Terms

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010121	Oxytocin
C038346	syntometrine

Ancestor Terms

ID	Term
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones

Browse Leaves

Not provided

Browse Branches

Not provided