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Oxytocin Administration in the Third Stage of Labour - A Study of Appropriate Route and Dose

NCT ID: NCT00200252

Last Updated: 2012-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-07-31

Brief Summary

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Mothers are given the medication oxytocin after birth to help the uterus (womb) contract and therefore reduce blood loss. In Canada, oxytocin is given either into the muscle of the thigh or into a vein. However, it is not known which route is better.This study will test which dose and route of oxytocin is best in reducing blood loss following vaginal delivery.

Detailed Description

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Conditions

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Third Stage of Labour

Keywords

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oxytocin third stage dose route blood loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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group B

women in group B will receive 10 uts oxytocin IM

Group Type ACTIVE_COMPARATOR

oxytocin

Intervention Type DRUG

group C

women in group C will receive oxytocin 5 uts IV

Group Type ACTIVE_COMPARATOR

oxytocin

Intervention Type DRUG

group A

women in group A will receive oxytocin 5 uts IM

Group Type ACTIVE_COMPARATOR

oxytocin

Intervention Type DRUG

Interventions

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oxytocin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* women 19 years and older
* singleton pregnancy
* 32 weeks gestation
* spontaneous vaginal delivery

Exclusion Criteria

* previous postpartum hemorrhage
* placenta previa
* grand multiparity (\>4)
* anticoagulation therapy
* delivery prior to 32 weeks gestation
* operative vaginal delivery
* antepartum hemorrhage \> 20 weeks
* hemoglobin \<10g/dL
* multiple gestation
* intrauterine death
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Memorial University of Newfoundland

OTHER

Sponsor Role lead

Principal Investigators

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Colleen L Cook, MD

Role: PRINCIPAL_INVESTIGATOR

Resident, Discipline Obstetrics and Gynecology, Memorial University of Newfoundland

Joan Crane, MD

Role: STUDY_DIRECTOR

Faculty, Discipline Obstetrics and Gynecolgy, Memorial University of Newfoundland

Locations

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Women's Health Centre, Eastern Health

St. John's, Newfoundland and Labrador, Canada

Site Status

Countries

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Canada

References

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Oladapo OT, Okusanya BO, Abalos E, Gallos ID, Papadopoulou A. Intravenous versus intramuscular prophylactic oxytocin for the third stage of labour. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD009332. doi: 10.1002/14651858.CD009332.pub4.

Reference Type DERIVED
PMID: 33169839 (View on PubMed)

Other Identifiers

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HIC05.79

Identifier Type: -

Identifier Source: org_study_id