IV Versus IM Administration of Oxytocin for Postpartum Bleeding

Postpartum Hemorrhage Clinical Trial

Official title:

Intravenous Versus Intramuscular Administration of Oxytocin and Its Relationship With Postpartum Bleeding and Other Clinical Signs: a Randomized Placebo-controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02954068
• Other study ID #: 3008
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2016
• Est. completion date: October 1, 2017

Study information

• Verified date: April 2018
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This double-blind, randomized controlled trial will evaluate the effect of the route of administration of 10 IU of oxytocin on the average blood loss postpartum. Participants will be randomized to receive 10 IU of oxytocin by IV infusion or 10 IU of oxytocin by injection IM

Recruitment information / eligibility

• Status: Completed
• Enrollment: 543
• Est. completion date: October 1, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• She is present to give birth to a live fetus

• Vaginal delivery

• Willing to participate in the study

• Able to give informed consent

Exclusion Criteria:

• Scheduled for a cesarean

• Reject the placement of an IV during labor (for intravenous infusion)

• Cannot give informed consent for any reason

• Not willing and / or cannot answer questions about background

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• IV Oxytocin + IM placebo

• IM Oxytocin + IV placebo

Locations

Country	Name	City	State
Argentina	Hospital J.R. Vidal	Corrientes

Sponsors (2)

Lead Sponsor	Collaborator
Gynuity Health Projects	Centro Rosarino de Estudios Perinatales (CREP)

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of blood loss (mL)		1 hour postpartum
Primary	Proportion of women who had postpartum blood loss =500 ml		1 hour postpartum
Secondary	Proportion of women who had postpartum blood loss =1000 ml		1 hour postpartum
Secondary	Average change in hemoglobin level		pre-delivery and at least 24 hours postpartum
Secondary	Average time required until expulsion of the placenta		1 hour postpartum
Secondary	Proportion who needed additional Interventions		Through study completion, an average of 24-48 hours postpartum
Secondary	Side effects		1 hour postpartum
Secondary	Blood pressure		15, 30, 45 and 60 minutes postpartum
Secondary	Heart rate		15, 30, 45 and 60 minutes postpartum