IV Versus IM Administration of Oxytocin for Postpartum Bleeding

Gynuity Health Projects

Status and phase: Completed; Phase 4

Conditions: Postpartum Hemorrhage

Treatments: Drug: IV Oxytocin + IM placebo; Drug: IM Oxytocin + IV placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02954068

3008

Details and patient eligibility

About

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

Enrollment: 543 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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543 participants in 2 patient groups

IV Infusion

Active Comparator group

Description:

Oxytocin 10 IU, 500 ml IV infusion within 40 minutes + intra muscular injection of placebo, 10 IU

Treatment:

Drug: IV Oxytocin + IM placebo

IM administration

Active Comparator group

Description:

Oxytocin 10 IU via intra muscular injection + Intravenously administered placebo, 10 IU, 500ml

Treatment:

Drug: IM Oxytocin + IV placebo