IV Versus IM Administration of Oxytocin for Postpartum Bleeding
Intravenous Versus Intramuscular Administration of Oxytocin and Its Relationship With Postpartum Bleeding and Other Clinical Signs: a Randomized Placebo-controlled Study
1 other identifier
interventional
543
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2016
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2016
CompletedFirst Posted
Study publicly available on registry
November 3, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedApril 30, 2018
April 1, 2018
10 months
October 28, 2016
April 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Amount of blood loss (mL)
1 hour postpartum
Proportion of women who had postpartum blood loss ≥500 ml
1 hour postpartum
Secondary Outcomes (7)
Proportion of women who had postpartum blood loss ≥1000 ml
1 hour postpartum
Average change in hemoglobin level
pre-delivery and at least 24 hours postpartum
Average time required until expulsion of the placenta
1 hour postpartum
Proportion who needed additional Interventions
Through study completion, an average of 24-48 hours postpartum
Side effects
1 hour postpartum
- +2 more secondary outcomes
Study Arms (2)
IV Infusion
ACTIVE COMPARATOROxytocin 10 IU, 500 ml IV infusion within 40 minutes + intra muscular injection of placebo, 10 IU
IM administration
ACTIVE COMPARATOROxytocin 10 IU via intra muscular injection + Intravenously administered placebo, 10 IU, 500ml
Interventions
Eligibility Criteria
You may qualify if:
- She is present to give birth to a live fetus
- Vaginal delivery
- Willing to participate in the study
- Able to give informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital J.R. Vidal
Corrientes, Argentina
Related Publications (1)
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.
PMID: 33169839DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beverly Winikoff, MD, MPH
Gynuity Health Projects
- PRINCIPAL INVESTIGATOR
Ilana Dzuba, MPH
Gynuity Health Projects
- PRINCIPAL INVESTIGATOR
Guillermo Carroli, MD
Centro Rosarino de Estudios Perinatales (CREP)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2016
First Posted
November 3, 2016
Study Start
December 1, 2016
Primary Completion
September 30, 2017
Study Completion
October 1, 2017
Last Updated
April 30, 2018
Record last verified: 2018-04