Back to resultsIV Versus IM Administration of Oxytocin for Postpartum Bleeding
Primary Purpose
Postpartum Hemorrhage
Status
Completed
Phase
Phase 4
Locations
Argentina
Study Type
Interventional
Intervention
IV Oxytocin + IM placebo
IM Oxytocin + IV placebo
Sponsored by
About this trial
This is an interventional prevention trial for Postpartum Hemorrhage focused on measuring Oxytocin
Eligibility Criteria
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
Sites / Locations
- Hospital J.R. Vidal
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
IV Infusion
IM administration
Arm Description
Oxytocin 10 IU, 500 ml IV infusion within 40 minutes + intra muscular injection of placebo, 10 IU
Oxytocin 10 IU via intra muscular injection + Intravenously administered placebo, 10 IU, 500ml
Outcomes
Primary Outcome Measures
Amount of blood loss (mL)
Proportion of women who had postpartum blood loss ≥500 ml
Secondary Outcome Measures
Proportion of women who had postpartum blood loss ≥1000 ml
Average change in hemoglobin level
Average time required until expulsion of the placenta
Proportion who needed additional Interventions
Side effects
Blood pressure
Heart rate
Full Information
NCT ID
NCT02954068
First Posted
October 28, 2016
Last Updated
April 27, 2018
Sponsor
Gynuity Health Projects
Collaborators
Centro Rosarino de Estudios Perinatales (CREP)
1. Study Identification
Unique Protocol Identification Number
NCT02954068
Brief Title
IV Versus IM Administration of Oxytocin for Postpartum Bleeding
Official Title
Intravenous Versus Intramuscular Administration of Oxytocin and Its Relationship With Postpartum Bleeding and Other Clinical Signs: a Randomized Placebo-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
October 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynuity Health Projects
Collaborators
Centro Rosarino de Estudios Perinatales (CREP)
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
Oxytocin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
543 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IV Infusion
Arm Type
Active Comparator
Arm Description
Oxytocin 10 IU, 500 ml IV infusion within 40 minutes + intra muscular injection of placebo, 10 IU
Arm Title
IM administration
Arm Type
Active Comparator
Arm Description
Oxytocin 10 IU via intra muscular injection + Intravenously administered placebo, 10 IU, 500ml
Intervention Type
Drug
Intervention Name(s)
IV Oxytocin + IM placebo
Intervention Type
Drug
Intervention Name(s)
IM Oxytocin + IV placebo
Primary Outcome Measure Information:
Title
Amount of blood loss (mL)
Time Frame
1 hour postpartum
Title
Proportion of women who had postpartum blood loss ≥500 ml
Time Frame
1 hour postpartum
Secondary Outcome Measure Information:
Title
Proportion of women who had postpartum blood loss ≥1000 ml
Time Frame
1 hour postpartum
Title
Average change in hemoglobin level
Time Frame
pre-delivery and at least 24 hours postpartum
Title
Average time required until expulsion of the placenta
Time Frame
1 hour postpartum
Title
Proportion who needed additional Interventions
Time Frame
Through study completion, an average of 24-48 hours postpartum
Title
Side effects
Time Frame
1 hour postpartum
Title
Blood pressure
Time Frame
15, 30, 45 and 60 minutes postpartum
Title
Heart rate
Time Frame
15, 30, 45 and 60 minutes postpartum
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beverly Winikoff, MD, MPH
Organizational Affiliation
Gynuity Health Projects
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ilana Dzuba, MPH
Organizational Affiliation
Gynuity Health Projects
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guillermo Carroli, MD
Organizational Affiliation
Centro Rosarino de Estudios Perinatales (CREP)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital J.R. Vidal
City
Corrientes
Country
Argentina
12. IPD Sharing Statement
Citations:
PubMed Identifier
33169839
Citation
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.
Results Reference
derived
Learn more about this trial
IV Versus IM Administration of Oxytocin for Postpartum Bleeding
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