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Oxytocin Via Intramuscular Injection and Intravenous Bolus or Infusion for Prevention of Postpartum Hemorrhage

Primary Purpose

Postpartum Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Oxytocin
Sponsored by
Gynuity Health Projects
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage focused on measuring Postpartum hemorrhage, Oxytocin, Prevention, Third stage of labor, Hemoglobin, Intravenous, Intramuscular, Bolus

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • All women who present in active labor for a live birth at the study hospital will be considered for participation in the study

Exclusion Criteria:

  • Planned or transferred for delivery via Cesarean section
  • Administration of a pre-delivery uterotonic to induce or augment labor
  • Unable to provide informed consent due to mental impairment, distress during labor or other reason

Sites / Locations

  • Shatby Maternity Hospital, Alexandria University
  • El Galaa Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

IV infusion

IV bolus

IM injection

Arm Description

Oxytocin 10 IU will be administered by IV infusion according to randomization assignment as soon as possible after delivery of the baby.

Oxytocin 10 IU will be administered by IV bolus according to randomization assignment as soon as possible after delivery of the baby.

Oxytocin 10 IU will be administered by IM injection according to randomization assignment as soon as possible after delivery of the baby.

Outcomes

Primary Outcome Measures

Proportion of women with postpartum blood loss equal to or greater than 500 mL
Postpartum blood loss equal to or greater than 500 mL as measured in a plastic, calibrated container.

Secondary Outcome Measures

Mean postpartum blood loss
Mean blood loss as measured in a plastic, calibrated container.
Proportion of women with postpartum blood loss equal to or greater than 350 mL
Postpartum blood loss equal to or greater than 500 mL as measured in a plastic, calibrated container.
Proportion of women with postpartum blood loss equal to or greater than 1000 mL
Postpartum blood loss equal to or greater than 1000 mL as measured in a plastic, calibrated container.
Mean change in hemoglobin pre-delivery to postpartum
Hemoglobin will be measured in g/dL using the Hemocue machine. Pre-delivery hemoglobin will be taken during labor.
Time to delivery of placenta
Time interval in minutes between delivery of the baby and delivery of the placenta
Administration of additional oxytocin, other uterotonics or other interventions such as blood transfusion or hysterectomy
Side effects 1 hour postpartum

Full Information

First Posted
July 31, 2013
Last Updated
March 10, 2016
Sponsor
Gynuity Health Projects
Collaborators
El Galaa Teaching Hospital, University of Alexandria
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1. Study Identification

Unique Protocol Identification Number
NCT01914419
Brief Title
Oxytocin Via Intramuscular Injection and Intravenous Bolus or Infusion for Prevention of Postpartum Hemorrhage
Official Title
Administration of Oxytocin Via Intramuscular Injection and Intravenous Bolus or Intravenous Infusion in the Third Stage of Labor for Prevention of Postpartum Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynuity Health Projects
Collaborators
El Galaa Teaching Hospital, University of Alexandria

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study will evaluate whether prophylactic oxytocin administered in the third stage of labor via intravenous (IV) infusion or IV bolus reduces the rate of postpartum hemorrhage compared to intramuscular (IM) injection.
Detailed Description
The study will compare the effect of IV infusion or IV bolus to IM oxytocin administration with respect to mean blood loss and the proportion of women who experience blood loss greater than or equal to 500 ml, women who experience blood loss greater than or equal to 350 ml, side effects, adverse events and change in hemoglobin pre- to post-delivery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
Postpartum hemorrhage, Oxytocin, Prevention, Third stage of labor, Hemoglobin, Intravenous, Intramuscular, Bolus

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4983 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV infusion
Arm Type
Active Comparator
Arm Description
Oxytocin 10 IU will be administered by IV infusion according to randomization assignment as soon as possible after delivery of the baby.
Arm Title
IV bolus
Arm Type
Active Comparator
Arm Description
Oxytocin 10 IU will be administered by IV bolus according to randomization assignment as soon as possible after delivery of the baby.
Arm Title
IM injection
Arm Type
Active Comparator
Arm Description
Oxytocin 10 IU will be administered by IM injection according to randomization assignment as soon as possible after delivery of the baby.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Primary Outcome Measure Information:
Title
Proportion of women with postpartum blood loss equal to or greater than 500 mL
Description
Postpartum blood loss equal to or greater than 500 mL as measured in a plastic, calibrated container.
Time Frame
1 hour after delivery of baby
Secondary Outcome Measure Information:
Title
Mean postpartum blood loss
Description
Mean blood loss as measured in a plastic, calibrated container.
Time Frame
1 hour after delivery of the baby
Title
Proportion of women with postpartum blood loss equal to or greater than 350 mL
Description
Postpartum blood loss equal to or greater than 500 mL as measured in a plastic, calibrated container.
Time Frame
1 hour after delivery of the baby
Title
Proportion of women with postpartum blood loss equal to or greater than 1000 mL
Description
Postpartum blood loss equal to or greater than 1000 mL as measured in a plastic, calibrated container.
Time Frame
1 hour after delivery
Title
Mean change in hemoglobin pre-delivery to postpartum
Description
Hemoglobin will be measured in g/dL using the Hemocue machine. Pre-delivery hemoglobin will be taken during labor.
Time Frame
At least 12 hours after removal of IV and within 48 hours of delivery of the baby
Title
Time to delivery of placenta
Description
Time interval in minutes between delivery of the baby and delivery of the placenta
Time Frame
Within 1 hour of delivery of the baby
Title
Administration of additional oxytocin, other uterotonics or other interventions such as blood transfusion or hysterectomy
Time Frame
Within 1 hour of delivery of the baby
Title
Side effects 1 hour postpartum
Time Frame
1 hour after delivery of the baby

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All women who present in active labor for a live birth at the study hospital will be considered for participation in the study Exclusion Criteria: Planned or transferred for delivery via Cesarean section Administration of a pre-delivery uterotonic to induce or augment labor Unable to provide informed consent due to mental impairment, distress during labor or other reason
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
Rasha Dabash, MPH
Organizational Affiliation
Gynuity Health Projects
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ilana Dzuba, MHS
Organizational Affiliation
Gynuity Health Projects
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jill Durocher
Organizational Affiliation
Gynuity Health Projects
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dyanna Charles, MPH
Organizational Affiliation
Gynuity Health Projects
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shatby Maternity Hospital, Alexandria University
City
Alexandria
Country
Egypt
Facility Name
El Galaa Teaching Hospital
City
Cairo
Country
Egypt

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
PubMed Identifier
30658605
Citation
Charles D, Anger H, Dabash R, Darwish E, Ramadan MC, Mansy A, Salem Y, Dzuba IG, Byrne ME, Breebaart M, Winikoff B. Intramuscular injection, intravenous infusion, and intravenous bolus of oxytocin in the third stage of labor for prevention of postpartum hemorrhage: a three-arm randomized control trial. BMC Pregnancy Childbirth. 2019 Jan 18;19(1):38. doi: 10.1186/s12884-019-2181-2.
Results Reference
derived

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Oxytocin Via Intramuscular Injection and Intravenous Bolus or Infusion for Prevention of Postpartum Hemorrhage

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