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IV vs IM Oxytocin in the Third Stage of Labor for Prevention of Postpartum Hemorrhage

Primary Purpose

Postpartum Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Oxytocin
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, Third stage of labor, Hemoglobin, Prevention, Intravenous, Intramuscular

Eligibility Criteria

undefined - undefined (Child, Adult, Older 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: Women who are:

  • Planned or transferred for delivery via Cesarean section
  • Not delivering a live birth
  • Unable to provide informed consent due to mental impairment, distress during labor or other reason
  • Unwilling and/or unable to respond to questionnaires about background characteristics and/or bleeding history.

Sites / Locations

  • Hospital Gineco-Obstétrico Isidro Ayora
  • SB Etlik Zübeyde Hanım Kadın Hastalıkları Eğitim ve Araştırma Hastanesi
  • Huong Vuong Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

IV infusion

IM Injection

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mean blood loss (ml)

Secondary Outcome Measures

Proportion of women who bleed greater or equal to 350 ml, 500 ml and 1000 ml
Change in hemoglobin from pre-delivery to postpartum
Post-delivery hemoglobin using a Hemocue® Hemoglobin machine + cuvette will be taken at least 24 after delivery and before the woman leaves the facility. If the woman has received IV fluids, hemoglobin will be measured at least 12 hours after removal of the IV prior to discharge.
Time to placental delivery
Administration of additional oxytocin, other uterotonics, or other interventions such as blood transfusion and hysterectomy
Side effects 1 hour postpartum
Bleeding scores calculated from a standardized questionnaire administered on arrival to labor ward

Full Information

First Posted
May 29, 2012
Last Updated
March 25, 2016
Sponsor
Gynuity Health Projects
Collaborators
Center for Research and Consultancy in Reproductive Health, Huong Vuong Hospital, MOH Etlik Zubeyde Hanim Women's Health Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01608958
Brief Title
IV vs IM Oxytocin in the Third Stage of Labor for Prevention of Postpartum Hemorrhage
Official Title
Intravenous and Intramuscular Administration of Oxytocin in the Third Stage of Labor for Prevention of Postpartum Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynuity Health Projects
Collaborators
Center for Research and Consultancy in Reproductive Health, Huong Vuong Hospital, MOH Etlik Zubeyde Hanim Women's Health Training and Research Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study will evaluate whether prophylactic oxytocin administered in the third stage of labor via IV infusion results in a lower mean blood loss compared to IM injection.
Detailed Description
The study will compare the effect of IV infusion and IM oxytocin administration on the proportion of women who experience blood loss greater than or equal t 350 ml, the proportion of women who experience blood loss greater than or equal to 500 ml, side effects, adverse events and change in hemoglobin pre- to post-delivery. It will also assess whether a bleeding history questionnaire can identify women at risk for excessive bleeding and help to define the distribution of bleeding scores among women with and without excessive bleeding.

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, Third stage of labor, Hemoglobin, Prevention, Intravenous, Intramuscular

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
IV infusion
Arm Type
Active Comparator
Arm Description
Oxytocin 10 IU will be administered IV infusion 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 IM according to randomization assignment as soon as possible after delivery of the baby.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Description
10 IU oxytocin in 500 ml infusion
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Description
10 IU oxytocin IM injection
Primary Outcome Measure Information:
Title
Mean blood loss (ml)
Time Frame
minimum of 1 hour after delivery of baby
Secondary Outcome Measure Information:
Title
Proportion of women who bleed greater or equal to 350 ml, 500 ml and 1000 ml
Time Frame
minimum of 1 hour after delivery of baby
Title
Change in hemoglobin from pre-delivery to postpartum
Description
Post-delivery hemoglobin using a Hemocue® Hemoglobin machine + cuvette will be taken at least 24 after delivery and before the woman leaves the facility. If the woman has received IV fluids, hemoglobin will be measured at least 12 hours after removal of the IV prior to discharge.
Time Frame
12-24 hours after delivery
Title
Time to placental delivery
Time Frame
minimum of 1 hour after delivery of baby
Title
Administration of additional oxytocin, other uterotonics, or other interventions such as blood transfusion and hysterectomy
Time Frame
minimum of 1 hour after delivery of baby
Title
Side effects 1 hour postpartum
Time Frame
1 hour postpartum
Title
Bleeding scores calculated from a standardized questionnaire administered on arrival to labor ward
Time Frame
arrival to labor ward

10. Eligibility

Sex
Female
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: Women who are: Planned or transferred for delivery via Cesarean section Not delivering a live birth Unable to provide informed consent due to mental impairment, distress during labor or other reason Unwilling and/or unable to respond to questionnaires about background characteristics and/or bleeding history.
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, 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
Jennifer Blum, MPH
Organizational Affiliation
Gynuity Health Projects
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Gineco-Obstétrico Isidro Ayora
City
Quito
Country
Ecuador
Facility Name
SB Etlik Zübeyde Hanım Kadın Hastalıkları Eğitim ve Araştırma Hastanesi
City
Ankara
Country
Turkey
Facility Name
Huong Vuong Hospital
City
Ho Chi Minh City
Country
Vietnam

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

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IV vs IM Oxytocin in the Third Stage of Labor for Prevention of Postpartum Hemorrhage

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