Intravenous and Intramuscular Administration of Oxytocin in the Third Stage of Labor for Prevention of Postpartum Hemorrhage

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Center for Research and Consultancy in Reproductive Health, Ho Chi Minh City, Vietnam
Huong Vuong Hospital; Ho Chi Minh City, Vietnam
Hospital Gineco-Obstétrico Isidro Ayora; Quito, Ecuador
SB Etlik Zübeyde Hanım Kadın Hastalıkları Eğitim ve Araştırma Hastanesi; Ankara, Turkey
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT01608958
First received: May 29, 2012
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Postpartum Hemorrhage
Drug: Oxytocin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Intravenous and Intramuscular Administration of Oxytocin in the Third Stage of Labor for Prevention of Postpartum Hemorrhage

Resource links provided by NLM:


Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Mean blood loss (ml) [ Time Frame: minimum of 1 hour after delivery of baby ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of women who bleed greater or equal to 350 ml, 500 ml and 1000 ml [ Designated as safety issue: No ]
  • Change in hemoglobin from pre-delivery to postpartum [ Time Frame: 12-24 hours after delivery ] [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
  • Administration of additional oxytocin, other uterotonics, or other interventions such as blood transfusion and hysterectomy [ Designated as safety issue: No ]
  • Side effects 1 hour postpartum [ Time Frame: 1 hour postpartum ] [ Designated as safety issue: No ]
  • Bleeding scores calculated from a standardized questionnaire administered on arrival to labor ward [ Designated as safety issue: No ]

Estimated Enrollment: 644
Study Start Date: May 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IV infusion
Oxytocin 10 IU will be administered IV infusion according to randomization assignment as soon as possible after delivery of the baby.
Drug: Oxytocin
10 IU oxytocin in 500 ml infusion
Active Comparator: IM Injection
Oxytocin 10 IU will be administered IM according to randomization assignment as soon as possible after delivery of the baby.
Drug: Oxytocin
10 IU oxytocin 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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608958

Locations
Ecuador
Hospital Gineco-Obstétrico Isidro Ayora
Quito, Ecuador
Turkey
SB Etlik Zübeyde Hanım Kadın Hastalıkları Eğitim ve Araştırma Hastanesi
Ankara, Turkey
Vietnam
Huong Vuong Hospital
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
Gynuity Health Projects
Center for Research and Consultancy in Reproductive Health, Ho Chi Minh City, Vietnam
Huong Vuong Hospital; Ho Chi Minh City, Vietnam
Hospital Gineco-Obstétrico Isidro Ayora; Quito, Ecuador
SB Etlik Zübeyde Hanım Kadın Hastalıkları Eğitim ve Araştırma Hastanesi; Ankara, Turkey
Investigators
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
Principal Investigator: Ilana Dzuba, MHS Gynuity Health Projects
Principal Investigator: Jill Durocher Gynuity Health Projects
Principal Investigator: Jennifer Blum, MPH Gynuity Health Projects
  More Information

No publications provided

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01608958     History of Changes
Other Study ID Numbers: 3000
Study First Received: May 29, 2012
Last Updated: February 18, 2014
Health Authority: Vietnam: Institutional Review Board

Keywords provided by Gynuity Health Projects:
Postpartum hemorrhage
Oxytocin
Third stage of labor
Hemoglobin
Prevention
Intravenous
Intramuscular

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 21, 2014