Trial record 16 of 750 for:    Open Studies | "Hemorrhage"

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

This study is not yet open for participant recruitment.
Verified November 2013 by Gynuity Health Projects
Sponsor:
Collaborators:
El Galaa Teaching Hospital, Cairo, Egypt
Faculty of Medicine, University of Alexandria
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT01914419
First received: July 31, 2013
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Postpartum Hemorrhage
Drug: Oxytocin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Proportion of women with postpartum blood loss equal to or greater than 500 mL [ Time Frame: 1 hour after delivery of baby ] [ Designated as safety issue: No ]
    Postpartum blood loss equal to or greater than 500 mL as measured in a plastic, calibrated container.


Secondary Outcome Measures:
  • Mean postpartum blood loss [ Time Frame: 1 hour after delivery of the baby ] [ Designated as safety issue: No ]
    Mean blood loss as measured in a plastic, calibrated container.

  • Proportion of women with postpartum blood loss equal to or greater than 350 mL [ Time Frame: 1 hour after delivery of the baby ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 hour after delivery ] [ Designated as safety issue: No ]
    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 [ Time Frame: At least 12 hours after removal of IV and within 48 hours of delivery of the baby ] [ Designated as safety issue: No ]
    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 Frame: Within 1 hour of delivery of the baby ] [ Designated as safety issue: No ]
    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 [ Time Frame: Within 1 hour of delivery of the baby ] [ Designated as safety issue: No ]
  • Side effects 1 hour postpartum [ Time Frame: 1 hour after delivery of the baby ] [ Designated as safety issue: No ]

Estimated Enrollment: 4900
Study Start Date: January 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IV infusion
Oxytocin 10 IU will be administered by IV infusion according to randomization assignment as soon as possible after delivery of the baby.
Drug: Oxytocin
Active Comparator: IV bolus
Oxytocin 10 IU will be administered by IV bolus according to randomization assignment as soon as possible after delivery of the baby.
Drug: Oxytocin
Active Comparator: IM injection
Oxytocin 10 IU will be administered by IM injection according to randomization assignment as soon as possible after delivery of the baby.
Drug: Oxytocin

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
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:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01914419

Contacts
Contact: Rasha Dabash, MPH 212-448-1230 rdabash@gynuity.org
Contact: Holly A Anger, MPH 212-448-1230 hanger@gynuity.org

Locations
Egypt
Shatby Maternity Hospital, Alexandria University Not yet recruiting
Alexandria, Egypt
Contact: Emad Darwish, MD    2034860665    edarwish@hotmail.com   
Principal Investigator: Emad Darwish, MD         
El Galaa Teaching Hospital Not yet recruiting
Cairo, Egypt
Contact: Mohammed Cherine Ramadan, MD    2023387667    mshereen57@yahoo.com   
Principal Investigator: Mohammed Cherine Ramadan, MD         
Sponsors and Collaborators
Gynuity Health Projects
El Galaa Teaching Hospital, Cairo, Egypt
Faculty of Medicine, University of Alexandria
Investigators
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
Principal Investigator: Rasha Dabash, 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: NCT01914419     History of Changes
Other Study ID Numbers: 3000a
Study First Received: July 31, 2013
Last Updated: November 20, 2013
Health Authority: Egypt: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 14, 2014