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

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ClinicalTrials.gov Identifier: NCT01914419
Recruitment Status : Completed
First Posted : August 2, 2013
Last Update Posted : March 11, 2016
Sponsor:
Collaborators:
El Galaa Teaching Hospital
Faculty of Medicine, University of Alexandria
Information provided by (Responsible Party):
Gynuity Health Projects

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.

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Drug: Oxytocin Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4983 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Proportion of women with postpartum blood loss equal to or greater than 500 mL [ Time Frame: 1 hour after delivery of baby ]
    Postpartum blood loss equal to or greater than 500 mL as measured in a plastic, calibrated container.


Secondary Outcome Measures :
  1. Mean postpartum blood loss [ Time Frame: 1 hour after delivery of the baby ]
    Mean blood loss as measured in a plastic, calibrated container.

  2. Proportion of women with postpartum blood loss equal to or greater than 350 mL [ Time Frame: 1 hour after delivery of the baby ]
    Postpartum blood loss equal to or greater than 500 mL as measured in a plastic, calibrated container.

  3. Proportion of women with postpartum blood loss equal to or greater than 1000 mL [ Time Frame: 1 hour after delivery ]
    Postpartum blood loss equal to or greater than 1000 mL as measured in a plastic, calibrated container.

  4. 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 ]
    Hemoglobin will be measured in g/dL using the Hemocue machine. Pre-delivery hemoglobin will be taken during labor.

  5. Time to delivery of placenta [ Time Frame: Within 1 hour of delivery of the baby ]
    Time interval in minutes between delivery of the baby and delivery of the placenta

  6. 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 ]
  7. Side effects 1 hour postpartum [ Time Frame: 1 hour after delivery of the baby ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01914419


Locations
Egypt
Shatby Maternity Hospital, Alexandria University
Alexandria, Egypt
El Galaa Teaching Hospital
Cairo, Egypt
Sponsors and Collaborators
Gynuity Health Projects
El Galaa Teaching Hospital
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: Dyanna Charles, MPH Gynuity Health Projects

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01914419     History of Changes
Other Study ID Numbers: 3000a
First Posted: August 2, 2013    Key Record Dates
Last Update Posted: March 11, 2016
Last Verified: February 2016

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
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs