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

Administration of Oxytocin Via Intramuscular Injection and Intravenous Bolus or Intravenous Infusion in the Third Stage of Labor for Prevention of Postpartum Hemorrhage

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 4983
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 hour after delivery of baby

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean postpartum blood loss	Mean blood loss as measured in a plastic, calibrated container.	1 hour after delivery of the baby
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.	1 hour after delivery of the baby
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.	1 hour after delivery
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.	At least 12 hours after removal of IV and within 48 hours of delivery of the baby
Time to delivery of placenta	Time interval in minutes between delivery of the baby and delivery of the placenta	Within 1 hour of delivery of the baby
Administration of additional oxytocin, other uterotonics or other interventions such as blood transfusion or hysterectomy		Within 1 hour of delivery of the baby
Side effects 1 hour postpartum		1 hour after delivery of the baby

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Collaborators: University of Alexandria; El Galaa Teaching Hospital
• Investigators: Principal Investigator: Jill Durocher, Gynuity Health Projects; Principal Investigator: Ilana Dzuba, MHS, Gynuity Health Projects; Principal Investigator: Dyanna Charles, MPH, Gynuity Health Projects

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: July 31, 2013
• First Submitted That Met QC Criteria: July 31, 2013
• First Posted (Estimate): August 2, 2013

Study Record Updates

• Last Update Posted (Estimate): March 11, 2016
• Last Update Submitted That Met QC Criteria: March 10, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Oxytocin; Prevention; Hemoglobin; Intravenous; Bolus; Postpartum hemorrhage; Intramuscular; Third stage of labor
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: 3000a