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

N/ACompletedNCT01914419

Gynuity Health Projects4,983 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

4,983

Conditions

Postpartum Hemorrhage

Interventions

OxytocinDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Shatby Maternity Hospital, Alexandria University

Alexandria, Egypt

El Galaa Teaching Hospital

Cairo, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 1 hour after delivery of baby

Secondary Outcomes

Mean postpartum blood loss

Mean blood loss as measured in a plastic, calibrated container.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: Within 1 hour of delivery of the baby

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

Data from ClinicalTrials.gov

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