IV vs IM Oxytocin in the Third Stage of Labor for Prevention of Postpartum Hemorrhage

Gynuity Health Projects653 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

653

Conditions

Postpartum Hemorrhage

Interventions

OxytocinDRUG

10 IU oxytocin in 500 ml infusion

OxytocinDRUG

10 IU oxytocin IM injection

Eligibility

Sex: FEMALEHealthy 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: 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.

Locations (3)

Hospital Gineco-Obstétrico Isidro Ayora

Quito, Ecuador

SB Etlik Zübeyde Hanım Kadın Hastalıkları Eğitim ve Araştırma Hastanesi

Ankara, Turkey (Türkiye)

Huong Vuong Hospital

Ho Chi Minh City, Vietnam

Outcomes

Primary Outcomes

Mean blood loss (ml)

Time frame: minimum of 1 hour after delivery of baby

Secondary Outcomes

Proportion of women who bleed greater or equal to 350 ml, 500 ml and 1000 ml

Time frame: minimum of 1 hour after delivery of baby

Change in hemoglobin from pre-delivery to postpartum

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 frame: 12-24 hours after delivery

Time to placental delivery

Time frame: minimum of 1 hour after delivery of baby

Administration of additional oxytocin, other uterotonics, or other interventions such as blood transfusion and hysterectomy

Time frame: minimum of 1 hour after delivery of baby

Side effects 1 hour postpartum

Time frame: 1 hour postpartum

Bleeding scores calculated from a standardized questionnaire administered on arrival to labor ward

Time frame: arrival to labor ward

Data from ClinicalTrials.gov

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