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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4983 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postpartum Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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IV infusion

Oxytocin 10 IU will be administered by IV infusion according to randomization assignment as soon as possible after delivery of the baby.

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

IV bolus

Oxytocin 10 IU will be administered by IV bolus according to randomization assignment as soon as possible after delivery of the baby.

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

IM injection

Oxytocin 10 IU will be administered by IM injection according to randomization assignment as soon as possible after delivery of the baby.

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Interventions

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Oxytocin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes