IV vs IM Oxytocin in the Third Stage of Labor 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

653 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postpartum Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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IV infusion

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

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

10 IU oxytocin in 500 ml infusion

IM Injection

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

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

10 IU oxytocin IM injection

Interventions

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Oxytocin

10 IU oxytocin in 500 ml infusion

Intervention Type DRUG

Oxytocin

10 IU oxytocin IM injection

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
* 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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes