Postpartum Hemorrhage Prevention in Patients With Preeclampsia (PHP3 Study)

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

EARLY_PHASE1

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2019-07-17

Brief Summary

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Evaluation of the efficacy of postpartum 24 hour oxytocin infusion to reduce blood loss in patients with pre-eclampsia (PE)

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Detailed Description

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The overall goal of this study is to evaluate the efficacy of postpartum 24 hour oxytocin infusion as a prevention-oriented strategy to reduce blood loss in patients with pre-eclampsia (PE) in a blinded, placebo controlled, randomized controlled trial.

Conditions

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Preeclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Normal Saline (standard of care)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

This intervention utilizes a Placebo Camparator

Treatment

normal saline + oxytocin

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

Our intervention simply replaces the standardly given normal saline with treatment (normal saline + oxytocin)

Interventions

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Oxytocin

Our intervention simply replaces the standardly given normal saline with treatment (normal saline + oxytocin)

Intervention Type DRUG

Placebo

This intervention utilizes a Placebo Camparator

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. vaginal or cesarean delivery at a gestational age greater than or equal to 20 weeks gestational age;
2. diagnosis of preeclampsia (PE defined using standard definitions based on the ACOG bulletin and the NIH Working Group on High Blood Pressure in Pregnancy (i.e., a systolic blood pressure greater than 140 mm Hg or a diastolic blood pressure greater than 90 mm Hg on at least 2 occasions at least 6 hours apart after 20 weeks gestation and proteinuria of \> 300mg per 24 hour period or \> 1+ on dipstick).
3. patients treated with magnesium sulfate for 24 hours post partum at 2g/hr (standard of care when deemed appropriate by clinician for seizure prophylaxis)