Postpartum Hemorrhage Prevention in Patients With Preeclampsia (PHP3 Study)

Early Phase 1CompletedNCT02221830

University of Colorado, Denver66 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Preeclampsia

Interventions

OxytocinDRUG

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

PlaceboDRUG

This intervention utilizes a Placebo Camparator

Eligibility

Sex: FEMALEMin age: 13 YearsMax age: 45 Years

Medical Language ↔ Plain English

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) Exclusion Criteria: 1. abnormal placentation (previa, accreta, etc) 2. antenatal hemorrhage 3. contraindication to oxytocin

Locations (1)

University of Colorado Clinical and Translational Research Center

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Evaluation of Postpartum hematocrit

Postpartum hematocrit (collected 24 hours after delivery unless patient receives blood transfusion, then pre-transfusion hematocrit will be used)

Time frame: 24 hours postpartum

Secondary Outcomes

Primary postpartum hemorrhage

Considered to be \>500ml with vaginal deliveries,or, \>1000ml with cesarean sections.

Time frame: Before discharge from hospital

Estimated blood loss at delivery

Time frame: Before discharge from hospital

Postpartum blood loss

Postpartum blood loss: 24hrs postpartum, as measured by pad counts and weights.

Time frame: 24 hours postpartum

Data from ClinicalTrials.gov

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