Postpartum Hemorrhage Prevention in Patients With Preeclampsia (PHP3 Study)

Study Overview
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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)

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.

Official Title
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Postpartum Hemorrhage Prevention in Patients With Preeclampsia (PHP3 Study)

Conditions
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Preeclampsia

Intervention / Treatment
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* Drug: Oxytocin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: vaginal or cesarean delivery at a gestational age greater than or equal to 20 weeks gestational age; 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). 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: abnormal placentation (previa, accreta, etc) antenatal hemorrhage contraindication to oxytocin

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Normal Saline (standard of care) | Drug: Placebo<br>* This intervention utilizes a Placebo Camparator<br>|
| Experimental: Treatment<br>normal saline + oxytocin | Drug: Oxytocin<br>* Our intervention simply replaces the standardly given normal saline with treatment (normal saline + oxytocin)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Postpartum hematocrit | Postpartum hematocrit (collected 24 hours after delivery unless patient receives blood transfusion, then pre-transfusion hematocrit will be used) | 24 hours postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary postpartum hemorrhage | Considered to be >500ml with vaginal deliveries,or, >1000ml with cesarean sections. | Before discharge from hospital | 
| Estimated blood loss at delivery | Estimated blood loss at delivery | Before discharge from hospital | 
| Postpartum blood loss | Postpartum blood loss: 24hrs postpartum, as measured by pad counts and weights. | 24 hours postpartum |