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

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

Study Overview

• Status: Completed
• Conditions: Preeclampsia
• Intervention / Treatment: Drug: Placebo; Drug: Oxytocin

Detailed Description

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
• Enrollment (Actual): 66
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Clinical and Translational Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Amy Hermesch, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): July 17, 2019
• Study Completion (Actual): July 17, 2019

Study Registration Dates

• First Submitted: August 19, 2014
• First Submitted That Met QC Criteria: August 19, 2014
• First Posted (Estimate): August 20, 2014

Study Record Updates

• Last Update Posted (Actual): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 4, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Hypertension, Pregnancy-Induced; Uterine Hemorrhage; Hemorrhage; Pre-Eclampsia; Postpartum Hemorrhage; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: 13-2738; UL1TR001082 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No