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

Primary Purpose

Preeclampsia

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oxytocin
Placebo
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preeclampsia

Eligibility Criteria

13 Years - 45 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado Clinical and Translational Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Treatment

Arm Description

Normal Saline (standard of care)

normal saline + oxytocin

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Primary postpartum hemorrhage
Considered to be >500ml with vaginal deliveries,or, >1000ml with cesarean sections.
Estimated blood loss at delivery
Estimated blood loss at delivery
Postpartum blood loss
Postpartum blood loss: 24hrs postpartum, as measured by pad counts and weights.

Full Information

First Posted
August 19, 2014
Last Updated
May 4, 2021
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT02221830
Brief Title
Postpartum Hemorrhage Prevention in Patients With Preeclampsia (PHP3 Study)
Acronym
PHP3
Official Title
Postpartum Hemorrhage Prevention in Patients With Preeclampsia (PHP3 Study)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
July 17, 2019 (Actual)
Study Completion Date
July 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal Saline (standard of care)
Arm Title
Treatment
Arm Type
Experimental
Arm Description
normal saline + oxytocin
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Description
Our intervention simply replaces the standardly given normal saline with treatment (normal saline + oxytocin)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
This intervention utilizes a Placebo Camparator
Primary Outcome Measure Information:
Title
Evaluation of Postpartum hematocrit
Description
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 Outcome Measure Information:
Title
Primary postpartum hemorrhage
Description
Considered to be >500ml with vaginal deliveries,or, >1000ml with cesarean sections.
Time Frame
Before discharge from hospital
Title
Estimated blood loss at delivery
Description
Estimated blood loss at delivery
Time Frame
Before discharge from hospital
Title
Postpartum blood loss
Description
Postpartum blood loss: 24hrs postpartum, as measured by pad counts and weights.
Time Frame
24 hours postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Hermesch, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Clinical and Translational Research Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

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Postpartum Hemorrhage Prevention in Patients With Preeclampsia (PHP3 Study)

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