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

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ClinicalTrials.gov Identifier: NCT02221830
Recruitment Status : Recruiting
First Posted : August 20, 2014
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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

Condition or disease Intervention/treatment Phase
Preeclampsia Drug: Oxytocin Drug: Placebo Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Postpartum Hemorrhage Prevention in Patients With Preeclampsia (PHP3 Study)
Study Start Date : February 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

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)




Primary Outcome Measures :
  1. Evaluation of Postpartum hematocrit [ Time Frame: 24 hours postpartum ]
    Postpartum hematocrit (collected 24 hours after delivery unless patient receives blood transfusion, then pre-transfusion hematocrit will be used)


Secondary Outcome Measures :
  1. Primary postpartum hemorrhage [ Time Frame: Before discharge from hospital ]
    Considered to be >500ml with vaginal deliveries,or, >1000ml with cesarean sections.

  2. Estimated blood loss at delivery [ Time Frame: Before discharge from hospital ]
    Estimated blood loss at delivery

  3. Postpartum blood loss [ Time Frame: 24 hours postpartum ]
    Postpartum blood loss: 24hrs postpartum, as measured by pad counts and weights.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221830


Contacts
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Contact: Amy Hermesch, MD 303-724-2038 amy.hermesch@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Clinical and Translational Research Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Amy Hermesch, MD    303-724-2038    amy.hermesch@ucdenver.edu   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Amy Hermesch, MD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02221830     History of Changes
Other Study ID Numbers: 13-2738
UL1TR001082 ( U.S. NIH Grant/Contract )
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Puerperal Disorders
Uterine Hemorrhage
Pre-Eclampsia
Pathologic Processes
Hypertension, Pregnancy-Induced
Pregnancy Complications
Obstetric Labor Complications
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs