Skip to main content
OpenTrials
Completed

NCT Number: NCT02221830

Postpartum Hemorrhage Prevention in Patients With Preeclampsia (PHP3 Study)

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

13 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Colorado Clinical and Translational Research Center

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxytocin

Drug

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

Placebo

Drug

This intervention utilizes a Placebo Camparator

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Acronym: PHP3

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Aug 20, 2014
Registry last updated
May 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.