Postpartum Hemorrhage Prevention in Patients With Preeclampsia (PHP3 Study)

Preeclampsia Clinical Trial

— PHP3  

Official title:

Postpartum Hemorrhage Prevention in Patients With Preeclampsia (PHP3 Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02221830
• Other study ID #: 13-2738
• Secondary ID: UL1TR001082
• Status: Completed
• Phase: Early Phase 1
• Start date: February 2015
• Est. completion date: July 17, 2019

Study information

• Verified date: May 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 17, 2019
• Est. primary completion date: July 17, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage
• Pre-Eclampsia
• Preeclampsia

Intervention

Drug:
• Oxytocin
Our intervention simply replaces the standardly given normal saline with treatment (normal saline + oxytocin)
• Placebo
This intervention utilizes a Placebo Camparator

Locations

Country	Name	City	State
United States	University of Colorado Clinical and Translational Research Center	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

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