Postpartum Hemorrhage Prevention in Patients With Preeclampsia (PHP3 Study)

Early Phase 1

Completed

• Conditions: Preeclampsia
• Interventions: Drug: Placebo; Drug: Oxytocin

• Registration Number: NCT02221830
• Lead Sponsor: 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)

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 Timeline

• Study First Submitted: 2014-08-19
• Study First Submitted QC: 2014-08-19
• Study First Posted: 2014-08-20
• Study Start: 2015-02
• Primary Completion: 2019-07-17
• Study Completion: 2019-07-17
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-04
• Last Update Posted: 2021-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Normal Saline (standard of care)
Treatment	Oxytocin	normal saline + oxytocin

Primary Outcome Measures

Name	Time	Method
Evaluation of Postpartum hematocrit	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

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

Trial Locations

Locations (1)

University of Colorado Clinical and Translational Research Center; 🇺🇸 Aurora, Colorado, United States