Postpartum Hemorrhage Prevention in Patients With Preeclampsia (PHP3 Study)

University of Colorado Denver (CU Denver)

Status and phase: Completed; Early Phase 1

Conditions: Preeclampsia

Treatments: Drug: Oxytocin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02221830

13-2738

UL1TR001082 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 66 patients

Sex: Female

Ages: 13 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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66 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Normal Saline (standard of care)

Treatment:

Drug: Placebo

Treatment

Experimental group

Description:

normal saline + oxytocin

Treatment:

Drug: Oxytocin