Preeclampsia
Conditions
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.
Interventions
DRUGOxytocin
Our intervention simply replaces the standardly given normal saline with treatment (normal saline + oxytocin)
DRUGPlacebo
This intervention utilizes a Placebo Camparator
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
13 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed