Preeclampsia And Nonsteroidal Drugs for Analgesia (PANDA): a Randomized Non Inferiority Trial

Who is this study for? Patients with preeclampsia
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

A randomized non-inferiority trial of women with preeclampsia with severe features to determine if the addition of nonsteroidal anti-inflammatory drugs is inferior or non-inferior to standard analgesic bundles in their impact on postpartum hypertension.

Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:

• Women at \> 23 weeks gestational age undergoing vaginal or cesarean delivery at Barnes-Jewish Hospital with:

• An antepartum diagnosis of preeclampsia with severe features

• Pre-eclampsia with severe features will be defined as:

• Elevated blood pressure ≥ 160/110, or

• Pre-eclampsia in the setting of thrombocytopenia (platelet count \< 100,000), or

• Impaired liver function (AST elevated to twice upper limit of normal), or

• Persistent epigastric pain, or

• Renal insufficiency (serum creatinine of 1.1 mg/dl or doubling of prior value), or

• Pulmonary edema, or

• New onset visual disturbance or headache unresponsive to therapy.

Locations
United States
Missouri
Barnes Jewish Hospital
RECRUITING
St Louis
Contact Information
Primary
Jonathan S Hirshberg, MD
jhirshberg@wustl.edu
314-362-5000
Backup
Tracy Burger
tburger@wustl.edu
3147471390
Time Frame
Start Date: 2019-06-10
Estimated Completion Date: 2025-06-01
Participants
Target number of participants: 286
Treatments
Experimental: NSAID Analgesic bundle
Ibuprofen 600mg PO q 6 hrs as needed for pain, Acetaminophen 1000mg q 8 hrs as needed for pain, and Oxycodone 5 to 10 mg q 4 hrs as needed for pain. In patients undergoing cesarean section, ketorolac 30mg IV q 6 hrs may be substituted as an IV alternative to ibuprofen for the first 24 hours after surgery
Active_comparator: NSAID free analgesic bundle
Acetaminophen 1000mg q 8 hrs as needed for pain, and Oxycodone 5 to 10 mg q 4 hrs as needed for pain.
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine

This content was sourced from clinicaltrials.gov