NSAIDs for Preeclampsia (PANDA Trial)

Phase 2

Recruiting

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the end of hospitalization, up to 7 days after randomization

Awards & highlights

PANDA Trial Summary

This trial tests if adding nonsteroidal anti-inflammatory drugs to preeclampsia treatment helps prevent postpartum hypertension.

Who is the study for?

This trial is for women over 23 weeks pregnant at Barnes-Jewish Hospital diagnosed with severe preeclampsia, which includes very high blood pressure or issues like low platelets, liver problems, kidney trouble, lung fluid build-up, or persistent headaches. It's not for those who can't consent, have peptic ulcers or allergies to pain relievers used in the study, took certain blood pressure drugs early in pregnancy, have chronic kidney disease or a history of opioid abuse.Check my eligibility

What is being tested?

The study tests if adding nonsteroidal anti-inflammatory drugs (like Ibuprofen and Ketorolac) to standard pain relief methods after childbirth is just as good at managing high blood pressure as the usual treatment alone. Women will be randomly assigned to receive either the new combination of medications or the standard care.See study design

What are the potential side effects?

Possible side effects from NSAIDs may include stomach issues such as ulcers and bleeding; heartburn; potential kidney damage; increased risk of bleeding especially when combined with other medications affecting clotting; and rare allergic reactions.

PANDA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of hospitalization, up to 7 days after randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of hospitalization, up to 7 days after randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of hospitalization, up to 7 days after randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

postpartum antihypertensive requirements

Secondary outcome measures

Continued anti-hypertensive requirement

End organ damage

Hospital readmission

+3 more

PANDA Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: NSAID Analgesic bundleExperimental Treatment4 Interventions

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

Group II: NSAID free analgesic bundleActive Control2 Interventions

Acetaminophen 1000mg q 8 hrs as needed for pain, and Oxycodone 5 to 10 mg q 4 hrs as needed for pain.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acetaminophen

FDA approved

Ketorolac

FDA approved

Oxycodone

FDA approved