Overview

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

Status:
Recruiting
Trial end date:
2022-07-27
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Washington University School of Medicine
Treatments:
Acetaminophen
Analgesics
Anti-Inflammatory Agents, Non-Steroidal
Ibuprofen
Ketorolac
Ketorolac Tromethamine
Oxycodone
Criteria
Inclusion Criteria:

- 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.

Exclusion Criteria:

- NSAID allergy

- Allergy to acetaminophen

- Antihypertensive use in this pregnancy prior to 20 weeks gestation

- Chronic kidney disease or Acute kidney injury with Creatine clearance less than 60
mL/min

- Inability to obtain consent

- Opioid abuse disorder

- Peptic ulcer disease.