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.