Preeclampsia And Nonsteroidal Drugs for Analgesia: a Randomized Non Inferiority Trial (NCT03978767) | Clinical Trial Compass
CompletedPhase 2
Preeclampsia And Nonsteroidal Drugs for Analgesia: a Randomized Non Inferiority Trial
United States287 participantsStarted 2019-06-10
Plain-language 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.
Who can participate
SexFEMALE
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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.
What they're measuring
1
postpartum antihypertensive requirements
Timeframe: at the end of hospitalization, up to 7 days after randomization