Comparing NSAIDs and standard pain relief for women with severe preeclampsia
Preeclampsia And Nonsteroidal Drugs for Analgesia (PANDA): a Randomized Non Inferiority Trial
This study tests if adding pain relief medications like ibuprofen can help women with severe preeclampsia manage high blood pressure after giving birth just as well as standard pain relief methods.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 286 (estimated) |
| Sex | Female |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (Saint Louis, Missouri) |
| Trial ID | NCT03978767 on ClinicalTrials.gov |
What this trial studies
This trial investigates whether the addition of nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen is non-inferior to standard analgesic protocols in managing postpartum hypertension in women with severe preeclampsia. The study will randomly assign participants to receive either NSAIDs or a control group without them, aiming to gather data on the safety and efficacy of NSAID use in this specific patient population. The trial addresses a gap in current obstetric literature regarding the impact of NSAIDs on postpartum hypertension, especially in the context of the opioid crisis and the need for effective non-opioid pain management.
Who should consider this trial
Good fit: Ideal candidates are women over 23 weeks gestational age with an antepartum diagnosis of severe preeclampsia undergoing vaginal or cesarean delivery.
Not a fit: Patients with NSAID allergies, chronic kidney disease, or those who have used antihypertensives prior to 20 weeks gestation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective pain management option for women with severe preeclampsia, potentially reducing reliance on opioids.
How similar studies have performed: While there is limited data specifically addressing NSAID use in postpartum preeclampsia, the approach of evaluating non-opioid analgesics is gaining traction amidst the opioid crisis, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Saint Louis, Missouri
- Barnes Jewish Hospital — Saint Louis, Missouri, United States (Recruiting)
Study contacts
- Study coordinator: Jonathan S Hirshberg, MD
- Email: jhirshberg@wustl.edu
- Phone: 314-362-5000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.