What is the mechanism of action of this treatment?

Low-dose aspirin is commonly used to prevent pre-eclampsia by inhibiting cyclooxygenase enzymes, which reduces thromboxane production, thereby decreasing platelet aggregation and vasoconstriction. This improves placental blood flow and lowers the risk of pre-eclampsia. NSAIDs, which also inhibit cyclooxygenase enzymes, are mainly used for pain management in pre-eclampsia patients. Understanding these mechanisms is important for selecting treatments that can effectively reduce the risks and complications associated with pre-eclampsia.

What side effects are associated with this type of intervention?

Common treatments for pre-eclampsia, such as NSAIDs, are associated with several side effects. These include gastrointestinal bleeding, renal disease, and cardiovascular events. In pregnancy, NSAIDs should be avoided after 30 weeks due to the risk of premature closure of the fetal ductus arteriosus and oligohydramnios. Given these risks, NSAID use in pre-eclampsia should be approached with caution and under strict medical supervision.

What prior FDA approvals exist?

There is no specific mention of FDA approvals for the treatment of preeclampsia using NSAIDs or cyclooxygenase inhibitors in the provided context. However, celecoxib, a COX-2 selective inhibitor, has been studied for its potential benefits in improving maternal and fetal outcomes in preeclampsia-like conditions in animal models. The context also discusses the general use of NSAIDs in managing inflammation and pain, which could be relevant to preeclampsia treatment strategies.

What other types of research exist?

Promising novel alternatives to NSAIDs for pre-eclampsia patients include NO-naproxen and nitrooxy-acyl derivatives of salicylic acid. These alternatives show reduced gastrointestinal toxicity and effective anti-inflammatory properties, making them potentially safer options for treatment.

← Back to Search

Opioid Analgesic

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

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Summary

This trial is testing whether using common painkillers like ibuprofen after childbirth is safe for women who had severe high blood pressure during pregnancy. The study aims to see if these painkillers make their condition worse. Researchers hope to find out if these drugs can be safely used to reduce the need for stronger pain medications like opioids. Ibuprofen is a widely used nonsteroidal anti-inflammatory drug (NSAID) commonly prescribed for pain relief and inflammation.

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

postpartum antihypertensive requirements

Secondary study objectives

Continued anti-hypertensive requirement

End organ damage

Hospital readmission

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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

Ibuprofen

FDA approved

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Low-dose aspirin is commonly used to prevent pre-eclampsia by inhibiting cyclooxygenase enzymes, which reduces thromboxane production, thereby decreasing platelet aggregation and vasoconstriction. This improves placental blood flow and lowers the risk of pre-eclampsia. NSAIDs, which also inhibit cyclooxygenase enzymes, are mainly used for pain management in pre-eclampsia patients. Understanding these mechanisms is important for selecting treatments that can effectively reduce the risks and complications associated with pre-eclampsia.

Preeclampsia-Pathophysiology and Clinical Presentations: JACC State-of-the-Art Review.Pre-eclampsia screening in the first trimester - preemptive action to prevent the peril.Hypertension in pregnancy.