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

NCT03978767 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 287

Last updated 2025-12-31

No results posted yet for this study

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.

Conditions

  • Preeclampsia Severe
  • Preeclampsia Postpartum

Interventions

DRUG

Ibuprofen 600 mg

NSAID pain medication to be used in the experimental bundle for postpartum analgesia

DRUG

Ketorolac

NSAID analgesic to be used in the experimental bundle for postpartum analgesia in patients who underwent cesarean section

DRUG

Acetaminophen

Analgesic medication to be used in both treatment arms

DRUG

Oxycodone

Analgesic medication to be used in both treatment arms

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-10
Primary Completion
2025-07-31
Completion
2025-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03978767 on ClinicalTrials.gov