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

NCT03978767 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 201901202
• Study Type: interventional
• Target: 287
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

NSAIDs; Ibuprofen

Outcome Measures

Primary Outcomes (1)

• postpartum antihypertensive requirements

  measurement of anti-hypertensive requirements at time of discharge

  at the end of hospitalization, up to 7 days after randomization

Secondary Outcomes (6)

• Postpartum pain scores

  From randomization to 6 weeks after randomization

• Postpartum opioid use

  From randomization to 6 weeks after randomization

• Mean arterial blood pressure

  From randomization to 6 weeks after randomization

• End organ damage

  during hospitalization, an average of 4 days

• Hospital readmission

  From randomization to 6 weeks after randomization

Study Arms (2)

NSAID Analgesic bundle

EXPERIMENTAL

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

Drug: Ibuprofen 600 mg; Drug: Ketorolac; Drug: Acetaminophen; Drug: Oxycodone

NSAID free analgesic bundle

ACTIVE COMPARATOR

Acetaminophen 1000mg q 8 hrs as needed for pain, and Oxycodone 5 to 10 mg q 4 hrs as needed for pain.

Drug: Acetaminophen; Drug: Oxycodone

Interventions

Ibuprofen 600 mg DRUG

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

NSAID Analgesic bundle

Ketorolac DRUG

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

NSAID Analgesic bundle

Acetaminophen DRUG

Analgesic medication to be used in both treatment arms

NSAID Analgesic bundle; NSAID free analgesic bundle

Oxycodone DRUG

Analgesic medication to be used in both treatment arms

NSAID Analgesic bundle; NSAID free analgesic bundle

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (5)

• Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.

  PMID: 24150027 BACKGROUND

• Lo JO, Mission JF, Caughey AB. Hypertensive disease of pregnancy and maternal mortality. Curr Opin Obstet Gynecol. 2013 Apr;25(2):124-32. doi: 10.1097/GCO.0b013e32835e0ef5.

  PMID: 23403779 BACKGROUND

• Sibai B, Dekker G, Kupferminc M. Pre-eclampsia. Lancet. 2005 Feb 26-Mar 4;365(9461):785-99. doi: 10.1016/S0140-6736(05)17987-2.

  PMID: 15733721 BACKGROUND

• Mogos MF, Salemi JL, Spooner KK, McFarlin BL, Salihu HH. Hypertensive disorders of pregnancy and postpartum readmission in the United States: national surveillance of the revolving door. J Hypertens. 2018 Mar;36(3):608-618. doi: 10.1097/HJH.0000000000001594.

  PMID: 29045342 BACKGROUND

• Viteri OA, England JA, Alrais MA, Lash KA, Villegas MI, Ashimi Balogun OA, Chauhan SP, Sibai BM. Association of Nonsteroidal Antiinflammatory Drugs and Postpartum Hypertension in Women With Preeclampsia With Severe Features. Obstet Gynecol. 2017 Oct;130(4):830-835. doi: 10.1097/AOG.0000000000002247.

  PMID: 28885417 BACKGROUND

MeSH Terms

Interventions

Ibuprofen; Ketorolac; Acetaminophen; Oxycodone

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized non-inferiority clinical trial

Study Record Dates

• First Submitted: May 18, 2019
• First Posted: June 7, 2019
• Study Start: June 10, 2019
• Primary Completion: July 31, 2025
• Study Completion: September 30, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)