Effect of Acetaminophen on Postpartum Blood Pressure Control in Preeclampsia With Severe Features

NCT02911701 | Completed Phase 4 Results DMC

• 1 other identifier: 16-147
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

NSAIDs, specifically cyclo-oxygenase (COX) inhibitors, are known to increase blood pressure over time in non-pregnant adults, but the effect of COX-inhibitors on blood pressure in the setting of preeclampsia have not been well studied. This study aims to assess the effect of avoiding COX-inhibitors on postpartum blood pressure control among women diagnosed with preeclampsia with severe features. Eligible women will be randomized to receive either acetaminophen or ibuprofen for postpartum pain control. Both agents are first line therapies for pain control although ibuprofen has better pain control than acetaminophen. The primary outcome will be duration of postpartum severe-range hypertension.

Conditions

Pre-Eclampsia; HELLP Syndrome; Eclampsia

Outcome Measures

Primary Outcomes (1)

• Duration of Severe-range Hypertension After Delivery

  length of time from delivery to the last severe range blood pressure (160/110mm Hg) measured

  duration of postpartum hospitalization (approximately 3-7 days)

Secondary Outcomes (18)

• Length of Hospitalization

  duration of postpartum hospitalization (approximately 3-7 days)

• Mean Arterial Pressure Over the Entire Postpartum Hospitalization

  duration of postpartum hospitalization (approximately 3-7 days)

• Mean Arterial Pressure, Stratified by Postpartum Day 1, 2, 3, Etc.

  duration of postpartum hospitalization (approximately 3-7 days)

• Mean Total Number of Severe Range Blood Pressure Measurements in Each Study Arm.

  duration of postpartum hospitalization (approximately 3-7 days)

• Proportion of Study Participants in Each Study Arm Who Have Any Postpartum Severe Range BPs

  duration of postpartum hospitalization (approximately 3-7 days)

Study Arms (2)

Acetaminophen

EXPERIMENTAL

Study participants randomized to the acetaminophen group will receive 650mg of acetaminophen orally every 6 hours during their postpartum hospital stay.

Drug: Acetaminophen

Ibuprofen

ACTIVE COMPARATOR

Study participants randomized to the ibuprofen group will receive 600mg of ibuprofen orally every 6 hours during their postpartum hospital stay.

Drug: Ibuprofen

Interventions

Acetaminophen DRUG

Also known as: Tylenol

Acetaminophen

Ibuprofen DRUG

Also known as: Motrin

Ibuprofen

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ability to give informed consent
• diagnosis of a "severe" hypertensive disorder of pregnancy:
• preeclampsia with severe features
• chronic hypertension with superimposed preeclampsia with severe features
• HELLP syndrome: hemolysis, elevated liver function tests, low platelets
• eclampsia
• not yet delivered or less than 6 hours after delivery

You may not qualify if:

• current incarceration
• serum creatinine \> 1.0 mg/dL or suspicion of acute kidney injury
• AST (aspartate aminotransferase) \>200 unit/L
• ALT (alanine aminotransferase) \> 200 unit/L
• known allergy or sensitivity to NSAIDs or acetaminophen
• delivery \> 6 hours prior to enrollment
• chronic kidney disease
• chronic liver disease
• prior liver transplant
• chronic infectious hepatitis
• gastritis
• gastro-esophageal reflux disease (GERD)
• peptic ulcer disease
• bleeding disorder
• provider feels that participation is not in the best interest of the patient

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, United States

Location

MeSH Terms

Conditions

Pre-Eclampsia; HELLP Syndrome; Eclampsia

Interventions

Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Results Point of Contact

• Title: Dr. Nathan Blue
• Organization: University of New Mexico, Division of Maternal-Fetal Medicine

nblue1297@gmail.com

505-272-6309

Study Officials

• Luis Izquierdo, MD, MBA

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinician Education

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 22, 2016
• Study Start: September 1, 2016
• Primary Completion: November 7, 2017
• Study Completion: January 10, 2018
• Last Updated: July 27, 2023
• Results First Posted: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)