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

NCT ID: NCT02911701

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-01-10

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.

Detailed Description

The proposed study is a randomized, controlled, double-masked trial comparing the effect of postpartum acetaminophen and ibuprofen on blood pressure among women with preeclampsia. Study participants will be randomized to receive either acetaminophen or ibuprofen for mild postpartum pain control. Study participants, study personnel and providers will be blinded to randomization status of study participants.

Potential study participants will be enrolled when they are diagnosed with a severe hypertensive disorder of pregnancy. This will usually occur prior to delivery, but may occur up to 6 hours after delivery. Patients diagnosed with preeclampsia without severe features will also be approached and enrolled at the time of diagnosis in anticipation for possible progression to preeclampsia with severe features. Once enrolled, study participants will not be randomized until delivery, at which time they will be randomized to receive either acetaminophen or ibuprofen for mild postpartum pain. Both groups will have available oxycodone for moderate to severe pain, per our routine. Study group allocation will only be known by the investigational pharmacy. The ibuprofen and acetaminophen will be made to appear identical to each other and will be unmarked through encapsulation. Block randomization will be used to ensure equal allocation to the two study arms.

For the duration of study participation, study participants will undergo postpartum monitoring with vital sign measurements (including blood pressure) every 4 hours, pain assessment with each administration of study medication, as well as daily evaluation of laboratory studies until they have normalized to the satisfaction of their provider. Study participants will receive the study drug every 6 hours from the time of delivery until hospital discharge, unless they refuse. Study participation will be complete upon hospital discharge. Study participants will be contacted by a study team member 6 weeks after delivery to ask about any additional complications or symptoms requiring visits to the emergency department or hospital readmission. Descriptive factors and clinical outcomes will be extracted from the medical record and de-identified by study personnel during each day of study participation.

Conditions

Pre-Eclampsia; HELLP Syndrome; Eclampsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Acetaminophen

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

Group Type: EXPERIMENTAL

Acetaminophen

Intervention Type: DRUG

Ibuprofen

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

Group Type: ACTIVE_COMPARATOR

Ibuprofen

Intervention Type: DRUG

Interventions

Acetaminophen

Intervention Type: DRUG

Ibuprofen

Intervention Type: DRUG

Other Intervention Names

Tylenol; Motrin

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

Luis Izquierdo

Associate Professor of Clinician Education

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luis Izquierdo, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

16-147

Identifier Type: -

Identifier Source: org_study_id