The Effect of Ibuprofen on Post-partum Blood Pressure in Women With Hypertensive Disorders of Pregnancy

NCT02891174 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HUM00117154
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the effect of routine doses of ibuprofen on post-partum blood pressure control in women with gestational hypertension (gHTN) or preeclampsia without severe features (preE).

Conditions

Hypertension, Pregnancy-Induced; Pre-eclampsia

Keywords

ibuprofen; acetaminophen; blood pressure; post-partum; pain control; pre-eclampsia; gestational hypertension

Outcome Measures

Primary Outcomes (1)

• Difference in Systolic Blood Pressure (SBP)

  The adjusted mean difference in systolic blood pressure after 24 hours of exposure each to ibuprofen and acetaminophen.

  24 hours following intervention

Secondary Outcomes (3)

• Change in Self-reported Pain Score 2 Hours After First Intervention

  At the time of first dose of study drug and 2 hours after

• Mean Pain Score by Nursing Assessment

  0-24 hours and 24-48 hours after initial study medication administration

• Satisfaction With Pain Control During 24 Hours of Exposure Each to Ibuprofen and Acetaminophen

  24 hours and 48 hours after initial study medication administration

Study Arms (2)

Ibuprofen followed by acetaminophen

ACTIVE COMPARATOR

Ibuprofen administered immediately post-partum, 600 mg (3 x 200 mg tablets) every 6 hours for 24 hours followed by acetaminophen, 650 mg (2 x 325 mg tablets) every 6 hours for 24 hours.

Drug: Ibuprofen; Drug: Acetaminophen

Acetaminophen followed by ibuprofen

ACTIVE COMPARATOR

Acetaminophen administered immediately post-partum, 650 mg (2 x 325 mg tablets) every 6 hours for 24 hours followed by ibuprofen, 600 mg (3 x 200 mg tablets) every 6 hours for 24 hours.

Drug: Ibuprofen; Drug: Acetaminophen

Interventions

Ibuprofen DRUG

At the time of delivery, eligibility will be reviewed. If the participant remains eligible, she will be randomized by the study pharmacy to begin post-partum analgesic therapy with ibuprofen followed by acetaminophen.

Also known as: Advil, Motrin

Acetaminophen followed by ibuprofen; Ibuprofen followed by acetaminophen

Acetaminophen DRUG

At the time of delivery, eligibility will be reviewed. If the participant remains eligible, she will be randomized by the study pharmacy to begin post-partum analgesic therapy with acetaminophen followed by ibuprofen.

Also known as: Tylenol

Acetaminophen followed by ibuprofen; Ibuprofen followed by acetaminophen

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Antepartum women
• Diagnosis of Gestational Hypertension or Pre-eclampsia by blood pressure ≥140 systolic or ≥90 diastolic, on at least 2 measurements ≥ 4 hours apart; with or without proteinuria (urine protein-creatinine ratio ≥0.3 or 24 hour-urine protein ≥300 mg).
• Taking one or fewer oral medications for blood pressure control.
• Singleton gestation.
• English-speaking

You may not qualify if:

• Allergy to nonsteroidal anti-inflammatory drugs, aspirin, or acetaminophen
• More than 1 severe range blood pressure (≥160 systolic or ≥110 diastolic) prior to enrollment.
• Neurologic symptoms attributed to hypertension (headache, visual changes) prior to enrollment.
• Pulmonary edema.
• Elevated AST (\>60 international units/L) or ALT (\>70 international units/L) prior to enrollment.
• Low platelet count (\<100,000/microliter) prior to enrollment.
• Renal insufficiency (creatinine \> 1.1 or double the baseline creatinine if known) prior to enrollment.
• Chronic hypertension defined as hypertension pre-existing pregnancy or diagnosed prior to 20-weeks' gestation.
• Moderate- or severe-persistent asthma.
• Therapeutic anticoagulation.
• Chronic opiate use during the pregnancy (opiate therapy given daily for \> 2 weeks).
• Lactose intolerance or allergy due to placebo containing lactose.
• Cesarean delivery.
• Additional anesthesia at time of delivery (spinal anesthesia, sedation) that would change routine pain management.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Pre-Eclampsia; Agnosia

Interventions

Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Elizabeth Langen
• Organization: University of Michigan

elangen@med.umich.edu

734-764-3406

Study Officials

• Jourdan Triebwasser, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Elizabeth Langen, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Alexander Tsodikov, PhD

  University of Michigan

  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: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: September 7, 2016
• Study Start: December 1, 2016
• Primary Completion: March 31, 2018
• Study Completion: June 20, 2018
• Last Updated: May 23, 2019
• Results First Posted: May 23, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)