NSAID Use in Postpartum Hypertensive Women

Women who have the diagnosis of hypertension (pre-pregnancy and pregnancy induced) and deliver an infant via vaginal delivery will be placed into two groups in the postpartum period. One group will receive Ibuprofen for pain control and the other group will be given Tylenol. Blood pressures during the postpartum period will then be collected and compared in order to see if NSAIDs use increases blood pressure.

Study Overview

• Status: Terminated
• Conditions: Hypertension
• Intervention / Treatment: Drug: Acetaminophen; Drug: NSAID

Detailed Description

The patients who have a vaginal delivery and have the diagnosis of hypertension in pregnancy will be randomized to either Ibuprofen use or acetaminophen use during the postpartum period. Standard blood pressure monitoring in the postpartum period will be followed to help determine if there is a significant rise in the women who use NSAIDS in the postpartum period versus those that use acetaminophen.

Groups will be divided into women with chronic hypertension, women with chronic hypertension with superimposed preeclampsia, women with preeclampsia without severe features, women with preeclampsia with severe features, women with gestational hypertension without severe range blood pressures, and women with gestational hypertension with severe range blood pressures.

Recruitment will last 36 months. Patients will be monitored during their postpartum stay (typical 2 days) with blood pressure measurements. An additional 12 months will be needed for data analysis and publication.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • St. Mary's Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 50 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• vaginal delivery
• diagnosis of chronic hypertension, chronic hypertension with superimposed preeclampsia
• preeclampsia without severe features
• preeclampsia with severe features gestational hypertension without severe range blood pressures
• gestational hypertension with severe range blood pressures
• singleton pregnancies

Exclusion Criteria:

• Cesarean Delivery
• no diagnosis of hypertensive disorder
• chronic or acute renal disease
• allergy to ibuprofen or acetaminophen
• lupus
• multiple order pregnancies (twins, triplets)
• Narcotic addiction/ in treatment for substance abuse/ current prescription drug user/ current use of illegal drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Acetaminophen; Patients will be monitored for change in blood pressure	Drug: Acetaminophen; Blood pressure will be monitored during postpartum stay (typical 2 days) and then again at 1 week and 6 weeks (standard practice of care) with blood pressure measurements; Other Names: Tylenol
Other: NSAID; Patients will be monitored during their postpartum stay (typical 2 days) and then again at 1 week and 6 weeks (standard practice of care) with blood pressure measurements	Drug: NSAID; Blood pressure will be monitored during postpartum stay (typical 2 days) and then again at 1 week and 6 weeks (standard practice of care) with blood pressure measurements; Other Names: Ibuprofen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Mean Systolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2.	To determine if NSAIDS in the postpartum period raise blood pressure in women with a hypertensive disorder. The mean increase and standard deviation of each group (acetaminophen and NSAID/Ibupforen) was calculated when compairing systolic blood pressures from the first postpartum day to the second postpartum day. Day 1 is the mean of systolic blood pressures from 0 hours to 23 hours after delivery, and Day 2 is the mean of systolic blood pressures from 24 hours to 47 hours after delivery.	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Mean Diastolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2.	To determine if NSAIDS in the postpartum period raise blood pressure in women with a hypertensive disorder. The mean increase and standard deviation of each group (acetaminophen and NSAID/Ibupforen) was calculated when compairing diastolic blood pressures from the first postpartum day to the second postpartum day. Day 1 is the mean of diastolic blood pressures from 0 hours to 23 hours after delivery, and Day 2 is the mean of diastolic blood pressures from 24 hours to 47 hours after delivery.	2 days

Collaborators and Investigators

• Sponsor: St. Louis University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2017
• Primary Completion (Actual): October 8, 2017
• Study Completion (Actual): October 8, 2017

Study Registration Dates

• First Submitted: September 12, 2016
• First Submitted That Met QC Criteria: September 12, 2016
• First Posted (Estimate): September 15, 2016

Study Record Updates

• Last Update Posted (Actual): October 31, 2018
• Last Update Submitted That Met QC Criteria: October 5, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ibuprofen
• Other Study ID Numbers: 26976

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No