NSAID Use in Postpartum Hypertensive Women

NCT02902172 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 26976
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in the Mean Diastolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2.

  2 days

Study Arms (2)

Acetaminophen

OTHER

Patients will be monitored for change in blood pressure

Drug: Acetaminophen

NSAID

OTHER

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

Interventions

Acetaminophen DRUG

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

Also known as: Tylenol

Acetaminophen

NSAID DRUG

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

Also known as: Ibuprofen

NSAID

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

St. Mary's Health Center

St Louis, Missouri, 63117, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal; Ibuprofen

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Results Point of Contact

• Title: Dr. Jennifer Goldkamp
• Organization: St. Louis University

jen.goldkamp@health.slu.edu

3149772200

Study Officials

• Jennifer Goldkamp, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: September 15, 2016
• Study Start: March 15, 2017
• Primary Completion: October 8, 2017
• Study Completion: October 8, 2017
• Last Updated: October 31, 2018
• Results First Posted: October 31, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)