NSAID Use in Postpartum Hypertensive Women

Hypertension Clinical Trial

Official title:

NSAID Use in Postpartum Hypertensive Women

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02902172
• Other study ID #: 26976
• Status: Terminated
• Phase: Phase 4
• Start date: March 15, 2017
• Est. completion date: October 8, 2017

Study information

• Verified date: October 2018
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: October 8, 2017
• Est. primary completion date: October 8, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

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
• 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

Locations

Country	Name	City	State
United States	St. Mary's Health Center	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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