NCT02902172

NSAID Use in Postpartum Hypertensive Women

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: St. Louis University · Academic / Other
• Sex: Female
• Age: 14 Years – 50 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2017-03-15
• Primary completion: 2017-10-08
• Completion: 2017-10-08
• First posted: 2016-09-15
• Last updated: 2018-10-31
• Results posted: 2018-10-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study