NSAID Use in Postpartum Hypertensive Women

Saint Louis University (SLU)

Status and phase: Terminated; Phase 4

Conditions: Hypertension

Treatments: Drug: Acetaminophen; Drug: NSAID

Study type: Interventional

Funder types: Other

Identifiers

NCT02902172

26976

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: Female

Ages: 14 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 2 patient groups

Acetaminophen

Other group

Description:

Patients will be monitored for change in blood pressure

Treatment:

Drug: Acetaminophen

NSAID

Other group

Description:

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

Treatment:

Drug: NSAID