NSAID Use in Postpartum Hypertensive Women

Phase 4

Terminated

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.

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Acetaminophen	Acetaminophen	Patients will be monitored for change in blood pressure
NSAID	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

Primary Outcome Measures

Name	Time	Method
Change in the Mean Systolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2.	2 days	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.

Secondary Outcome Measures

Name	Time	Method
Change in the Mean Diastolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2.	2 days	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.