NSAID Use in Postpartum Hypertensive Women

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-15

Study Completion Date

2017-10-08

Brief Summary

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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.

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Detailed Description

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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

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Acetaminophen

Patients will be monitored for change in blood pressure

Group Type OTHER

Acetaminophen

Intervention Type 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

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

Group Type OTHER

NSAID

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Tylenol Ibuprofen

Eligibility Criteria

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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

Minimum Eligible Age

14 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes