Nonsteroidal Antiinflammatory Drugs in Women With Postpartum Pre-eclampsia

Study Overview
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Brief Summary
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Hypertensive disorders of pregnancy are a major cause of maternal mortality and morbidity, especially in developing countries. Postpartum hypertension can be related to persistence of gestational hypertension, preeclampsia, or preexisting chronic hypertension, or it could develop de novo secondary to other causes. The available data in the medical literature have primarily focused on antenatal and peripartum management. There are few data regarding the evaluation in women who are diagnosis with postpartum hypertension. Some medications that cause vasoconstriction are often used for pain relief, in women having perineal lacerations, episiotomy, or cesarean delivery. Such women usually require large doses of nonsteroidal antiinflammatory drugs that are associated with vasoconstriction and sodium and water retention, this drugs can result in severe hypertension. The purpose of this study is to evaluate maternal postpartum hypertension in women with severe preeclampsia treated with nonsteroidal antiinflammatory drugs or acetaminophen.

Detailed Description
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Our objective is evaluate Ibuprofen or acetaminophen used for pain during the postpartum period in women with severe pre-eclampsia. We include only women with vaginal delivery.

Official Title
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Ibuprofen Versus Acetaminophen in Women With Severe Pre-eclampsia After Vaginal Delivery.

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Ibuprofen
* Drug: Acetaminophen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Vaginal delivery severe pre-eclampsia severe gestational hypertension aggregate pre-eclampsia Exclusion Criteria: sensitivities to ibuprofen cesarean delivery

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibuprofen<br>Experimental: Ibuprofen 400 mg each 8 hours for 2-3 days. | Drug: Ibuprofen<br>* Ibuprofen 400 mg each 8 hours<br>* Other names: Ibuprofen in pre-eclampsia;|
| Active Comparator: Acetaminophen<br>Acetaminophen 1 g oral each 6 hours, 2-3 days. | Drug: Acetaminophen<br>* Control group<br>* Other names: Acetaminophen in pre-eclampsia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of postpartum hypertension | hypertension during the postpartum using acetaminophen or nonsteroidal antiinflammatory | levels of hypertension up to 4 days post paertum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications | Renal failure, symptoms, bleeding | complications during the postpartum period (4 days) |