Nonsteroidal Antiinflammatory Drugs in Women With Postpartum Pre-eclampsia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01988298|
Recruitment Status : Completed
First Posted : November 20, 2013
Last Update Posted : July 28, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: Ibuprofen Drug: Acetaminophen||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Ibuprofen Versus Acetaminophen in Women With Severe Pre-eclampsia After Vaginal Delivery.|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
Experimental: Ibuprofen 400 mg each 8 hours for 2-3 days.
Ibuprofen 400 mg each 8 hours
Other Name: Ibuprofen in pre-eclampsia
Active Comparator: Acetaminophen
Acetaminophen 1 g oral each 6 hours, 2-3 days.
Other Name: Acetaminophen in pre-eclampsia
- level of postpartum hypertension [ Time Frame: levels of hypertension up to 4 days post paertum ]hypertension during the postpartum using acetaminophen or nonsteroidal antiinflammatory
- complications [ Time Frame: complications during the postpartum period (4 days) ]Renal failure, symptoms, bleeding
- convulsions [ Time Frame: maternal complicactions for 4 days postpartum ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01988298
|Paulino Vigil-De Gracia|
|Study Chair:||Paulino Vigil-De Gracia, MD||Complejo Hospitalario Caja de Seguro social|