A Phase 2/3 interventional study of Ibuprofen and Acetaminophen in Hypertension, sponsored by Complejo Hospitalario Dr. Arnulfo Arias Madrid. Completed at 1 site in Panama. Open to female participants aged 15 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-28.
Sponsored by Complejo Hospitalario Dr. Arnulfo Arias Madrid · Phase 2/3, Interventional, and Supportive care
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.
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's enrollment of 114 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →Complejo Hospitalario Dr. Arnulfo Arias Madrid is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Vaginal delivery severe pre-eclampsia severe gestational hypertension aggregate pre-eclampsia
Exclusion Criteria:
sensitivities to ibuprofen cesarean delivery
Experimental: Ibuprofen 400 mg each 8 hours for 2-3 days.
Drug: Ibuprofen
Acetaminophen 1 g oral each 6 hours, 2-3 days.
Drug: Acetaminophen
Ibuprofen 400 mg each 8 hours
Also known as: Ibuprofen in pre-eclampsia
Control group
Also known as: Acetaminophen in pre-eclampsia
level of postpartum hypertension
hypertension during the postpartum using acetaminophen or nonsteroidal antiinflammatory
Time frame: levels of hypertension up to 4 days post paertum
complications
Renal failure, symptoms, bleeding
Time frame: complications during the postpartum period (4 days)
convulsions
Time frame: maternal complicactions for 4 days postpartum
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ibuprofen
Complejo Hospitalario Dr. Arnulfo Arias Madrid