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Trial record 1 of 9 for:    severe preeclampsia AND eclampsia | Panama
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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. Identifier: NCT01988298
Recruitment Status : Completed
First Posted : November 20, 2013
Last Update Posted : July 28, 2015
Information provided by (Responsible Party):
Paulino Vigil-De Gracia, Complejo Hospitalario Dr. Arnulfo Arias Madrid

Brief Summary:

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

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
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

Arm Intervention/treatment
Experimental: Ibuprofen
Experimental: Ibuprofen 400 mg each 8 hours for 2-3 days.
Drug: Ibuprofen
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.
Drug: Acetaminophen
Control group
Other Name: Acetaminophen in pre-eclampsia

Primary Outcome Measures :
  1. level of postpartum hypertension [ Time Frame: levels of hypertension up to 4 days post paertum ]
    hypertension during the postpartum using acetaminophen or nonsteroidal antiinflammatory

Secondary Outcome Measures :
  1. complications [ Time Frame: complications during the postpartum period (4 days) ]
    Renal failure, symptoms, bleeding

Other Outcome Measures:
  1. convulsions [ Time Frame: maternal complicactions for 4 days postpartum ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 44 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Vaginal delivery severe pre-eclampsia severe gestational hypertension aggregate pre-eclampsia

Exclusion Criteria:

sensitivities to ibuprofen cesarean delivery

Information from the National Library of Medicine

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 identifier (NCT number): NCT01988298

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Paulino Vigil-De Gracia
Panamá, Panama
Sponsors and Collaborators
Complejo Hospitalario Dr. Arnulfo Arias Madrid
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Study Chair: Paulino Vigil-De Gracia, MD Complejo Hospitalario Caja de Seguro social
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Responsible Party: Paulino Vigil-De Gracia, Gynecology and obstetric, investigator and teaching proffesor, Complejo Hospitalario Dr. Arnulfo Arias Madrid Identifier: NCT01988298    
Other Study ID Numbers: Complejoh 02
First Posted: November 20, 2013    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Hypertension, Pregnancy-Induced
Pregnancy Complications
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action