Nonsteroidal Antiinflammatory Drugs in Women With Postpartum Pre-eclampsia

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Ibuprofen; Drug: Acetaminophen

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.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Panama
  • Panamá, Panama
    • Paulino Vigil-De Gracia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 44 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

sensitivities to ibuprofen cesarean delivery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Ibuprofen in pre-eclampsia
ACTIVE_COMPARATOR: Acetaminophen; Acetaminophen 1 g oral each 6 hours, 2-3 days.	Drug: Acetaminophen; Control group; Other Names: Acetaminophen in pre-eclampsia

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Time Frame
convulsions	maternal complicactions for 4 days postpartum

Collaborators and Investigators

• Sponsor: Complejo Hospitalario Dr. Arnulfo Arias Madrid
• Investigators: Study Chair: Paulino Vigil-De Gracia, MD, Complejo Hospitalario Caja de Seguro Social

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ACTUAL): February 1, 2015
• Study Completion (ACTUAL): February 1, 2015

Study Registration Dates

• First Submitted: October 31, 2013
• First Submitted That Met QC Criteria: November 19, 2013
• First Posted (ESTIMATE): November 20, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): July 28, 2015
• Last Update Submitted That Met QC Criteria: July 27, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ibuprofen
• Other Study ID Numbers: Complejoh 02