Nonsteroidal Antiinflammatory Drugs in Women With Postpartum Pre-eclampsia

NCT ID: NCT01988298

Last Updated: 2015-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-02-28

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.

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Ibuprofen

Experimental: Ibuprofen 400 mg each 8 hours for 2-3 days.

Group Type: EXPERIMENTAL

Ibuprofen

Intervention Type: DRUG

Ibuprofen 400 mg each 8 hours

Acetaminophen

Acetaminophen 1 g oral each 6 hours, 2-3 days.

Group Type: ACTIVE_COMPARATOR

Acetaminophen

Intervention Type: DRUG

Control group

Interventions

Ibuprofen

Ibuprofen 400 mg each 8 hours

Intervention Type: DRUG

Acetaminophen

Control group

Intervention Type: DRUG

Other Intervention Names

Ibuprofen in pre-eclampsia; Acetaminophen in pre-eclampsia

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

sensitivities to ibuprofen cesarean delivery

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Complejo Hospitalario Dr. Arnulfo Arias Madrid

OTHER

Sponsor Role: lead

Responsible Party

Paulino Vigil-De Gracia

Gynecology and obstetric, investigator and teaching proffesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paulino Vigil-De Gracia, MD

Role: STUDY_CHAIR

Complejo Hospitalario Caja de Seguro social

Locations

Paulino Vigil-De Gracia

Panama City, Provincia de Panamá, Panama

Countries

Panama

Other Identifiers

Complejoh 02

Identifier Type: -

Identifier Source: org_study_id