Nonsteroidal Antiinflammatory Drugs in Women With Postpartum Pre-eclampsia

Phase 2

Completed

• Conditions: Hypertension
• Interventions: Drug: Acetaminophen; Drug: Ibuprofen

• Registration Number: NCT01988298
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-31
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-20
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 114

Inclusion Criteria

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

Exclusion Criteria

sensitivities to ibuprofen cesarean delivery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acetaminophen	Acetaminophen	Acetaminophen 1 g oral each 6 hours, 2-3 days.
Ibuprofen	Ibuprofen	Experimental: Ibuprofen 400 mg each 8 hours for 2-3 days.

Primary Outcome Measures

Name	Time	Method
level of postpartum hypertension	levels of hypertension up to 4 days post paertum	hypertension during the postpartum using acetaminophen or nonsteroidal antiinflammatory

Secondary Outcome Measures

Name	Time	Method
complications	complications during the postpartum period (4 days)	Renal failure, symptoms, bleeding

Trial Locations

Locations (1)

Paulino Vigil-De Gracia; 🇵🇦 Panamá, Panama