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Nonsteroidal Antiinflammatory Drugs in Women With Postpartum Pre-eclampsia

Primary Purpose

Hypertension

Status
Completed
Phase
Phase 2
Locations
Panama
Study Type
Interventional
Intervention
Ibuprofen
Acetaminophen
Sponsored by
Complejo Hospitalario Dr. Arnulfo Arias Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypertension

Eligibility Criteria

15 Years - 44 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

sensitivities to ibuprofen cesarean delivery

Sites / Locations

  • Paulino Vigil-De Gracia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ibuprofen

Acetaminophen

Arm Description

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

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

Outcomes

Primary Outcome Measures

level of postpartum hypertension
hypertension during the postpartum using acetaminophen or nonsteroidal antiinflammatory

Secondary Outcome Measures

complications
Renal failure, symptoms, bleeding

Full Information

First Posted
October 31, 2013
Last Updated
July 27, 2015
Sponsor
Complejo Hospitalario Dr. Arnulfo Arias Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT01988298
Brief Title
Nonsteroidal Antiinflammatory Drugs in Women With Postpartum Pre-eclampsia
Official Title
Ibuprofen Versus Acetaminophen in Women With Severe Pre-eclampsia After Vaginal Delivery.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Complejo Hospitalario Dr. Arnulfo Arias Madrid

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ibuprofen
Arm Type
Experimental
Arm Description
Experimental: Ibuprofen 400 mg each 8 hours for 2-3 days.
Arm Title
Acetaminophen
Arm Type
Active Comparator
Arm Description
Acetaminophen 1 g oral each 6 hours, 2-3 days.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
Ibuprofen in pre-eclampsia
Intervention Description
Ibuprofen 400 mg each 8 hours
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Acetaminophen in pre-eclampsia
Intervention Description
Control group
Primary Outcome Measure Information:
Title
level of postpartum hypertension
Description
hypertension during the postpartum using acetaminophen or nonsteroidal antiinflammatory
Time Frame
levels of hypertension up to 4 days post paertum
Secondary Outcome Measure Information:
Title
complications
Description
Renal failure, symptoms, bleeding
Time Frame
complications during the postpartum period (4 days)
Other Pre-specified Outcome Measures:
Title
convulsions
Time Frame
maternal complicactions for 4 days postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Vaginal delivery severe pre-eclampsia severe gestational hypertension aggregate pre-eclampsia Exclusion Criteria: sensitivities to ibuprofen cesarean delivery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulino Vigil-De Gracia, MD
Organizational Affiliation
Complejo Hospitalario Caja de Seguro social
Official's Role
Study Chair
Facility Information:
Facility Name
Paulino Vigil-De Gracia
City
Panamá
Country
Panama

12. IPD Sharing Statement

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Nonsteroidal Antiinflammatory Drugs in Women With Postpartum Pre-eclampsia

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