Nonsteroidal Antiinflammatory Drugs in Women With Postpartum Pre-eclampsia

NCT01988298 | Completed Phase 2 DMC

• 1 other identifier: Complejoh 02
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• level of postpartum hypertension

  hypertension during the postpartum using acetaminophen or nonsteroidal antiinflammatory

  levels of hypertension up to 4 days post paertum

Secondary Outcomes (1)

• complications

  complications during the postpartum period (4 days)

Other Outcomes (1)

• convulsions

  maternal complicactions for 4 days postpartum

Study Arms (2)

Ibuprofen

EXPERIMENTAL

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

Drug: Ibuprofen

Acetaminophen

ACTIVE COMPARATOR

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

Drug: Acetaminophen

Interventions

Ibuprofen DRUG

Ibuprofen 400 mg each 8 hours

Also known as: Ibuprofen in pre-eclampsia

Ibuprofen

Acetaminophen DRUG

Control group

Also known as: Acetaminophen in pre-eclampsia

Acetaminophen

Eligibility Criteria

• Age: 15 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• sensitivities to ibuprofen cesarean delivery

Sponsors & Collaborators

• Complejo Hospitalario Dr. Arnulfo Arias Madrid: lead

Study Sites (1)

Paulino Vigil-De Gracia

Panama City, Provincia de Panamá, Panama

Location

MeSH Terms

Conditions

Hypertension

Interventions

Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Paulino Vigil-De Gracia, MD

  Complejo Hospitalario Caja de Seguro social

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gynecology and obstetric, investigator and teaching proffesor

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: November 20, 2013
• Study Start: October 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: July 28, 2015

Record last verified: 2015-07

Locations

PA (1)