Nonsteroidal Antiinflammatory Drugs in Women With Postpartum Pre-eclampsia

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01988298
• Other study ID #: Complejoh 02
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 31, 2013
• Last updated: July 27, 2015
• Start date: October 2013
• Est. completion date: February 2015

Study information

• Verified date: July 2015
• Source: Complejo Hospitalario Dr. Arnulfo Arias Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Panama: Commemorative Institute GORGAS of Studies of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 44 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

sensitivities to ibuprofen cesarean delivery

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hypertension
• Pre-Eclampsia

Intervention

Drug:
• Ibuprofen
Ibuprofen 400 mg each 8 hours
• Acetaminophen
Control group

Locations

Country	Name	City	State
Panama	Paulino Vigil-De Gracia	Panamá

Sponsors (1)

Lead Sponsor	Collaborator
Complejo Hospitalario Dr. Arnulfo Arias Madrid

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	convulsions		maternal complicactions for 4 days postpartum	Yes
Primary	level of postpartum hypertension	hypertension during the postpartum using acetaminophen or nonsteroidal antiinflammatory	levels of hypertension up to 4 days post paertum	Yes
Secondary	complications	Renal failure, symptoms, bleeding	complications during the postpartum period (4 days)	Yes