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OpenTrials
Completed

NCT Number: NCT01988298

Nonsteroidal Antiinflammatory Drugs in Women With Postpartum Pre-eclampsia

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.

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Key information

Age range

15 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Paulino Vigil-De Gracia

Panama City, Provincia de Panamá, Panama

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

sensitivities to ibuprofen cesarean delivery

Treatment and study plan

Ibuprofen

Drug

Ibuprofen 400 mg each 8 hours

Other names: Ibuprofen in pre-eclampsia

Acetaminophen

Drug

Control group

Other names: Acetaminophen in pre-eclampsia

Primary outcomes

  1. level of postpartum hypertension

    Time frame: levels of hypertension up to 4 days post paertum

    hypertension during the postpartum using acetaminophen or nonsteroidal antiinflammatory

Secondary outcomes

  1. complications

    Time frame: complications during the postpartum period (4 days)

    Renal failure, symptoms, bleeding

Other outcomes

  1. convulsions

    Time frame: maternal complicactions for 4 days postpartum

Sponsors and collaborators

Lead sponsor

Complejo Hospitalario Dr. Arnulfo Arias Madrid

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 20, 2013
Registry last updated
Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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