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Nonsteroidal Antiinflammatory Drugs in Women With Postpartum Pre-eclampsia

C

Complejo Hospitalario Dr. Arnulfo Arias Madrid

Status and phase

Completed
Phase 3
Phase 2

Conditions

Hypertension

Treatments

Drug: Acetaminophen
Drug: Ibuprofen

Study type

Interventional

Funder types

Other

Identifiers

NCT01988298
Complejoh 02

Details and patient eligibility

About

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.

Full 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.

Enrollment

114 patients

Sex

Female

Ages

15 to 44 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

sensitivities to ibuprofen cesarean delivery

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

114 participants in 2 patient groups

Ibuprofen
Experimental group
Description:
Experimental: Ibuprofen 400 mg each 8 hours for 2-3 days.
Treatment:
Drug: Ibuprofen
Acetaminophen
Active Comparator group
Description:
Acetaminophen 1 g oral each 6 hours, 2-3 days.
Treatment:
Drug: Acetaminophen

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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