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Nonsteroidal Antiinflammatory Drugs in Women With Postpartum Pre-eclampsia

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01988298
Enrollment
114
Registered
2013-11-20
Start date
2013-10-31
Completion date
2015-02-28
Last updated
2015-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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.

Interventions

DRUGIbuprofen

Ibuprofen 400 mg each 8 hours

DRUGAcetaminophen

Control group

Sponsors

Complejo Hospitalario Dr. Arnulfo Arias Madrid
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 44 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

sensitivities to ibuprofen cesarean delivery

Design outcomes

Primary

MeasureTime frameDescription
level of postpartum hypertensionlevels of hypertension up to 4 days post paertumhypertension during the postpartum using acetaminophen or nonsteroidal antiinflammatory

Secondary

MeasureTime frameDescription
complicationscomplications during the postpartum period (4 days)Renal failure, symptoms, bleeding

Other

MeasureTime frame
convulsionsmaternal complicactions for 4 days postpartum

Countries

Panama

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026