Summary

for females ages 18 years and up (full criteria)
at UC Irvine
study started
estimated completion:

Description

Summary

This study aims to evaluate whether NSAIDs (Non-steroidal antiinflammatory drugs) administered during the postpartum period influence blood pressure in women with hypertensive disorders of pregnancy. The study design is a prospective double blinded randomized control trial with participants randomized to receive postpartum analgesic regimens with and without NSAIDs.

Official Title

A Randomized Controlled Trial on the Effects of NSAIDs on Postpartum Blood Pressure in Patients Hypertensive Disorders of Pregnancy

Details

Non-steroidal antiinflammatory drugs (NSAIDs) are effective agents for the management of pain in the postpartum period. The addition of NSAIDs to post-cesarean analgesic regimen has been shown to improve post-cesarean pain and reduce opioid requirements. However, concern has been raised over use of NSAIDs in hypertensive pregnant patients, as recent evidence suggests the potential for increased blood pressure in patients with chronic hypertensive disorders receiving these agents. Notably, these studies were conducted on patients with longstanding chronic hypertension, which included males and non-pregnant females, and it is therefore unclear whether this recommendation is appropriate for patients with transient hypertensive disorders of pregnancy.

This protocol describes a randomized trial to evaluate whether NSAIDs influence blood pressure parameters in patients with hypertensive disorders of pregnancy. Patients with severe hypertensive disorders of pregnancy (Severe HDP) will be studied separately from women with mild hypertensive disorders of pregnancy (Mild HDP).

Keywords

Hypertension, Pregnancy-Induced Postpartum Hypertension Acetaminophen Ibuprofen Severe HDP- NSAID Mild HDP- NSAID

Eligibility

You can join if…

Open to females ages 18 years and up

  • Delivery occurred at equal to or greater than 24 0/7 weeks gestational age
  • Patient receiving care with the Women's Perinatal Group (Maternal Fetal Medicine practice) or Obstetric Clinic resident services
  • Diagnosis of a hypertensive disorder of pregnancy (HDP), including the following:
  • Gestational hypertension
  • Preeclampsia without severe features
  • Preeclampsia with severe features
  • Hemolysis, Elevated Liver Enzymes, Low Platelet (HELLP) Syndrome
  • Eclampsia

You CAN'T join if...

  • Diagnosis of chronic hypertension or documentation of elevated blood pressures before 20 weeks gestational age.
  • Severe hypertension: Patients with at least one severe blood pressure measurement(systolic >160mmHg or diastolic >105mmHg) prior to randomization
  • Renal dysfunction (Serum creatinine measurement >1.3mg/dL during the current pregnancy)
  • Low platelet count (recorded measurement <50,000 during hospital admission)
  • Significant liver dysfunction (AST or ALT >500)
  • Known sensitivities to ibuprofen or acetaminophen
  • Use of therapeutic doses of anticoagulation (low dose anticoagulation used for routine prophylaxis of venous thromboembolism is acceptable)
  • Postpartum hemorrhage requiring transfusion

Location

  • Miller Children and Women Hospital Long Beach accepting new patients
    Long Beach California 90806 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
MemorialCare Health System
ID
NCT03011567
Study Type
Interventional
Last Updated