Clinical Trial: Hypertension In Postpartum Preeclampsia Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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).


Sponsor: MemorialCare Health System

Current Primary Outcome:

  • Average Mean Arterial Blood Pressure [ Time Frame: Averaged from all blood pressures measured through study completion, an average of 3 days ]
    Primary outcome for HDP-Mild Study Group
  • Antihypertensive Treatment During Inpatient Postpartum Hospitalization [ Time Frame: Through study completion, an average of 3 days ]
    Primary outcome for HDP- Severe Study Group


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Wong-Baker Facial Grimace Pain Scale Scores During Inpatient Postpartum Hospital Stay [ Time Frame: Through study completion, an average of 3 days ]
  • Outpatient Blood Pressure Measurement [ Time Frame: 3 days after discharge from the hospital ]
    Outpatient postpartum blood pressure measurement within 3 days after discharge
  • Patient Satisfaction/Side Effects [ Time Frame: Through study completion, an average of 3 days ]
  • Length of Hospital Stay [ Time Frame: Through study completion, an average of 3 days ]


Original Secondary Outcome: Same as current

Information By: MemorialCare Health System

Dates:
Date Received: January 2, 2017
Date Started: January 2017
Date Completion: June 2018
Last Updated: January 13, 2017
Last Verified: January 2017