Clinical Trial: The Effect of Ibuprofen on Post-partum Blood Pressure in Women With Hypertensive Disorders of Pregnancy

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

Official Title: A Randomized-controlled Trial to Assess the Effect of Ibuprofen on Post-partum Blood Pressure in Women With Hypertensive Disorders of Pregnancy

Brief Summary: To assess the effect of routine doses of ibuprofen on post-partum blood pressure control in women with gestational hypertension (gHTN) or preeclampsia without severe features (preE).

Detailed Summary:

Non-steroidal anti-inflammatory drugs (NSAIDs) are frequently prescribed for post-partum analgesia. This use is supported by limited data on post-partum pain specifically; however, ibuprofen and other NSAIDs are superior to acetaminophen in ameliorating uterine pain and cramping in dysmenorrhea. The effect of NSAIDs on blood pressure (BP) in women post-partum is less well-known. In non-pregnant hypertensive patients NSAIDs are associated with increased BP over short courses of days to months, though effects of various NSAIDs differ. Pooled analyses suggest changes in mean BP of up to 3-6 mm Hg depending on the measurement method.There are case reports of hypertensive crises after NSAID administration post-partum in both normotensive and hypertensive women. A larger, recent retrospective cohort study found no difference in mean arterial pressure (MAP) or need for antihypertensive therapy in women with severe hypertensive disorders of pregnancy who were exposed to NSAIDs post-partum.

In light of the potential for worsening blood pressure in women with hypertensive disorders of pregnancy, the Task Force on Hypertension in Pregnancy of American College of Obstetricians and Gynecologists stated that "providers should be reminded of the contribution of nonsteroidal anti-inflammatory agents to increased BP." Additionally the task force recommends that NSAIDS "be replaced by other analgesics in women with hypertension that persists for more than 1 day postpartum". However, provider practices since the publication of these guidelines have varied.

Hypothesis: When compared to acetaminophen, ibuprofen does not increase post-partum systolic blood pressure (SBP) above baseline to a clinically relevant degree (≥10 mmHg) in women with gHTN and preE.

Aim 1: To ass
Sponsor: University of Michigan

Current Primary Outcome: Mean difference in systolic blood pressure (SBP) during 24 hours of exposure each to ibuprofen and acetaminophen [ Time Frame: Immediately post-partum, 24 hours post-partum, and 48 hours post-partum ]

To determine the difference in SBP from baseline (immediately post-partum) during 24 hours of drug exposure each to ibuprofen and acetaminophen. Baseline SBP will be calculated as the arithmetic mean of the initial 5 blood pressures recorded after admission for labor or induction of labor. Standard blood pressure monitoring per post-partum protocol: every 15 minutes for 1 hour, then every 30 min for 1 hour, then every 4-8 hours until discharge per the discretion of the treating team. The primary hypothesis is that of equivalence.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in pain score during immediate post-partum period [ Time Frame: 48 hours from initial study medication administration ]
    Prior to the first dose of pain medication, participants will take a brief, self-administered survey to assess abdominal and overall pain using a 0-10 scale. Two hours after the first dose of study drug, participants will repeat the self-administered survey to assess abdominal, perineal, and overall pain using a 0-10 scale. Pain scores as assessed by nursing during the 48 hours from initial study medication administration will also be abstracted from the participant's medical record.
  • Satisfaction with pain control during 24 hours of exposure each to ibuprofen and acetaminophen [ Time Frame: 24 hours and 48 hours after initial study medication administration ]
    A brief survey on satisfaction with pain control during the first 24 hours post-partum and the second 24 hours post-partum, as well as overall during post-partum stay will be administered prior to discharge using a 1-5 scale.


Original Secondary Outcome: Same as current

Information By: University of Michigan

Dates:
Date Received: August 26, 2016
Date Started: December 2016
Date Completion:
Last Updated: December 6, 2016
Last Verified: December 2016