Pre-eclampsia Clinical Trial
Official title:
A Randomized-controlled Trial to Assess the Effect of Ibuprofen on Post-partum Blood Pressure in Women With Hypertensive Disorders of Pregnancy
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).
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 assess the mean difference in SBP during 24 hours of exposure to ibuprofen and
acetaminophen.
Aim 2: To assess whether ibuprofen results in higher satisfaction with pain control in the
immediate post-partum period (48 hours) compared to acetaminophen.
Aim 3: To prospectively assess the need for post-partum anti-hypertensive therapy and
readmission for blood pressure control in women with gHTN and preE. The post-partum period is
defined as delivery through 6 weeks after delivery.
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