The Effect of Ibuprofen on Post-partum Blood Pressure in Women With Hypertensive Disorders of Pregnancy
Condition: Hypertension, Pregnancy-Induced; Pre-eclampsia
MeSH terms: Toxemia; Eclampsia; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Hypertension
Study type: Interventional
Phase: Phase 4

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 description: 
      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.
    

Intervention name(s): Ibuprofen; Acetaminophen
Intervention type(s): Drug; Drug
Intervention description(s): At the time of delivery, eligibility will be reviewed. If the participant remains eligible, she will be randomized by the study pharmacy to begin post-partum analgesic therapy with ibuprofen followed by acetaminophen.; At the time of delivery, eligibility will be reviewed. If the participant remains eligible, she will be randomized by the study pharmacy to begin post-partum analgesic therapy with acetaminophen followed by ibuprofen.
Other intervention name(s): Advil; Motrin; Tylenol
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ibuprofen; acetaminophen; blood pressure; post-partum; pain control; pre-eclampsia; gestational hypertension