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

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.

Inclusion Criteria:

- Antepartum women

- Diagnosis of Gestational Hypertension or Pre-eclampsia by blood pressure ≥140 systolic
or ≥90 diastolic, on at least 2 measurements ≥ 4 hours apart; with or without
proteinuria (urine protein-creatinine ratio ≥0.3 or 24 hour-urine protein ≥300 mg).

- Taking one or fewer oral medications for blood pressure control.

- Singleton gestation.

- English-speaking

Exclusion Criteria:

- Allergy to nonsteroidal anti-inflammatory drugs, aspirin, or acetaminophen

- More than 1 severe range blood pressure (≥160 systolic or ≥110 diastolic) prior to
enrollment.

- Neurologic symptoms attributed to hypertension (headache, visual changes) prior to
enrollment.

- Pulmonary edema.

- Elevated AST (>60 international units/L) or ALT (>70 international units/L) prior to
enrollment.

- Low platelet count (<100,000/microliter) prior to enrollment.

- Renal insufficiency (creatinine > 1.1 or double the baseline creatinine if known)
prior to enrollment.

- Chronic hypertension defined as hypertension pre-existing pregnancy or diagnosed prior
to 20-weeks' gestation.

- Moderate- or severe-persistent asthma.

- Therapeutic anticoagulation.

- Chronic opiate use during the pregnancy (opiate therapy given daily for > 2 weeks).

- Lactose intolerance or allergy due to placebo containing lactose.

- Cesarean delivery.

- Additional anesthesia at time of delivery (spinal anesthesia, sedation) that would
change routine pain management.