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
Intervention: Ibuprofen; Acetaminophen
Intervention description: 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.
Intervention MeSH terms: Acetaminophen; Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 74.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: ibuprofen; acetaminophen; blood pressure; post-partum; pain control; pre-eclampsia; gestational hypertension

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).
    

Eligibility criteria:

        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.