A randomized non-inferiority trial of women with preeclampsia with severe features to determine if the addition of nonsteroidal anti-inflammatory drugs is inferior or non-inferior to standard analgesic bundles in their impact on postpartum hypertension.
Recently published clinical guidelines for the care of women with hypertensive disorders recommended that nonsteroidal anti-inflammatory drugs (NSAIDs) should be withheld from patients with hypertension that persists for more than one day postpartum (1). This recommendation is based in data from the general medicine literature, which suggests a role of NSAIDs in precipitating hypertension in non-pregnant adults (2,3). It may also draw from previously published case reports of post-partum hypertension that were thought to be NSAID induced (4). There has been a paucity of data from the obstetric literature to support or rebuff this recommendation. As the opioid crisis worsens in the United States, additional attention and resources have focused on limiting the use of narcotic medications. The effective employment of non-opioid analgesics has been shown to reduce narcotic use (5). Ibuprofen and other NSAIDs are the most effective and most commonly prescribed analgesics for postpartum pain, but clinicians now find themselves stuck between these recommendations and their efforts to limit unnecessary opioid prescriptions. The investigators propose a randomized controlled non-inferiority trial of women with preeclampsia comparing a postpartum analgesic protocol that includes NSAIDs, to one that excludes them. The central hypothesis is that NSAID use does not worsen hypertensive diseases of pregnancy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
287
NSAID pain medication to be used in the experimental bundle for postpartum analgesia
NSAID analgesic to be used in the experimental bundle for postpartum analgesia in patients who underwent cesarean section
Analgesic medication to be used in both treatment arms
Barnes Jewish Hospital
St Louis, Missouri, United States
postpartum antihypertensive requirements
measurement of anti-hypertensive requirements at time of discharge
Time frame: at the end of hospitalization, up to 7 days after randomization
Postpartum pain scores
Evaluate the effect of NSAIDs on patient perception of pain
Time frame: From randomization to 6 weeks after randomization
Postpartum opioid use
Compare the opioid requirements in each arm
Time frame: From randomization to 6 weeks after randomization
Mean arterial blood pressure
Compare peak, average and median MAPs postpartum
Time frame: From randomization to 6 weeks after randomization
End organ damage
Evaluate for evidence of renal, hepatic or neurological injury in the poatpartum period
Time frame: during hospitalization, an average of 4 days
Hospital readmission
Evaluate the incidence of hospital readmission rate postpartum
Time frame: From randomization to 6 weeks after randomization
Continued anti-hypertensive requirement
evaluate the need for antihypertensive medications at 6 weeks postpartum
Time frame: up to 6 weeks
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Analgesic medication to be used in both treatment arms