A Randomized-controlled Trial to Assess the Effect of Ibuprofen on Post-partum Blood Pressure in Women With Hypertensive Disorders of Pregnancy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Difference in Systolic Blood Pressure (SBP)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Ibuprofen followed by acetaminophen
Ibuprofen administered immediately post-partum, 600 mg (3 x 200 mg tablets) every 6 hours for 24 hours followed by acetaminophen, 650 mg (2 x 325 mg tablets) every 6 hours for 24 hours.
干预措施: Ibuprofen (Drug)
Ibuprofen followed by acetaminophen
Ibuprofen administered immediately post-partum, 600 mg (3 x 200 mg tablets) every 6 hours for 24 hours followed by acetaminophen, 650 mg (2 x 325 mg tablets) every 6 hours for 24 hours.
干预措施: Acetaminophen (Drug)
Acetaminophen followed by ibuprofen
Acetaminophen administered immediately post-partum, 650 mg (2 x 325 mg tablets) every 6 hours for 24 hours followed by ibuprofen, 600 mg (3 x 200 mg tablets) every 6 hours for 24 hours.
干预措施: Ibuprofen (Drug)
Acetaminophen followed by ibuprofen
Acetaminophen administered immediately post-partum, 650 mg (2 x 325 mg tablets) every 6 hours for 24 hours followed by ibuprofen, 600 mg (3 x 200 mg tablets) every 6 hours for 24 hours.
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Difference in Systolic Blood Pressure (SBP)
时间窗: 24 hours following intervention
The adjusted mean difference in systolic blood pressure after 24 hours of exposure each to ibuprofen and acetaminophen.
次要结局
- Change in Self-reported Pain Score 2 Hours After First Intervention(At the time of first dose of study drug and 2 hours after)
- Mean Pain Score by Nursing Assessment(0-24 hours and 24-48 hours after initial study medication administration)
- Satisfaction With Pain Control During 24 Hours of Exposure Each to Ibuprofen and Acetaminophen(24 hours and 48 hours after initial study medication administration)
研究者
Elizabeth Langen
Assistant Professor of Obstetrics and Gynecology
University of Michigan