A Randomized Controlled Trial on the Effects of NSAIDs on Postpartum Blood Pressure in Patients Hypertensive Disorders of Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Average Mean Arterial Blood Pressure- Mild Group
研究概览
简要总结
This study aims to evaluate whether NSAIDs (Non-steroidal antiinflammatory drugs) administered during the postpartum period influence blood pressure in women with hypertensive disorders of pregnancy. The study design is a prospective double blinded randomized control trial with participants randomized to receive postpartum analgesic regimens with and without NSAIDs.
详细描述
Non-steroidal antiinflammatory drugs (NSAIDs) are effective agents for the management of pain in the postpartum period. The addition of NSAIDs to post-cesarean analgesic regimen has been shown to improve post-cesarean pain and reduce opioid requirements. However, concern has been raised over use of NSAIDs in hypertensive pregnant patients, as recent evidence suggests the potential for increased blood pressure in patients with chronic hypertensive disorders receiving these agents. Notably, these studies were conducted on patients with longstanding chronic hypertension, which included males and non-pregnant females, and it is therefore unclear whether this recommendation is appropriate for patients with transient hypertensive disorders of pregnancy.
This protocol describes a randomized trial to evaluate whether NSAIDs influence blood pressure parameters in patients with hypertensive disorders of pregnancy. Patients with severe hypertensive disorders of pregnancy (Severe HDP) will be studied separately from women with mild hypertensive disorders of pregnancy (Mild HDP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Delivery occurred at equal to or greater than 24 0/7 weeks gestational age
- •Patient receiving care with the Women's Perinatal Group (Maternal Fetal Medicine practice) or Obstetric Clinic resident services
- •Diagnosis of a hypertensive disorder of pregnancy (HDP), including the following:
- •Gestational hypertension
- •Preeclampsia without severe features
- •Preeclampsia with severe features
- •Hemolysis, Elevated Liver Enzymes, Low Platelet (HELLP) Syndrome
- •Eclampsia
排除标准
- •Diagnosis of chronic hypertension or documentation of elevated blood pressures before 20 weeks gestational age.
- •Severe hypertension: Patients with at least one severe blood pressure measurement (systolic >160mmHg or diastolic >105mmHg) prior to randomization
- •Renal dysfunction (Serum creatinine measurement >1.3mg/dL during the current pregnancy)
- •Low platelet count (recorded measurement <50,000 during hospital admission)
- •Significant liver dysfunction (AST or ALT >500)
- •Known sensitivities to ibuprofen or acetaminophen
- •Use of therapeutic doses of anticoagulation (low dose anticoagulation used for routine prophylaxis of venous thromboembolism is acceptable)
- •Postpartum hemorrhage requiring transfusion
研究组 & 干预措施
Severe HDP- NSAID
This arm will be assigned a postpartum analgesic regimen with ibuprofen.
干预措施: Ibuprofen (Drug)
Mild HDP- NSAID
This arm will be assigned a postpartum analgesic regimen with ibuprofen.
干预措施: Ibuprofen (Drug)
Severe HDP- No NSAID
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
干预措施: Acetaminophen (Drug)
Mild HDP- No NSAID
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Average Mean Arterial Blood Pressure- Mild Group
时间窗: Averaged from all blood pressures measured through study completion, an average of 3 days
Primary outcome for Hypertensive disorders of pregnancy-Mild Study Group
Primary Outcome for Hypertensive Disorders of Pregnancy- Severe Study Group
时间窗: Through study completion, an average of 3 days
Proportion of participants with at least one episode of severe blood pressure postpartum (systolic \>=160 or diastolic \>=105mmHg) during inpatient postpartum hospitalization
次要结局
- Average Mean Arterial Blood Pressures During Hospital Stay(Averaged from all blood pressures measured through study completion, an average of 3 days)
- Pain Control During Hospital Stay(Through study completion, an average of 3 days)
- Outpatient Blood Pressure Measurement(6 weeks after discharge from the hospital)
- Patient Satisfaction(Through study completion, an average of 3 days)
- Length of Hospital Stay(Through study completion, an average of 3 days)
- Diuresis(Through study completion, an average of 3 days)