NSAID Use in Postpartum Hypertensive Women
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in the Mean Systolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2.
研究概览
简要总结
Women who have the diagnosis of hypertension (pre-pregnancy and pregnancy induced) and deliver an infant via vaginal delivery will be placed into two groups in the postpartum period. One group will receive Ibuprofen for pain control and the other group will be given Tylenol. Blood pressures during the postpartum period will then be collected and compared in order to see if NSAIDs use increases blood pressure.
详细描述
The patients who have a vaginal delivery and have the diagnosis of hypertension in pregnancy will be randomized to either Ibuprofen use or acetaminophen use during the postpartum period. Standard blood pressure monitoring in the postpartum period will be followed to help determine if there is a significant rise in the women who use NSAIDS in the postpartum period versus those that use acetaminophen.
Groups will be divided into women with chronic hypertension, women with chronic hypertension with superimposed preeclampsia, women with preeclampsia without severe features, women with preeclampsia with severe features, women with gestational hypertension without severe range blood pressures, and women with gestational hypertension with severe range blood pressures.
Recruitment will last 36 months. Patients will be monitored during their postpartum stay (typical 2 days) with blood pressure measurements. An additional 12 months will be needed for data analysis and publication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 14 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •vaginal delivery
- •diagnosis of chronic hypertension, chronic hypertension with superimposed preeclampsia
- •preeclampsia without severe features
- •preeclampsia with severe features gestational hypertension without severe range blood pressures
- •gestational hypertension with severe range blood pressures
- •singleton pregnancies
排除标准
- •Cesarean Delivery
- •no diagnosis of hypertensive disorder
- •chronic or acute renal disease
- •allergy to ibuprofen or acetaminophen
- •multiple order pregnancies (twins, triplets)
- •Narcotic addiction/ in treatment for substance abuse/ current prescription drug user/ current use of illegal drugs
研究组 & 干预措施
Acetaminophen
Patients will be monitored for change in blood pressure
干预措施: Acetaminophen (Drug)
NSAID
Patients will be monitored during their postpartum stay (typical 2 days) and then again at 1 week and 6 weeks (standard practice of care) with blood pressure measurements
干预措施: NSAID (Drug)
结局指标
主要结局
Change in the Mean Systolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2.
时间窗: 2 days
To determine if NSAIDS in the postpartum period raise blood pressure in women with a hypertensive disorder. The mean increase and standard deviation of each group (acetaminophen and NSAID/Ibupforen) was calculated when compairing systolic blood pressures from the first postpartum day to the second postpartum day. Day 1 is the mean of systolic blood pressures from 0 hours to 23 hours after delivery, and Day 2 is the mean of systolic blood pressures from 24 hours to 47 hours after delivery.
次要结局
- Change in the Mean Diastolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2.(2 days)
研究者
Jennifer Goldkamp, MD
MD
St. Louis University