Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension: A Comparative Effectiveness Pilot Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Number of Participants With Stage 2 Hypertension
研究概览
简要总结
The purpose of this study is to see if a combined pill of Angiotensin-converting enzyme (ACE) inhibitors (a medication that helps relax your veins and arteries to lower your blood pressure) with diuretics (sometimes called water pills, help rid your body of salt and water) will control blood pressure better than a different blood pressure medication of calcium channel blocker (lower your blood pressure by preventing calcium from entering the cells of your heart and arteries). Both medications are part of our usual care for high blood pressure after delivery.
详细描述
In individuals with preeclampsia, persistent hypertension and edema result in part from the mobilization of up to 8 liters of fluid and sodium from the extravascular to intravascular space. The increased urinary sodium excretion on days 3-5 postpartum likely results from higher atrial natriuretic peptide concentrations in plasma and activation of the renin-angiotensin-aldosterone system. Adding diuretics for postpartum hypertension has been associated with better blood pressure control in some of the studies.
- CVD is the leading cause for mortality worldwide.
- Primary prevention is more effective than treating CVD.
- Pregnancy is often the 1st adult engagement with the healthcare system.
- Preeclampsia is a risk factor for long term CVD, even after controlling for mutual risk factors.
- CVD is the leading cause for pregnancy related mortality.
- There is no good data regarding the optimal medications to control blood pressure after delivery.
- ACE inhibitors play an important role in controlling blood pressure outside of pregnancy and there is extensive evidence to support their cardioprotective effects.
- The optimal use of diuretics in the postpartum in patients with preeclampsia, require further study and clarification to augment current management schemes.
Hypothesis
that in postpartum women with hypertensive disorders, oral combined Hydrochlorothiazide/Lisinopril will reduce postpartum hypertension at 7 days after delivery compared to usual care with calcium channel blockers.
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
- None
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
- •Postpartum women at ≥ 18 years of age
- •Postpartum diagnosis of persistent hypertension (2 measurements of Systolic BP ≥150 and/or diastolic BP ≥ 100 or systolic BP ≥140 and/or diastolic BP ≥ 90 for people with diabetes) requiring an oral medication based on the ACOG criteria or
- •Hypertensive disorder of pregnancy diagnosed antepartum or intrapartum requiring blood pressure medication in the postpartum
- •Chronic hypertension requiring blood pressure medication postpartum
排除标准
- •Urine output < 30 cc/h prior to screening for eligibility
- •Creatinine > 1.4 during current admission
- •End-stage renal disease
- •Hypersensitivity to ACE inhibitors or sulfa drugs
- •Idiopathic/hereditary angioedema
- •Hyperkalemia (serum potassium >5 mEq/L) during current admission
- •Pulmonary edema
研究组 & 干预措施
Extended release nifedipine
calcium channel blocker (Nifedipine
干预措施: NIFEdipine ER (Drug)
Hctz/Lisinopril
Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril)
干预措施: ACE Inhibitors and Diuretics (Drug)
结局指标
主要结局
Number of Participants With Stage 2 Hypertension
时间窗: 7-10 after delivery
Stage 2 hypertension at day 7-10 after delivery (defined as SBP ≥ 140 and/or DBP ≥ 90 mmHg) or admission to the hospital for blood pressure control prior to day 10. Primary outcome will be calculated as the average BP reading for day 7-10 after delivery.
次要结局
- Incidence of Persistent Postpartum Hypertension(6 weeks postpartum)
- Number of Participants With Severe Postpartum Hypertension(7-10 after delivery)
- Number of Participants Who Received Additional Antihypertensive During Admission(7-10 days postpartum)
- Postpartum Length of Stay(up to 30 days after delivery)
- Postpartum Readmission(up to 30 days after delivery)
- Time to Blood Pressure Control(10 days)
- Occurrence of Proteinuria(7-10 days, and 6 weeks postpartum)
- Presense of Labs Abnormality(7-10 days, and 6 weeks postpartum)
- Compliance With Medications(at the time of the 1st postpartum clinic visit, which is about 6 to 37 days after birth)
- Time to Control Blood Pressure(3 month-1 year)
- Number of Patients Receiving Primary Care With BP Measurement(1 year postpartum)
- Postpartum Complications- Number of Participants With ICU Admission(10 days postpartum)
- Postpartum Complications- Number of Participants With HELLP (Hemolysis, Elevated Liver Enzymes and Low Platelets) Syndrome(10 days postpartum)
- Postpartum Complications- Number of Participants With Eclampsia(10 days postpartum)
- Postpartum Complications- Number of Participants With Stroke(10 days postpartum)
- Postpartum Complications- Number of Participants With Renal Failure(10 days postpartum)
- Postpartum Complications- Number of Participants With Pulmonary Edema(10 days postpartum)
- Postpartum Complications - Number of Participants With Cardiomyopathy(10 days postpartum)
- Postpartum Complications- Number of Participants With Maternal Death(10 days postpartum)
- Receipt of Additional Antihypertensive During Admission(6 weeks postpartum)
研究者
Michal Fishel Bartal
Assistant Professor
The University of Texas Health Science Center, Houston