Lasix for the Prevention of De Novo Postpartum Hypertension: A Randomized Controlled Trial (LAPP Trial)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Mean Arterial Blood Pressure (MAP)
研究概览
简要总结
Primary objective: To evaluate whether oral furosemide can help prevent de novo postpartum hypertension (new-onset high blood pressure after delivery) by reducing blood pressure after delivery in high-risk women.
Secondary objectives: To evaluate whether oral furosemide administered to high-risk women after delivery can reduce the frequency of postpartum hypertensive episodes, the need for antihypertensive therapy, the risk of postpartum preeclampsia, and the incidence of severe maternal morbidity.
详细描述
Hypertensive disorders of pregnancy are one of the leading causes of maternal morbidity and mortality worldwide. The majority of clinical research has focused on pregnancy-related hypertension that develops in the antenatal period, while studies of the incidence, risk factors, and prevention of postpartum hypertension are limited. In particular, there is a paucity of data about the clinical entity known as de novo postpartum hypertension, in which women who are normotensive throughout pregnancy and delivery subsequently go on to develop high blood pressure in the immediate to late postpartum period. Of those with postpartum preeclampsia, 33-69% were normotensive antepartum.
Early identification and treatment of antepartum preeclampsia has been shown to decrease some severe maternal outcomes. Conversely, women with de novo postpartum hypertensive disorders remain among the highest risk for severe maternal morbidity due to decreased surveillance and lack of data regarding preventive therapies and interventions. Evidence from multiple randomized controlled trials have demonstrated a benefit in the use of oral loop-diuretics in decreasing postpartum systolic blood pressure, promoting faster normalization of blood pressure, and decreasing the need for antihypertensive therapy in women with an antenatal diagnosis of preeclampsia. Biological plausibility suggests that loop-diuretic therapy may similarly mitigate the normal physiologic mechanism that has been implicated in the pathogenesis of hypertensive complications after delivery in women at risk for de novo postpartum hypertension.
This study is a double-blind randomized placebo-controlled trial of 82 high-risk women to assess whether treatment with oral Lasix (furosemide) after delivery reduces blood pressure at the time of discharge. Women at high risk for de novo postpartum hypertension will be randomized to a five-day course of either 20 mg oral Lasix (furosemide) or placebo once daily initiated after delivery. Women will be monitored through their routine 2-week and 6-week postpartum visits, during which times hypertensive complications and adverse effects of therapy will be assessed.
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)
盲法说明
Consenting women will be assigned to Lasix (furosemide) or placebo in a 1:1 ratio according to a randomization scheme achieved using a computer generated algorithm. Neither the participant nor the clinical care team will be aware of the allocation arm.
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
- •No antenatal diagnosis of hypertensive disorder of pregnancy at the time of admission for delivery, defined as existing chronic hypertension diagnosis or documented blood pressure of ≥140 systolic OR ≥90 diastolic on at least 2 occasions at least 4 hours apart prior to delivery admission who do not go on to get magnesium for seizure prophylaxis by the time of delivery
- •At least 18 years of age
- •English or Spanish speakers
- •One or more high risk factors for development of de novo postpartum hypertension
排除标准
- •Non-English or Spanish speakers
- •Women with a contraindication to diuretic therapy
- •Women who have used diuretics in the two weeks prior to delivery
研究组 & 干预措施
Lasix (furosemide)
Furosemide 20 mg, oral, once daily for 5 days
干预措施: Furosemide (Drug)
Placebo
Identical-appearing placebo, oral, once daily for 5 days
干预措施: Placebo (Other)
结局指标
主要结局
Mean Arterial Blood Pressure (MAP)
时间窗: 24 hours prior to discharge through discharge, up to 7 days
Difference in MAP averaged over the 24 hours prior to discharge or the 24 hours prior to antihypertensive therapy initiation (whichever occurs first)
次要结局
- Time to Discharge(Randomization through discharge, up to 7 days)
- Rate of de Novo Postpartum Preeclampsia(Discharge (up to 7 days), 2 weeks postpartum, 6 weeks postpartum)
- Percent of Recorded Blood Pressures That Are Elevated(Discharge (up to 7 days), 2 weeks postpartum, 6 weeks postpartum)
- Rate of Magnesium Sulfate Administration(Discharge (up to 7 days), 2 weeks postpartum, 6 weeks postpartum)
- Rate of Initiation of Antihypertensives(Discharge (up to 7 days), 2 weeks postpartum, 6 weeks postpartum)
- Rate of Severe Maternal Morbidity(Discharge (up to 7 days), 2 weeks postpartum, 6 weeks postpartum)
- Rate of Triage or Emergency Department (ED) Presentation/Readmission(2 weeks postpartum, 6 weeks postpartum)
- Breastfeeding Continuation Rate(2 weeks postpartum, 6 weeks postpartum)