Role of Postpartum Furosemide in Recovery of Patients With Severe Preeclampsia
Efficacy of Postpartum Furosemide in Patients With Severe Preeclampsia: A Randomized Controlled Trial
This randomized controlled trial will compare oral furosemide with placebo for improving blood pressure control in women with severe preeclampsia after delivery. Participants will receive either 20 mg of furosemide or a placebo tablet once daily for 5 days, in addition to standard postpartum treatment for high blood pressure. Blood pressure, symptoms, adverse events, and the need for additional antihypertensive medication will be monitored for 7 days after delivery. The study will assess whether adding furosemide helps achieve better postpartum blood pressure control compared with placebo.
研究概览
详细说明
Severe preeclampsia can be associated with persistent or worsening high blood pressure after delivery. This randomized, double-blind, placebo-controlled trial will evaluate the efficacy of oral furosemide as an add-on treatment for postpartum blood pressure control in women with severe preeclampsia.
The study will be conducted in the Department of Obstetrics and Gynaecology, Lady Reading Hospital (MTI), Peshawar. A total of 434 women will be randomized into two groups, with 217 participants in each group. The intervention group will receive oral furosemide 20 mg once daily for 5 days after delivery, while the control group will receive a placebo tablet once daily for 5 days. Both groups will receive standard postpartum antihypertensive management, including monitoring and labetalol when required.
Participants will be followed from delivery through 7 days postpartum. Blood pressure will be monitored daily, including assessment of severe-range hypertension, symptoms, adverse events, and the need for additional antihypertensive medication. The primary assessment of efficacy will be based on achieving blood pressure below 140/90 mmHg on two readings 48 hours apart, without systolic blood pressure reaching 160 mmHg or higher or diastolic blood pressure reaching 110 mmHg or higher, and without requiring an increase in antihypertensive medication through 7 days postpartum.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Dr Qandil Sattar, MBBS
- 电话号码：+923436144247
- 邮箱：qantil.sattar@lrh.edu.pk
研究联系人备份
- 姓名：Dr Syeda Wajeeha, MBBS
- 电话号码：+923436144247
- 邮箱：wajeeha.syed@lrh.edu.pk
学习地点
-
-
Khyber Pakhtunkhwa
-
Peshawar、Khyber Pakhtunkhwa、巴基斯坦、25000
- 招聘中
- Lady Reading Hospital
-
接触：
- Dr Syeda Wajeeha, MBBS
- 电话号码：+923436144247
- 邮箱：wajeeha.syed@lrh.edu.pk
-
接触：
- Dr Qandil Sattar, MBBS
- 电话号码：+923436144247
- 邮箱：qandil.sattar@lrh.edu.pk
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Women aged 18 to 45 years
- Any parity
- Gestational age >28 weeks based on LMP
- Severe preeclampsia as per the study operational definition
Exclusion Criteria:
History of underlying cardiac disease during pregnancy or postpartum
- Pre-existing renal dysfunction or serum creatinine >1.2 mg/dL on medical record
- Significant hypokalemia (K <3 mEq/L) before enrollment
- Known rheumatologic disease or advanced diabetes
- History of allergy to furosemide or prior use of diuretics before randomization
- History of thyroid disorders or other medical illnesses that may interfere with blood pressure management
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Furosemide Group
Participants will receive furosemide 20 mg tablet orally once daily for 5 days after delivery, in addition to standard postpartum antihypertensive treatment, including labetalol when required. |
Furosemide 20 mg tablet administered orally once daily for 5 days after delivery as an add-on to standard postpartum antihypertensive treatment. |
|
安慰剂比较：Placebo Group
Participants will receive a placebo tablet orally once daily for 5 days after delivery, in addition to the same standard postpartum antihypertensive treatment provided to the furosemide group. |
Placebo tablet administered orally once daily for 5 days after delivery, in addition to standard postpartum antihypertensive treatment, including blood pressure monitoring and labetalol when required. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Blood pressure
大体时间：From delivery through 7 days postpartum
|
Proportion of participants achieving blood pressure below 140/90 mmHg on two readings taken 48 hours apart, with no systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg, and no need for an increase in antihypertensive medication from delivery through 7 days postpartum. |
From delivery through 7 days postpartum
|
合作者和调查者
调查人员
- 首席研究员：Dr Qandil Sattar、Lady Reading Hospital Peshawar
- 首席研究员：Dr Syeda Wajeeha、Lady Reading Hospital Peshawar
出版物和有用的链接
一般刊物
- Veena P, Perivela L, Raghavan SS. Furosemide in postpartum management of severe preeclampsia: A randomized controlled trial. Hypertens Pregnancy. 2017 Feb;36(1):84-89. doi: 10.1080/10641955.2016.1239735. Epub 2016 Nov 11.
- Lopes Perdigao J, Lewey J, Hirshberg A, Koelper N, Srinivas SK, Elovitz MA, Levine LD. Furosemide for Accelerated Recovery of Blood Pressure Postpartum in women with a hypertensive disorder of pregnancy: A Randomized Controlled Trial. Hypertension. 2021 May 5;77(5):1517-1524. doi: 10.1161/HYPERTENSIONAHA.120.16133. Epub 2021 Feb 8.
- Pagan M, Ounprpaseuth ST, Ghahremani T, Doiron T, Magann EF. Furosemide for postpartum blood pressure control in patients with hypertensive disorders. Eur J Obstet Gynecol Reprod Biol X. 2023 May 3;18:100195. doi: 10.1016/j.eurox.2023.100195. eCollection 2023 Jun.
- Hup RJ, Paauw ND, Lely AT, Depmann M. Oral antihypertensive agents and diuretics in the management of hypertension in postpartum women: a systematic review and meta-analysis. BMJ Open. 2024 Dec 20;14(12):e086208. doi: 10.1136/bmjopen-2024-086208.
- Steele DW, Adam GP, Saldanha IJ, Kanaan G, Zahradnik ML, Danilack VA, Stuebe AM, Peahl AF, Chen KK, Balk EM. Management of Postpartum Hypertensive Disorders of Pregnancy [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2023 May. Report No.: AHRQ 23-EHC012Report No.: PCORI(R) 2023-SR-02. Available from http://www.ncbi.nlm.nih.gov/books/NBK592560/
- Keiseb J, Moodley J, Connolly CA. Comparison of the efficacy of continuous furosemide and low-dose dopamine infusion in preeclampsia/eclampsia-related oliguria in the immediate postpartum period. Hypertens Pregnancy. 2002;21(3):225-34. doi: 10.1081/PRG-120016787.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 48/LRH/MTI
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
The synopsis only states that participant information will be kept confidential and that access will be limited, with the ethics committee able to review the information when necessary.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.