跳至主要内容
临床试验/CTRI/2025/07/091992
CTRI/2025/07/091992尚未招募不适用

ORAL FUROSEMIDE FOR POSTPARTUM MANAGEMENT OF PATIENTS WITH PREGNANCY INDUCED HYPERTENSION

Dr Aneesh Jirge1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年8月7日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
5 day course of postpartum oral furosemide will improve recovery by hastening BP normalisation in women with Pregnancy Induced Hypertension

研究概览

简要总结

With Institutional Ethics Committee clearance and CTRI registration, 80 patients with the above-mentioned inclusion criteria will be recruited in the study.

Admission lists and in patient records will be screened daily to identify eligible patients. Women identified as having a hypertensive disorder of pregnancy will be invited to participate in the study. Protocol will be explained to all the patients and informed consent will be taken.

Relevant history, demographic data, eligibility, past and present medications, adverse event assessment and physical examination will be recorded.

Following randomization by a computer-generated sequence the trial group participants will receive oral furosemide 20 mg OD for the first 5 days of postpartum period with the first dose given with 8 hours of delivery. Patients will receive appropriate antihypertensives as per the hospital unit protocols and oral furosemide will only be an add on drug.  BP and significant clinical features of the trial and control groups will be recorded on the first 5 days and 6-week postnatal care (PNC) visit. Participants unable to visit the institution at 6 weeks postpartum will be encouraged to visit a primary health centre to obtain the BP readings.

Prompt treatment for elevated blood pressures will be initiated as soon as elevated blood pressures are recorded, and will not be delayed for study purposes including study drug administration. Medication used will be as per the treating clinician’s discretion.

There is minimal risk to use of furosemide in the postpartum period. Furosemide is a commonly used drug in postpartum period and prior studies have not shown any adverse effects in this patient population. Committee that overlooks adverse drug reactions at the the hospital who are not investigators on the trial will be utilized to monitor adverse outcomes. All serious adverse effect will be recorded and reported to the institutional review board.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 49.00 Year(s)(—)
性别
Female

入选标准

  • Women more than 18 years of age consenting to participate in the study B.
  • Women diagnosed with hypertensive disorder of pregnancy within the first day postpartum.

排除标准

  • Women less than 18 years of age B.
  • Women allergic to Furosemide C.
  • Chronic hypertensives with no superimposed Preeclampsia D.
  • Those who received diuretics before randomization.

结局指标

主要结局

5 day course of postpartum oral furosemide will improve recovery by hastening BP normalisation in women with Pregnancy Induced Hypertension

时间窗: BP and significant clinical features of the trial and control groups will be recorded on the first 5 days and 6-week postnatal care (PNC) visit

次要结局

  • 1.Decreased need for additional antihypertensives.(2.Reduction in hypertension related postpartum readmissions.)

研究者

发起方
Dr Aneesh Jirge
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Aneesh Jirge

SHRI DHARMASTHALA MANJUNATHESHWARA UNIVERSITY

研究点 (1)

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