跳至主要内容
临床试验/CTRI/2024/02/063264
CTRI/2024/02/063264尚未招募不适用

To study the correlation between ultrasound guided optic nerve sheath diameter measurements with respect to timing of stopping of magnesium sulphate therapy, in pre-eclamptic patients with severe features – a prospective, observational, pilot study

未提供1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年3月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
A high optic nerve sheath diameter value (≥ 5.8 mm) is expected in patients presenting with pre-eclampsia with severe features at various time points in the post natal period even after stopping of MgSO4 therapy.

研究概览

简要总结

All eligible patients will be explained about the study. Baseline ultrasound guided optic nerve sheath diameter will be recorded prior to starting of MgSO4, date and time of starting MgSO4 will be noted .Subsequently optic nerve sheath diameter will be measured after 6 hours of starting MgSO4 therapy , thereafter immediately after delivery and thereafter 12 hours, 24 hours and 48 hours after delivery. Date and timing of stopping of MgSO4 will be noted.

A high ONSD value (≥ 5.8 mm) is expected in patients presenting with pre-eclampsia with severe features at various time points in the post natal period even after stopping of MgSO4 therapy.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Pregnant patients aged ≥18 years Period of gestation ≥ 20 weeks Presenting with pre-eclampsia with severe features Patients who will receive MgSO4 therapy Planned for termination of pregnancy.

排除标准

  • Patient’s refusal Eclamptic patients Patient who receives MgSO4 prior to first reading of optic nerve sheath diameter.
  • Patients who have undergone previous cranial or eye surgeries Patients suffering from seizures, intracranial or eye pathology, glaucoma or any other neurological condition.
  • Patients with uncontrolled diabetes or cardiac disease.

结局指标

主要结局

A high optic nerve sheath diameter value (≥ 5.8 mm) is expected in patients presenting with pre-eclampsia with severe features at various time points in the post natal period even after stopping of MgSO4 therapy.

时间窗: Ultrasound guided optic nerve sheath diameter assessment will be done prior to start of MgSO4 therapy and baseline value will be noted. Thereafter, ultrasound guided optic nerve sheath diameter assessment will be done at 6 hour time point after | starting of MgSO4. Subsequent values will be noted immediately after delivery and thereafter at 12 hour, 24 hour and 48 hour time point after delivery.

次要结局

未报告次要终点

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Rakesh Subudhi

AIIMS, Raipur

研究点 (1)

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