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临床试验/CTRI/2025/11/097359
CTRI/2025/11/097359尚未招募不适用

Comparison of serum calcium-magnesium ratio in women with and without Preeclampsia

Dr Neha Thawale1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2025年11月25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
160
试验地点
1
主要终点
calcium to magnesium ratio in maternal samples

研究概览

简要总结

A prospective comparative study will be performed in the Department of Obstetrics and Gynaecology, ABVIMS and Dr RML Hospital, NEW DELHI. Pregnant women admitted to the maternity ward of the department with the diagnosis of PE shall be screened. Those found meeting the inclusion and exclusion criteria shall be recruited after detailed written informed consent to participate. History, examination and clinical management shall be recorded as per attached proforma. Gestational age shall be determined by patients last menstrual period for those who are sure of her dates with regular cycles, otherwise it will be by measurement of foetal crown rump length at 11-13 weeks and 6 days or by the foetal trans-cerebellar diameter at 19-24 weeks.

Recruited patients shall have their serum samples taken for measurement of total calcium and magnesium levels and their ratio shall be recorded. The recruited patients shall be managed as per hospital protocol and followed up until delivery.

Sample for calcium and magnesium shall be taken from age and gestational age matched controls attending the antenatal OPD of the department. Serum calcium – magnesium ratio shall be recorded and compared in women with pre-eclampsia and normotensive pregnant women.

Both groups shall be followed until birth and pregnancy outcome shall be recorded as per the proforma. Feto-maternal outcome shall be compared in women who develop pre- eclampsia and normotensive pregnant women. In addition, cord blood samples shall be collected to assess levels of serum calcium and magnesium. 1.0 millilitres of venous cord blood shall be collected in heparinised vials and total calcium and magnesium shall be sent to the laboratory for measurement using blood gas analyser. The values shall be compared.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • Singleton live pregnancy with Preeclampsia.

排除标准

  • Any chronic medical disorders such as chronic hypertension, autoimmune disease, APLA, chronic renal disease, thyroid disease, diabetes,women on magnesium supplements, known aneuploidy or gross congenital malformation in the baby.

结局指标

主要结局

calcium to magnesium ratio in maternal samples

时间窗: at the time of delivery

次要结局

  • calcium to magnesium ratio in cord blood(birth weight)

研究者

发起方
Dr Neha Thawale
申办方类型
Other [Dr. Neha Thawale]
责任方
Principal Investigator
主要研究者

Neha Thawale

RML HOSPITAL

研究点 (1)

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