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临床试验/NCT06160479
NCT06160479进行中(未招募)不适用

The Incidence of Hypocalcemia in Pregnant Women at Siriraj Hospital

Siriraj Hospital1 个研究点 分布在 1 个国家目标入组 444 人开始时间: 2022年5月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
444
试验地点
1
主要终点
The incidence of hypocalcemia in pregnant women at Siriraj Hospital

研究概览

简要总结

Calcium is an essential element for fundamental physiological functions and during pregnancy. However, higher calcium intake can induce constipation, flatulence, nausea, or kidney stones. This study aims to evaluate the incidence of hypocalcemia among pregnant women in the first half of pregnancy in Thailand. Also, Comparison of calcium level in pregnant women in the third trimester who received and not received calcium during pregnancy.

详细描述

The primary outcome is the incidence of hypocalcemia among pregnant women in the first half of pregnancy. This study also has secondary objectives. The one is associating factors with calcium level. After getting the results of maternal calcium level, the normal calcium level group will be divided into 2 groups for receiving calcium 1 g/day and no receiving calcium supplement. Another with hypocalcemia group will be decided into 2 groups for receiving calcium 1 g/day and 2 g/day. The calcium level was collected again in the third trimester.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women who attend antenatal care clinic in Siriraj Hospital
  • Pregnant women with gestation less than 20 weeks of gestation
  • Singleton pregnancy

排除标准

  • Pregnant women who has underlying diseases including liver disease and vitamin D deficiency
  • Pregnant women are malnutrition patients
  • Pregnant women who receive calcium supplement before enrollment

研究组 & 干预措施

Normal calcium level with receiving calcium supplement 1g/day

Experimental

Pregnant women with normal calcium level in the first half of pregnancy receive calcium supplement 1g/day.

干预措施: Calcium supplement (Drug)

Hypocalcemia with receiving calcium supplement 1g/day

Experimental

Pregnant women with hypocalcemia in the first half of pregnancy receive calcium supplement 1g/day.

干预措施: Calcium supplement (Drug)

Hypocalcemia level with receiving calcium supplement 2g/day

Experimental

Pregnant women with hypocalcemia in the first half of pregnancy receive calcium supplement 2g/day.

干预措施: Calcium supplement (Drug)

结局指标

主要结局

The incidence of hypocalcemia in pregnant women at Siriraj Hospital

时间窗: 1.5 year

The incidence of hypocalcemia in pregnant women in the first half of pregnancy. Material blood will be taken for calcium level. The hypocalcemia is defined as total calcium level less than 8.5 mg/dl.

次要结局

  • The demographic and pregnant factors are associating with maternal calcium level in the first half of pregnancy assessed by the questionnaire and scrupulous chart review(1.5 year)
  • The calcium level in pregnant women in the third trimester(2 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tachjaree Panchalee

Assistant Professor Tachjaree Panchalee

Siriraj Hospital

研究点 (1)

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