The Incidence of Hypocalcemia in Pregnant Women at Siriraj Hospital

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Incidence of Hypocalcemia in Pregnant Women at Siriraj Hospital

Conditions
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Hypocalcemia in Pregnancy

Intervention / Treatment
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* Drug: Calcium supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women who attend antenatal care clinic in Siriraj Hospital Pregnant women with gestation less than 20 weeks of gestation Singleton pregnancy Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Normal calcium level with no receiving calcium supplement<br>Pregnant women with normal calcium level in the first half of pregnancy do not receive calcium supplement. | |
| Experimental: Normal calcium level with receiving calcium supplement 1g/day<br>Pregnant women with normal calcium level in the first half of pregnancy receive calcium supplement 1g/day. | Drug: Calcium supplement<br>* Different amount of calcium supplement in pregnancy<br>|
| Experimental: Hypocalcemia with receiving calcium supplement 1g/day<br>Pregnant women with hypocalcemia in the first half of pregnancy receive calcium supplement 1g/day. | Drug: Calcium supplement<br>* Different amount of calcium supplement in pregnancy<br>|
| Experimental: Hypocalcemia level with receiving calcium supplement 2g/day<br>Pregnant women with hypocalcemia in the first half of pregnancy receive calcium supplement 2g/day. | Drug: Calcium supplement<br>* Different amount of calcium supplement in pregnancy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of hypocalcemia in pregnant women at Siriraj Hospital | 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. | 1.5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | The different characteristics between normal calcium and hypocalcemia group in the first half of pregnancy will be studied. The data will be received by interviewing the patients, answering the questionnaire and scrupulous chart review; including age, education, occupations, income, marital status, food and nutrition status, previous pregnancy outcomes, family history, mode of conception in this pregnancy, gestational age of blood drawing, caffeine intake, smoking, and maternal hematocrit. | 1.5 year | 
| The calcium level in pregnant women in the third trimester | Comparison of maternal serum calcium level in pregnant women in the third trimester between who receive and do not receive calcium supplement. In the normal calcium level group, pregnant women will be divided into 2 groups: receiving CaCO3 1 g/day and no receiving. In the hypocalcemia group, pregnant women will be divided into 2 groups: receiving CaCO3 1g/day and 2g/day. Maternal blood taking for serum calcium level will be done in all participants. Comparison of maternal calcium level between groups will be reported. Statistical analysis will be used t-test and p-value is less than 0.5. | 2 year |