The Incidence of Hypocalcemia in Pregnant Women at Siriraj Hospital (HypoCal)

Siriraj Hospital

Status: Active, not recruiting

Conditions: Hypocalcemia in Pregnancy

Treatments: Drug: Calcium supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT06160479

Si 1003/2021

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 444 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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444 participants in 4 patient groups

Normal calcium level with no receiving calcium supplement

No Intervention group

Description:

Pregnant women with normal calcium level in the first half of pregnancy do not receive calcium supplement.

Normal calcium level with receiving calcium supplement 1g/day

Experimental group

Description:

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

Treatment:

Drug: Calcium supplement

Hypocalcemia with receiving calcium supplement 1g/day

Experimental group

Description:

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

Treatment:

Drug: Calcium supplement

Hypocalcemia level with receiving calcium supplement 2g/day

Experimental group

Description:

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

Treatment:

Drug: Calcium supplement