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Clinical Trials/NCT06160479
NCT06160479
Active, not recruiting
Not Applicable

The Incidence of Hypocalcemia in Pregnant Women at Siriraj Hospital

Siriraj Hospital1 site in 1 country444 target enrollmentMay 5, 2022

Overview

Phase
Not Applicable
Intervention
Calcium supplement
Conditions
Hypocalcemia in Pregnancy
Sponsor
Siriraj Hospital
Enrollment
444
Locations
1
Primary Endpoint
The incidence of hypocalcemia in pregnant women at Siriraj Hospital
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
May 5, 2022
End Date
May 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tachjaree Panchalee

Assistant Professor Tachjaree Panchalee

Siriraj Hospital

Eligibility Criteria

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

Arms & Interventions

Normal calcium level with receiving calcium supplement 1g/day

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

Intervention: Calcium supplement

Hypocalcemia with receiving calcium supplement 1g/day

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

Intervention: Calcium supplement

Hypocalcemia level with receiving calcium supplement 2g/day

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

Intervention: Calcium supplement

Outcomes

Primary Outcomes

The incidence of hypocalcemia in pregnant women at Siriraj Hospital

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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