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The Incidence of Hypocalcemia in Pregnant Women at Siriraj Hospital

The Incidence of Hypocalcemia in Pregnant Women at Siriraj Hospital

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06160479
Acronym
HypoCal
Enrollment
444
Registered
2023-12-07
Start date
2022-05-05
Completion date
2024-05-31
Last updated
2023-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypocalcemia in Pregnancy

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.

Interventions

Different amount of calcium supplement in pregnancy

Sponsors

Siriraj Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The incidence of hypocalcemia in pregnant women at Siriraj Hospital1.5 yearThe 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

MeasureTime frameDescription
The demographic and pregnant factors are associating with maternal calcium level in the first half of pregnancy assessed by the questionnaire and scrupulous chart review1.5 yearThe 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.
The calcium level in pregnant women in the third trimester2 yearComparison 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.

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026