The Incidence of Hypocalcemia in Pregnant Women at Siriraj Hospital

NCT06160479 | Unknown

• 1 other identifier: Si 1003/2021
• Study Type: interventional
• Target: 444
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypocalcemia in Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 Arms (4)

Normal calcium level with no receiving calcium supplement

NO INTERVENTION

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

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

Drug: Calcium supplement

Hypocalcemia with receiving calcium supplement 1g/day

EXPERIMENTAL

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

Drug: Calcium supplement

Hypocalcemia level with receiving calcium supplement 2g/day

EXPERIMENTAL

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

Drug: Calcium supplement

Interventions

Calcium supplement DRUG

Different amount of calcium supplement in pregnancy

Hypocalcemia level with receiving calcium supplement 2g/day; Hypocalcemia with receiving calcium supplement 1g/day; Normal calcium level with receiving calcium supplement 1g/day

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Siriraj Hospital: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

Study Officials

• Tachjaree Panchalee, MD

  Siriraj Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Tachjaree Panchalee

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 7, 2023
• Study Start: May 5, 2022
• Primary Completion: September 12, 2023
• Study Completion: May 31, 2024
• Last Updated: December 7, 2023

Record last verified: 2023-12

Locations

TH (1)