Screening of Subclinical Hypothyroidism in Pregnant Women

Subclinical Hypothyroidism Clinical Trial

Official title:

Prevalence of Sub-clinical Hypothyroidism Among Pregnant Women During First Trimester: Cross Sectional Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05801822
• Other study ID #: Soh-Med-23-03-02MS
• Status: Not yet recruiting
• Start date: April 1, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2023
• Source: Sohag University
• Contact: Amira M Mahmoud, bachelor
• Phone: 01016308303
• Email: amiramostafa[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

this study may help the physicians to evaluate the practice of universal screening of sub-clinical hypothyroidism and thyroid-stimulating hormone level. Detection of sub-clinical hypothyroidism early in pregnancy through thyroid-stimulating hormone sampling in the first trimester will allow achieving proper management and better maternal and neonatal outcome of these patients.

Description:

This is a cross-sectional study will be carried out on women attending Obstetrics Outpatient Clinic in Sohag University Hospitals between April and 1st December 2023 for the booking antenatal care visit and to be invited to enroll in the study. The attending physician will explain the nature of the study to the cases, the blood samples will be collected and to be assessed for the routine antenatal screening complete blood count, random blood sugar, hepatitis B virus and HIV, the same blood sample will be used to asses TSH level.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 30, 2023
• Est. primary completion date: December 1, 2023
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Age group 18 years to 45 years.

• first trimester pregnant women.

Exclusion Criteria:

• Women with known thyroid disorders or previous thyroidectomy.

• Pregnant women with hyperemesis gravidarum.

• Molar pregnancy.

Related Conditions & MeSH terms

• Hypothyroidism
• Subclinical Hypothyroidism

Intervention

Diagnostic Test:
• serum T.S.H level test
, the blood samples will be collected and to be assessed for the routine antenatal screening CBC, random blood sugar, HBV and HIV, the same blood sample will be used to asses TSH level.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnosis of subclinical hypothyroidism early in pregnancy	by serum TSH level	in the first trimester of pregnancy ( first 12 weeks)