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Screening of Subclinical Hypothyroidism in Pregnant Women

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05801822
Collaborator
(none)
100
Enrollment
9
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: serum T.S.H level test

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Prevalence of Sub-clinical Hypothyroidism Among Pregnant Women During First Trimester: Cross Sectional Study.
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Outcome Measures

Primary Outcome Measures

  1. diagnosis of subclinical hypothyroidism early in pregnancy [in the first trimester of pregnancy ( first 12 weeks)]

    by serum TSH level

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sohag University

Investigators

  • Principal Investigator: Amira M Mahmoud, bachelor, Sohag University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amira Mostafa Mahmoud, resident doctor, Sohag University
ClinicalTrials.gov Identifier:
NCT05801822
Other Study ID Numbers:
  • Soh-Med-23-03-02MS
First Posted:
Apr 6, 2023
Last Update Posted:
Apr 6, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hypothyroidism

Study Results

No Results Posted as of Apr 6, 2023