Screening of Subclinical Hypothyroidism in Pregnant Women

March 25, 2023 updated by: Amira Mostafa Mahmoud, Sohag University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

This is a cross-sectional study will be carried out on women attending Obstetrics Outpatient Clinic in Sohag University Hospitals for the booking antenatal care visit.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diagnosis of subclinical hypothyroidism early in pregnancy
Time Frame: in the first trimester of pregnancy ( first 12 weeks)
by serum TSH level
in the first trimester of pregnancy ( first 12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

March 25, 2023

First Submitted That Met QC Criteria

March 25, 2023

First Posted (Actual)

April 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

March 25, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-23-03-02MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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