NCT05801822

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

April 6, 2023

Status Verified

March 1, 2023

Enrollment Period

8 months

First QC Date

March 25, 2023

Last Update Submit

March 25, 2023

Conditions

Subclinical Hypothyroidism

Outcome Measures

Primary Outcomes (1)

  • diagnosis of subclinical hypothyroidism early in pregnancy

    by serum TSH level

    in the first trimester of pregnancy ( first 12 weeks)

Interventions

serum T.S.H level testDIAGNOSTIC_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.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailssubclinical hypothyroidism in pregnant women
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • Age group 18 years to 45 years.
  • first trimester pregnant women.

You may not qualify if:

  • Women with known thyroid disorders or previous thyroidectomy.
  • Pregnant women with hyperemesis gravidarum.
  • Molar pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Amira M Mahmoud, bachelor

    Sohag University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amira M Mahmoud, bachelor

CONTACT

01016308303amiramostafa@med.sohag.edu.eg

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

March 25, 2023

First Posted

April 6, 2023

Study Start

April 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 30, 2023

Last Updated

April 6, 2023

Record last verified: 2023-03