Subclinical HypothyroidismNCT05801822
Screening of Subclinical Hypothyroidism in Pregnant Women
An observational study of Subclinical Hypothyroidism, run by Sohag University.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Subclinical Hypothyroidism
- What is being tested?
- serum T.S.H level test
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Adult
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.
Who may be able to join
- Age group 18 years to 45 years.
- first trimester pregnant women.
Who cannot join
- Women with known thyroid disorders or previous thyroidectomy.
- Pregnant women with hyperemesis gravidarum.
- Molar pregnancy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Subclinical Hypothyroidism
- Being tested
- serum T.S.H level test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis of subclinical hypothyroidism early in pregnancy
by serum TSH level
Measured: in the first trimester of pregnancy ( first 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subclinical HypothyroidismStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mostafa Mahmoud, Sohag University
- Investigators
- Amira M Mahmoud, bachelor, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801822
- Sponsor's protocol ID
- Soh-Med-23-03-02MS
- Status last verified
- Mar 2023
- First submitted
- 25 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Sub-clinical Hypothyroidism Among Pregnant Women During First Trimester: Cross Sectional Study.
- ClinicalTrials.gov ID
- NCT05801822
- Acronym / sponsor ID
- Soh-Med-23-03-02MS
- Conditions
- Subclinical Hypothyroidism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Age group 18 years to 45 years.
- first trimester pregnant women.
Key exclusion criteria (3 listed)
- Women with known thyroid disorders or previous thyroidectomy.
- Pregnant women with hyperemesis gravidarum.
- Molar pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | – |
Primary outcome
diagnosis of subclinical hypothyroidism early in pregnancy
Time frame: in the first trimester of pregnancy ( first 12 weeks)
by serum TSH level
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Subclinical Hypothyroidism
Not yet recruitingObservational study
Impact of Overt and Subclinical Hypothyroidism on Liver Fibrosis in Patients With MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease, Non-Alcoholic Fatty Liver Disease
Not yet recruitingObservational study
Subclinical Hypothyroidism and Disease Activity in Rheumatoid Arthritis
Rheumatoid Arthritis, Subclinical Hypothyroidism
Not yet recruitingObservational study
Hypothyroidism and Liver Fibrosis Severity in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease, Hypothyroidism
Not yet recruitingPhase 4
Discontinuation of Low-Dose Levothyroxine in Older Adults With Subclinical Hypothyroidism
Hypothyroidism
Recruiting
Levothyroxine Treatment on Cardiac Function in Children With Subclinical Hypothyroidism
Levothyroxine, Cardiac Function
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amira M Mahmoud, bachelor principal investigator
Sohag University
Questions about this trial
What is this clinical trial studying?
An observational study of Subclinical Hypothyroidism, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amira M Mahmoud, bachelor (01016308303 ext. 02, amiramostafa@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnosis of subclinical hypothyroidism early in pregnancy (time frame: in the first trimester of pregnancy ( first 12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.