Subclinical HypothyroidismNCT01838031
Thyroid Screening Protocol During Pregnancy: a Multi-center Prospective Controlled Study
A study testing thyroid screening in people with Subclinical Hypothyroidism, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Estimate the proper thyroid screening method during pregnancy. Evaluate if maternal subclinical hypothyroidism treatment during pregnancy result in improved pregnancy outcome and cognitive function in the children. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Subclinical Hypothyroidism
- What is being tested?
- thyroid screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Sep 2011to Sep 2013
- Phase
- Interventional
- 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 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All of the pregnant women who receive prenatal care in PUMCH and HMCHH
- Sign the consent form
- agree to follow-up the pregnancy outcome and child
Who cannot join
- the pregnant women who do not agree to enter the study
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Randomized Thyroid Screening Protocol During Pregnancy: a Multi-center Prospective Controlled Study
Estimate the proper thyroid screening method during pregnancy. Evaluate if maternal subclinical hypothyroidism treatment during pregnancy result in improved pregnancy outcome and cognitive function in the children.
Read the detailed description
The investigators conducted a single-blinded trial in which pregnant women at a gestation of less than 12 weeks, usually 6 to 8 weeks, provided blood samples for measurement of thyrotropin, free thyroxine(FT4) and thyroid peroxidase antibody (TPOAb). Women were assigned to a screening group in PUMCH (in which measurements were obtained immediately) or a control group in HMCHH (in which serum was stored and measurements were obtained shortly after delivery). Each group enrolled 1000 pregnant women separately. Women with positive findings in the screening group were given individualized levothyroxine treatment and regular follow-up. Compare the pregnancy outcomes, IQ at 2-3 years of age in children of women with subclinical hypothyroidism between two groups.
- Conditions
- Subclinical Hypothyroidism
- Being tested
- thyroid screening
- Keywords
- antenatal thyroid screening, subclinical hypothyroidism, thyroid function, thyroid antibody, pregnancy outcome, childhood cognitive function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thyroid screeningOther
The thyroid function and antibody will be measured immediately. The subclinical hypothyroidism will be treated individually.
| Study group | Role | What they receive |
|---|---|---|
| the control group | No intervention | The serum will be stored and the measurements will be obtained after the delivery |
| the thyroid screening group | Active comparator | The thyroid function and antibody will be measured during pregnancy. The subclinical hypothyroidism will be treated individually. Receives: Other: thyroid screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events
the number of miscarriage，preeclampsia，gestational diabetes，prererm birth and postpartum hemorrhage
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startSep 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Subclinical HypothyroidismStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission
- Responsible party
- Principal investigator, Liangkun Ma, Peking Union Medical College Hospital
- Investigators
- Liangkun Ma, MD, Study director, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838031
- Sponsor's protocol ID
- Z111107058811025
- Status last verified
- Nov 2013
- First submitted
- 14 Apr 2013
- Last updated
- 26 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bahn Chair RS, Burch HB, Cooper DS, Garber JR, Greenlee MC, Klein I, Laurberg P, McDougall IR, Montori VM, Rivkees SA, Ross DS, Sosa JA, Stan MN; American Thyroid Association; American Association of Clinical Endocrinologists. Hyperthyroidism and other causes of thyrotoxicosis: management guidelines of the American Thyroid Association and American Association of Clinical Endocrinologists. Thyroid. 2011 Jun;21(6):593-646. doi: 10.1089/thy.2010.0417. Epub 2011 Apr 21.
PubMed 21510801Lazarus JH, Bestwick JP, Channon S, Paradice R, Maina A, Rees R, Chiusano E, John R, Guaraldo V, George LM, Perona M, Dall'Amico D, Parkes AB, Joomun M, Wald NJ. Antenatal thyroid screening and childhood cognitive function. N Engl J Med. 2012 Feb 9;366(6):493-501. doi: 10.1056/NEJMoa1106104.
PubMed 22316443
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Thyroid Screening Protocol During Pregnancy: a Multi-center Prospective Controlled Study
- ClinicalTrials.gov ID
- NCT01838031
- Acronym / sponsor ID
- Z111107058811025
- Conditions
- Subclinical Hypothyroidism
- Keywords
- antenatal thyroid screening, subclinical hypothyroidism, thyroid function, thyroid antibody, pregnancy outcome, childhood cognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission
- Study start
- Sep 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 23 Apr 2013 (estimated)
- 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.
Estimate the proper thyroid screening method during pregnancy. Evaluate if maternal subclinical hypothyroidism treatment during pregnancy result in improved pregnancy outcome and cognitive function in the children.
Detailed description
The investigators conducted a single-blinded trial in which pregnant women at a gestation of less than 12 weeks, usually 6 to 8 weeks, provided blood samples for measurement of thyrotropin, free thyroxine(FT4) and thyroid peroxidase antibody (TPOAb). Women were assigned to a screening group in PUMCH (in which measurements were obtained immediately) or a control group in HMCHH (in which serum was stored and measurements were obtained shortly after delivery). Each group enrolled 1000 pregnant women separately. Women with positive findings in the screening group were given individualized levothyroxine treatment and regular follow-up. Compare the pregnancy outcomes, IQ at 2-3 years of age in children of women with subclinical hypothyroidism between two groups.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the control group | No intervention | –The serum will be stored and the measurements will be obtained after the delivery |
| the thyroid screening group | Active comparator | Other: thyroid screeningThe thyroid function and antibody will be measured during pregnancy. The subclinical hypothyroidism will be treated individually. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All of the pregnant women who receive prenatal care in PUMCH and HMCHH
- Sign the consent form
- agree to follow-up the pregnancy outcome and child
Key exclusion criteria (1 listed)
- the pregnant women who do not agree to enter the study
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 |
|---|---|---|
| thyroid screeningThe thyroid function and antibody will be measured immediately. The subclinical hypothyroidism will be treated individually. | Other | the thyroid screening group |
Primary outcome
Number of Participants with Adverse Events
Time frame: 1 year
the number of miscarriage，preeclampsia，gestational diabetes，prererm birth and postpartum hemorrhage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2013.
- Background: PubMed 21510801Bahn Chair RS, Burch HB, Cooper DS, Garber JR, Greenlee MC, Klein I, Laurberg P, McDougall IR, Montori VM, Rivkees SA, Ross DS, Sosa JA, Stan MN; American Thyroid Association; American Association of Clinical Endocrinologists. Hyperthyroidism and other causes of thyrotoxicosis: management guidelines of the American Thyroid Association and American Association of Clinical Endocrinologists. Thyroid. 2011 Jun;21(6):593-646. doi: 10.1089/thy.2010.0417. Epub 2011 Apr 21.
- Background: PubMed 22316443Lazarus JH, Bestwick JP, Channon S, Paradice R, Maina A, Rees R, Chiusano E, John R, Guaraldo V, George LM, Perona M, Dall'Amico D, Parkes AB, Joomun M, Wald NJ. Antenatal thyroid screening and childhood cognitive function. N Engl J Med. 2012 Feb 9;366(6):493-501. doi: 10.1056/NEJMoa1106104.
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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.
Liangkun Ma, MD study director
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thyroid screening in people with Subclinical Hypothyroidism, run by Peking Union Medical College Hospital at 1 site in China.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 26 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01838031, which also lists 2 linked publications.
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 26 Nov 2013.