HypothyroidismNCT01744743
Preconceptional Thyroid Screening and Childhood Nerocognitive Function
A study testing levothyroxine in people with Hypothyroidism, run by Fudan University at 1 site in China.
Trial summary
To assess the effect of universal preconception hypothyroidism for maternal pregnancy outcome, and 0-3yrs offspring neurocognitive ability and IQ score. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- levothyroxine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Dec 2015
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Preconceptional group：TSH ≥ 97.5%th and/or FT4 ≤ 2.5%th
- age: 18-55
- those who can obey the rules of this study and assign the consent
Who cannot join
- age: less than 18 or more than 55
- multiple pregnancy
- thyroid tumor disease history
- those who cannot obey the rules of this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Obstetrics and Gynecology Hospital, Fudan University
Shanghai, Shanghai Municipality, 200011
Xiaotian Li, MD, PhD, 862163455050, xiaotianli555@163.com
Qiongjie Zhou, MD, 862163455050, qj_zhou@163.com
About this study
To assess the effect of universal preconception hypothyroidism for maternal pregnancy outcome, and 0-3yrs offspring neurocognitive ability and IQ score.
Read the detailed description
Epidemic evidence and animal studies suggested that hypothyroidism is related with maternal pregnancy outcome, offspring cognitive ability. Negro's study found improved maternal health in those screened in early trimester; while Lazarus et al. reported no significant offspring IQ score at 3yrs in universal screening in early trimester. Currently, it lacks evidence of universal pre-conception screening for maternal pregnancy outcome and offspring cognitive development, motivation ability, attention. China Governmental Health Department has included thyroid function screening into preconception in 2011. The investigators hypothesize that pre-conception effective treatment may be helpful for decrease possible negative effects on maternal and offspring health, instead of early trimester.
- Conditions
- Hypothyroidism
- Being tested
- levothyroxine
- Keywords
- preconception, hypothyroidism, neurocognitive development
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levothyroxineProcedure or surgery
Women with TSH≥97.5%th and/or FT4≤2.5%th will accept levothyroxine 150ug daily and follow-up every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| preconception | Active comparator | Participants will be included according to their first outpatient visiting time. Women with TSH≥97.5%th and/or FT4≤2.5%th will accept levothyroxine 150ug daily and follow-up every 4 weeks. Medical records include: a)maternal thyroid function at enrollment; b) Levothyroxine: length, dose, drug adverse effects; c)Early trimester of pregnancy: Down's screening; d)2nd trimester of pregnancy: fetal echocardiography; e)Whole course of pregnancy: maternal complications, maternal blood pressure at each visit, fetal growth; f)Pregnancy outcome: type of delivery, length of labor, type and timing of analgesia/anesthesia, Apgar scores, postpartum hemorrhage, fetal complications; g)Offspring cognitive assessment at 0-3 years old Receives: Procedure: levothyroxine |
| early conception | Active comparator | Participants will be included according to their first outpatient visiting time before 15+6 gestational week. Women with TSH≥97.5%th and/or FT4≤2.5%th will accept levothyroxine 150ug daily and follow-up every 4 weeks. Medical records include: a)maternal thyroid function at enrollment; b) Levothyroxine: length, dose, drug adverse effects; c)Early trimester of pregnancy: Down's screening; d)2nd trimester of pregnancy: fetal echocardiography; e)Whole course of pregnancy: maternal complications, maternal blood pressure at each visit, fetal growth; f)Pregnancy outcome: type of delivery, length of labor, type and timing of analgesia/anesthesia, Apgar scores, postpartum hemorrhage, fetal complications; g)Offspring cognitive assessment at 0-3 years old Receives: Procedure: levothyroxine |
| late conception | Placebo comparator | Participants will be included according to their first outpatient visiting time after 16 gestational week. Women with TSH≥97.5%th and/or FT4≤2.5%th will accept levothyroxine 150ug daily and follow-up every 4 weeks. Medical records include: a)maternal thyroid function at enrollment; b) Levothyroxine: length, dose, drug adverse effects; c)Early trimester of pregnancy: Down's screening; d)2nd trimester of pregnancy: fetal echocardiography; e)Whole course of pregnancy: maternal complications, maternal blood pressure at each visit, fetal growth; f)Pregnancy outcome: type of delivery, length of labor, type and timing of analgesia/anesthesia, Apgar scores, postpartum hemorrhage, fetal complications; g)Offspring cognitive assessment at 0-3 years old Receives: Procedure: levothyroxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Offspring neurocognitive assessment at 0-3 yrs
Peabody scale, Griffith scale
Measured: 3 months, 6 months, 1 year, 2 years, 3 years
Offspring IQ assessment at 0-3 yrs
Wechsler Preschool Intelligence Scale at 1, 2, 3-year-old
Measured: 3 months, 6 months, 1 year, 2 years, 3 years
Secondary outcomes (1)
Incidence of neonatal hypothyroid and complications
neonatal hypothyroid function, NICU rate, neonatal death rate
Measured: up to 28 days of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2012 (estimated)
- Study startJan 2011
- Primary completionDec 2014 (estimated)
- Study completionDec 2015 (estimated)
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 HypothyroidismStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Municipal Science and Technology Commission, Shanghai Municipal Health Bureau
- Responsible party
- Principal investigator, Xiaotian Li, Fudan University
- Investigators
- Xiaotian Li, MD, PhD, Principal investigator, Obstetrics and Gynecology Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744743
- Sponsor's protocol ID
- 12XD1401300
- Status last verified
- Dec 2012
- First submitted
- 20 Oct 2012
- Last updated
- 11 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhao Z, Zhou Q, Zhao H, Xiong Y, Li X. Association between levothyroxine treatment for maternal subclinical hypothyroidism with negative TPOAb and early child neurodevelopment: A prospective real-world clinical trial. Acta Obstet Gynecol Scand. 2023 Sep;102(9):1183-1192. doi: 10.1111/aogs.14602. Epub 2023 Jul 13.
PubMed 37443452Zhou Q, Wang C, Xu H, Li X. Impact of Preconception Treatment Initiation for Hypothyroidism on Neurocognitive Function in Children. J Clin Endocrinol Metab. 2020 Nov 1;105(11):dgaa565. doi: 10.1210/clinem/dgaa565.
PubMed 32841335
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preconceptional Thyroid Screening and Childhood Nerocognitive Function
- ClinicalTrials.gov ID
- NCT01744743
- Acronym / sponsor ID
- 12XD1401300
- Conditions
- Hypothyroidism
- Keywords
- preconception, hypothyroidism, neurocognitive development
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Municipal Science and Technology Commission, Shanghai Municipal Health Bureau
- Study start
- Jan 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 7 Dec 2012 (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.
To assess the effect of universal preconception hypothyroidism for maternal pregnancy outcome, and 0-3yrs offspring neurocognitive ability and IQ score.
Detailed description
Epidemic evidence and animal studies suggested that hypothyroidism is related with maternal pregnancy outcome, offspring cognitive ability. Negro's study found improved maternal health in those screened in early trimester; while Lazarus et al. reported no significant offspring IQ score at 3yrs in universal screening in early trimester. Currently, it lacks evidence of universal pre-conception screening for maternal pregnancy outcome and offspring cognitive development, motivation ability, attention. China Governmental Health Department has included thyroid function screening into preconception in 2011. The investigators hypothesize that pre-conception effective treatment may be helpful for decrease possible negative effects on maternal and offspring health, instead of early trimester.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| preconception | Active comparator | Procedure: levothyroxineParticipants will be included according to their first outpatient visiting time. Women with TSH≥97.5%th and/or FT4≤2.5%th will accept levothyroxine 150ug daily and follow-up every 4 weeks. Medical records include: a)maternal thyroid function at enrollment; b) Levothyroxine: length, dose, drug adverse effects; c)Early trimester of pregnancy: Down's screening; d)2nd trimester of pregnancy: fetal echocardiography; e)Whole course of pregnancy: maternal complications, maternal blood pressure at each visit, fetal growth; f)Pregnancy outcome: type of delivery, length of labor, type and timing of analgesia/anesthesia, Apgar scores, postpartum hemorrhage, fetal complications; g)Offspring cognitive assessment at 0-3 years old |
| early conception | Active comparator | Procedure: levothyroxineParticipants will be included according to their first outpatient visiting time before 15+6 gestational week. Women with TSH≥97.5%th and/or FT4≤2.5%th will accept levothyroxine 150ug daily and follow-up every 4 weeks. Medical records include: a)maternal thyroid function at enrollment; b) Levothyroxine: length, dose, drug adverse effects; c)Early trimester of pregnancy: Down's screening; d)2nd trimester of pregnancy: fetal echocardiography; e)Whole course of pregnancy: maternal complications, maternal blood pressure at each visit, fetal growth; f)Pregnancy outcome: type of delivery, length of labor, type and timing of analgesia/anesthesia, Apgar scores, postpartum hemorrhage, fetal complications; g)Offspring cognitive assessment at 0-3 years old |
| late conception | Placebo comparator | Procedure: levothyroxineParticipants will be included according to their first outpatient visiting time after 16 gestational week. Women with TSH≥97.5%th and/or FT4≤2.5%th will accept levothyroxine 150ug daily and follow-up every 4 weeks. Medical records include: a)maternal thyroid function at enrollment; b) Levothyroxine: length, dose, drug adverse effects; c)Early trimester of pregnancy: Down's screening; d)2nd trimester of pregnancy: fetal echocardiography; e)Whole course of pregnancy: maternal complications, maternal blood pressure at each visit, fetal growth; f)Pregnancy outcome: type of delivery, length of labor, type and timing of analgesia/anesthesia, Apgar scores, postpartum hemorrhage, fetal complications; g)Offspring cognitive assessment at 0-3 years old |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Preconceptional group：TSH ≥ 97.5%th and/or FT4 ≤ 2.5%th
- age: 18-55
- those who can obey the rules of this study and assign the consent
Key exclusion criteria (4 listed)
- age: less than 18 or more than 55
- multiple pregnancy
- thyroid tumor disease history
- those who cannot obey the rules of this 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 |
|---|---|---|
| levothyroxineWomen with TSH≥97.5%th and/or FT4≤2.5%th will accept levothyroxine 150ug daily and follow-up every 4 weeks. | Procedure or surgery | early conception, late conception, preconception |
Primary outcome
Offspring neurocognitive assessment at 0-3 yrs
Time frame: 3 months, 6 months, 1 year, 2 years, 3 years
Peabody scale, Griffith scale
Offspring IQ assessment at 0-3 yrs
Time frame: 3 months, 6 months, 1 year, 2 years, 3 years
Wechsler Preschool Intelligence Scale at 1, 2, 3-year-old
1 secondary outcome
Incidence of neonatal hypothyroid and complications
Time frame: up to 28 days of birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2012.
- Derived from this study: PubMed 37443452Zhao Z, Zhou Q, Zhao H, Xiong Y, Li X. Association between levothyroxine treatment for maternal subclinical hypothyroidism with negative TPOAb and early child neurodevelopment: A prospective real-world clinical trial. Acta Obstet Gynecol Scand. 2023 Sep;102(9):1183-1192. doi: 10.1111/aogs.14602. Epub 2023 Jul 13.
- Derived from this study: PubMed 32841335Zhou Q, Wang C, Xu H, Li X. Impact of Preconception Treatment Initiation for Hypothyroidism on Neurocognitive Function in Children. J Clin Endocrinol Metab. 2020 Nov 1;105(11):dgaa565. doi: 10.1210/clinem/dgaa565.
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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.
Xiaotian Li, MD, PhD principal investigator
Obstetrics and Gynecology Hospital, Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing levothyroxine in people with Hypothyroidism, run by Fudan University 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 4 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 11 Dec 2012. 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. Some participants in this study may receive a placebo. 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 Xiaotian Li, MD, PhD (862163455050, xiaotianli555@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Offspring neurocognitive assessment at 0-3 yrs (time frame: 3 months, 6 months, 1 year, 2 years, 3 years). The study lists 2 primary outcomes in all. 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 NCT01744743, 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 11 Dec 2012.