Preconceptional Thyroid Screening and Childhood Nerocognitive Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-12-31

Brief Summary

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To assess the effect of universal preconception hypothyroidism for maternal pregnancy outcome, and 0-3yrs offspring neurocognitive ability and IQ score.

Detailed Description

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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

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Hypothyroidism

Keywords

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preconception hypothyroidism neurocognitive development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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preconception

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

Group Type ACTIVE_COMPARATOR

levothyroxine

Intervention Type PROCEDURE

Women with TSH≥97.5%th and/or FT4≤2.5%th will accept levothyroxine 150ug daily and follow-up every 4 weeks.

early conception

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

Group Type ACTIVE_COMPARATOR

levothyroxine

Intervention Type PROCEDURE

Women with TSH≥97.5%th and/or FT4≤2.5%th will accept levothyroxine 150ug daily and follow-up every 4 weeks.

late conception

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

Group Type PLACEBO_COMPARATOR

levothyroxine

Intervention Type PROCEDURE

Women with TSH≥97.5%th and/or FT4≤2.5%th will accept levothyroxine 150ug daily and follow-up every 4 weeks.

Interventions

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levothyroxine

Women with TSH≥97.5%th and/or FT4≤2.5%th will accept levothyroxine 150ug daily and follow-up every 4 weeks.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Preconceptional group：TSH ≥ 97.5%th and/or FT4 ≤ 2.5%th
2. age: 18-55
3. those who can obey the rules of this study and assign the consent

Exclusion Criteria

1. age: less than 18 or more than 55
2. multiple pregnancy
3. thyroid tumor disease history
4. those who cannot obey the rules of this study

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Xiaotian Li

Vice president, Cheif of Obstetrics Department, Obstetrics and Gynecology Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaotian Li, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Obstetrics and Gynecology Hospital, Fudan University

Locations

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Obstetrics and Gynecology Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaotian Li, MD, PhD

Role: CONTACT

Phone: 862163455050

Email: [email protected]

Qiongjie Zhou, MD

Role: CONTACT

Phone: 862163455050

Email: [email protected]

Facility Contacts

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Xiaotian Li, MD, PhD

Role: primary

Qiongjie Zhou, MD

Role: backup

References

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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.

Reference Type DERIVED

PMID: 37443452 (View on PubMed)

Zhou 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.

Reference Type DERIVED

PMID: 32841335 (View on PubMed)

Other Identifiers

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12XD1401300

Identifier Type: -

Identifier Source: org_study_id

Preconceptional Thyroid Screening and Childhood Nerocognitive Function

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

preconception

levothyroxine

early conception

levothyroxine

late conception

levothyroxine

Interventions

levothyroxine

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Shanghai Municipal Science and Technology Commission

Shanghai Municipal Health Bureau

Fudan University

Responsible Party

Xiaotian Li

Principal Investigators

Xiaotian Li, MD, PhD

Locations

Obstetrics and Gynecology Hospital, Fudan University

Countries

Central Contacts

Xiaotian Li, MD, PhD

Qiongjie Zhou, MD

Facility Contacts

Xiaotian Li, MD, PhD

Qiongjie Zhou, MD

References

Zhou 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.

Other Identifiers

12XD1401300