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Preconceptional Thyroid Screening and Childhood Nerocognitive Function

Information source: Fudan University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypothyroidism

Intervention: levothyroxine (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Fudan University

Official(s) and/or principal investigator(s):
Xiaotian Li, MD, PhD, Principal Investigator, Affiliation: Obstetrics and Gynecology Hospital, Fudan University

Overall contact:
Xiaotian Li, MD, PhD, Phone: 862163455050, Email: xiaotianli555@163.com

Summary

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

Clinical Details

Official title: Preconceptional Thyroid Screening and Childhood Nerocognitive Function

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Primary outcome:

Offspring neurocognitive assessment at 0-3 yrs

Offspring IQ assessment at 0-3 yrs

Secondary outcome: Incidence of neonatal hypothyroid and complications

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.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Xiaotian Li, MD, PhD, Phone: 862163455050, Email: xiaotianli555@163.com

Obstetrics and Gynecology Hospital, Fudan University, Shanghai, Shanghai 200011, China; Recruiting
Xiaotian Li, MD, PhD, Phone: 862163455050, Email: xiaotianli555@163.com
Qiongjie Zhou, MD, Phone: 862163455050, Email: qj_zhou@163.com
Additional Information

Starting date: January 2011
Last updated: December 7, 2012

Page last updated: August 23, 2015

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