Preconceptional Thyroid Screening and Childhood Nerocognitive Function

Hypothyroidism Clinical Trial

Official title:

Preconceptional Thyroid Screening and Childhood Nerocognitive Function

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01744743
• Other study ID #: 12XD1401300
• Status: Unknown status
• Phase: N/A
• First received: October 20, 2012
• Last updated: December 7, 2012
• Start date: January 2011
• Est. completion date: December 2015

Study information

• Verified date: December 2012
• Source: Fudan University
• Contact: Xiaotian Li, MD, PhD
• Phone: 862163455050
• Email: xiaotianli555[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 600
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypothyroidism

Intervention

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

Locations

Country	Name	City	State
China	Obstetrics and Gynecology Hospital, Fudan University	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Fudan University	Shanghai Municipal Health Bureau, Shanghai Municipal Science and Technology Commission

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of maternal complications	preeclampsia, GDM, maternal death rate, maternal hemorrhage rate	up to 42 days postpartumn
Primary	Offspring neurocognitive assessment at 0-3 yrs	Peabody scale, Griffith scale	3 months, 6 months, 1 year, 2 years, 3 years
Primary	Offspring IQ assessment at 0-3 yrs	Wechsler Preschool Intelligence Scale at 1, 2, 3-year-old	3 months, 6 months, 1 year, 2 years, 3 years
Secondary	Incidence of neonatal hypothyroid and complications	neonatal hypothyroid function, NICU rate, neonatal death rate	up to 28 days of birth