Preconceptional Thyroid Screening and Childhood Nerocognitive Function

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Fudan University
Sponsor:
Collaborators:
Shanghai Municipal Science and Technology Commission
Shanghai Municipal Health Bureau
Information provided by (Responsible Party):
Xiaotian Li, Fudan University
ClinicalTrials.gov Identifier:
NCT01744743
First received: October 20, 2012
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention
Hypothyroidism
Procedure: levothyroxine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preconceptional Thyroid Screening and Childhood Nerocognitive Function

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Offspring neurocognitive assessment at 0-3 yrs [ Time Frame: 3 months, 6 months, 1 year, 2 years, 3 years ] [ Designated as safety issue: No ]
    Peabody scale, Griffith scale

  • Offspring IQ assessment at 0-3 yrs [ Time Frame: 3 months, 6 months, 1 year, 2 years, 3 years ] [ Designated as safety issue: No ]
    Wechsler Preschool Intelligence Scale at 1, 2, 3-year-old


Secondary Outcome Measures:
  • Incidence of neonatal hypothyroid and complications [ Time Frame: up to 28 days of birth ] [ Designated as safety issue: No ]
    neonatal hypothyroid function, NICU rate, neonatal death rate


Other Outcome Measures:
  • Incidence of maternal complications [ Time Frame: up to 42 days postpartumn ] [ Designated as safety issue: No ]
    preeclampsia, GDM, maternal death rate, maternal hemorrhage rate


Estimated Enrollment: 600
Study Start Date: January 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
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.
Active Comparator: 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
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.
Placebo Comparator: 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
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.

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744743

Contacts
Contact: Xiaotian Li, MD, PhD 862163455050 xiaotianli555@163.com
Contact: Qiongjie Zhou, MD 862163455050 qj_zhou@163.com

Locations
China, Shanghai
Obstetrics and Gynecology Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200011
Contact: Xiaotian Li, MD, PhD    862163455050    xiaotianli555@163.com   
Contact: Qiongjie Zhou, MD    862163455050    qj_zhou@163.com   
Sponsors and Collaborators
Fudan University
Shanghai Municipal Science and Technology Commission
Shanghai Municipal Health Bureau
Investigators
Principal Investigator: Xiaotian Li, MD, PhD Obstetrics and Gynecology Hospital, Fudan University
  More Information

No publications provided

Responsible Party: Xiaotian Li, Vice president, Cheif of Obstetrics Department, Obstetrics and Gynecology Hospital, Fudan University
ClinicalTrials.gov Identifier: NCT01744743     History of Changes
Other Study ID Numbers: 12XD1401300
Study First Received: October 20, 2012
Last Updated: December 7, 2012
Health Authority: China: Science and Technology Commission of Shanghai Municipality

Keywords provided by Fudan University:
preconception
hypothyroidism
neurocognitive development

Additional relevant MeSH terms:
Hypothyroidism
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014