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Preconceptional Thyroid Screening and Childhood Nerocognitive Function

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ClinicalTrials.gov Identifier: NCT01744743
Recruitment Status : Unknown
Verified December 2012 by Xiaotian Li, Fudan University.
Recruitment status was:  Recruiting
First Posted : December 7, 2012
Last Update Posted : December 11, 2012
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Hypothyroidism Procedure: levothyroxine

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preconceptional Thyroid Screening and Childhood Nerocognitive Function
Study Start Date : January 2011
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Offspring neurocognitive assessment at 0-3 yrs [ Time Frame: 3 months, 6 months, 1 year, 2 years, 3 years ]
    Peabody scale, Griffith scale

  2. 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


Secondary Outcome Measures :
  1. Incidence of neonatal hypothyroid and complications [ Time Frame: up to 28 days of birth ]
    neonatal hypothyroid function, NICU rate, neonatal death rate


Other Outcome Measures:
  1. Incidence of maternal complications [ Time Frame: up to 42 days postpartumn ]
    preeclampsia, GDM, maternal death rate, maternal hemorrhage rate


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 7, 2012    Key Record Dates
Last Update Posted: December 11, 2012
Last Verified: December 2012

Keywords provided by Xiaotian Li, Fudan University:
preconception
hypothyroidism
neurocognitive development

Additional relevant MeSH terms:
Hypothyroidism
Thyroid Diseases
Endocrine System Diseases