Preconceptional Thyroid Screening and Childhood Nerocognitive Function
This study is currently recruiting participants.
Verified December 2012 by Fudan University
Sponsor:
Fudan University
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
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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:
- Preconceptional group：TSH ≥ 97.5%th and/or FT4 ≤ 2.5%th
- age: 18-55
- those who can obey the rules of this study and assign the consent
Exclusion Criteria:
- age: less than 18 or more than 55
- multiple pregnancy
- thyroid tumor disease history
- those who cannot obey the rules of this study
Contacts and Locations
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 May 19, 2013