Preconceptional Thyroid Screening and Childhood Nerocognitive Function

NCT01744743 | Unknown DMC

• 1 other identifier: 12XD1401300
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypothyroidism

Keywords

preconception; hypothyroidism; neurocognitive development

Outcome Measures

Primary Outcomes (2)

• Offspring neurocognitive assessment at 0-3 yrs

  Peabody scale, Griffith scale

  3 months, 6 months, 1 year, 2 years, 3 years

• 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 Outcomes (1)

• Incidence of neonatal hypothyroid and complications

  up to 28 days of birth

Other Outcomes (1)

• Incidence of maternal complications

  up to 42 days postpartumn

Study Arms (3)

preconception

ACTIVE COMPARATOR

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

early conception

ACTIVE COMPARATOR

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

late conception

PLACEBO COMPARATOR

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

Interventions

levothyroxine PROCEDURE

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

early conception; late conception; preconception

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• age: less than 18 or more than 55
• multiple pregnancy
• thyroid tumor disease history
• those who cannot obey the rules of this study

Sponsors & Collaborators

• Fudan University: lead
• Shanghai Municipal Science and Technology Commission: collaborator
• Shanghai Municipal Health Bureau: collaborator

Study Sites (1)

Obstetrics and Gynecology Hospital, Fudan University

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

Related Publications (2)

• Zhao Z, Zhou Q, Zhao H, Xiong Y, Li X. Association between levothyroxine treatment for maternal subclinical hypothyroidism with negative TPOAb and early child neurodevelopment: A prospective real-world clinical trial. Acta Obstet Gynecol Scand. 2023 Sep;102(9):1183-1192. doi: 10.1111/aogs.14602. Epub 2023 Jul 13.

  PMID: 37443452 DERIVED

• Zhou Q, Wang C, Xu H, Li X. Impact of Preconception Treatment Initiation for Hypothyroidism on Neurocognitive Function in Children. J Clin Endocrinol Metab. 2020 Nov 1;105(11):dgaa565. doi: 10.1210/clinem/dgaa565.

  PMID: 32841335 DERIVED

MeSH Terms

Conditions

Hypothyroidism

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Xiaotian Li, MD, PhD

  Obstetrics and Gynecology Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaotian Li, MD, PhD

CONTACT

862163455050; xiaotianli555@163.com

Qiongjie Zhou, MD

CONTACT

862163455050; qj_zhou@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president, Cheif of Obstetrics Department, Obstetrics and Gynecology Hospital

Study Record Dates

• First Submitted: October 20, 2012
• First Posted: December 7, 2012
• Study Start: January 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: December 11, 2012

Record last verified: 2012-12

Locations

CN (1)