Thyroid Screening Protocol During Pregnancy: a Multi-center Prospective Controlled Study

Subclinical Hypothyroidism Clinical Trial

Official title:

Randomized Thyroid Screening Protocol During Pregnancy: a Multi-center Prospective Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01838031
• Other study ID #: Z111107058811025
• Status: Completed
• Phase: N/A
• First received: April 14, 2013
• Last updated: November 25, 2013
• Start date: September 2011
• Est. completion date: September 2013

Study information

• Verified date: November 2013
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Estimate the proper thyroid screening method during pregnancy. Evaluate if maternal subclinical hypothyroidism treatment during pregnancy result in improved pregnancy outcome and cognitive function in the children.

Description:

The investigators conducted a single-blinded trial in which pregnant women at a gestation of less than 12 weeks, usually 6 to 8 weeks, provided blood samples for measurement of thyrotropin, free thyroxine(FT4) and thyroid peroxidase antibody (TPOAb). Women were assigned to a screening group in PUMCH (in which measurements were obtained immediately) or a control group in HMCHH (in which serum was stored and measurements were obtained shortly after delivery). Each group enrolled 1000 pregnant women separately. Women with positive findings in the screening group were given individualized levothyroxine treatment and regular follow-up. Compare the pregnancy outcomes, IQ at 2-3 years of age in children of women with subclinical hypothyroidism between two groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

Inclusion Criteria:

• All of the pregnant women who receive prenatal care in PUMCH and HMCHH

• Sign the consent form

• agree to follow-up the pregnancy outcome and child

Exclusion Criteria:

• the pregnant women who do not agree to enter the study

Related Conditions & MeSH terms

• Hypothyroidism
• Subclinical Hypothyroidism
• Thyroid Diseases

Intervention

Other:
• thyroid screening
The thyroid function and antibody will be measured immediately. The subclinical hypothyroidism will be treated individually.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Beijing Municipal Science & Technology Commission

Country where clinical trial is conducted

China, 

References & Publications (2)

Bahn Chair RS, Burch HB, Cooper DS, Garber JR, Greenlee MC, Klein I, Laurberg P, McDougall IR, Montori VM, Rivkees SA, Ross DS, Sosa JA, Stan MN; American Thyroid Association; American Association of Clinical Endocrinologists. Hyperthyroidism and other causes of thyrotoxicosis: management guidelines of the American Thyroid Association and American Association of Clinical Endocrinologists. Thyroid. 2011 Jun;21(6):593-646. doi: 10.1089/thy.2010.0417. Epub 2011 Apr 21. Erratum in: Thyroid. 2011 Oct;21(10):1169. Thyroid. 2012 Nov;22(11):1195. — View Citation

Lazarus JH, Bestwick JP, Channon S, Paradice R, Maina A, Rees R, Chiusano E, John R, Guaraldo V, George LM, Perona M, Dall'Amico D, Parkes AB, Joomun M, Wald NJ. Antenatal thyroid screening and childhood cognitive function. N Engl J Med. 2012 Feb 9;366(6):493-501. doi: 10.1056/NEJMoa1106104. Erratum in: N Engl J Med. 2012 Apr 26;366(17):1650. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events	the number of miscarriage,preeclampsia,gestational diabetes,prererm birth and postpartum hemorrhage	1 year