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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Completed

Conditions: Subclinical Hypothyroidism

Treatments: Other: thyroid screening

Study type: Interventional

Funder types: Other

Identifiers

NCT01838031

Z111107058811025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 2 patient groups

the control group

No Intervention group

Description:

The serum will be stored and the measurements will be obtained after the delivery

the thyroid screening group

Active Comparator group

Description:

The thyroid function and antibody will be measured during pregnancy. The subclinical hypothyroidism will be treated individually.

Treatment:

Other: thyroid screening