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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01838031

Enrollment

1000

Registered

2013-04-23

Start date

2011-09-30

Completion date

2013-09-30

Last updated

2013-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subclinical Hypothyroidism

Keywords

antenatal thyroid screening, subclinical hypothyroidism, thyroid function, thyroid antibody, pregnancy outcome, childhood cognitive function

Brief 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.

Detailed 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.

Interventions

OTHERthyroid screening

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 42 Years

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

Design outcomes

Primary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026