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

NCT ID: NCT01838031

Last Updated: 2013-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-09-30

Brief Summary

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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

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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.

Conditions

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Subclinical Hypothyroidism

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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the control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

the thyroid screening group

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

Group Type ACTIVE_COMPARATOR

thyroid screening

Intervention Type OTHER

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

Interventions

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thyroid screening

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Beijing Municipal Science & Technology Commission

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Liangkun Ma

associate profesoor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liangkun Ma, MD

Role: STUDY_DIRECTOR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 21510801 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22316443 (View on PubMed)

Other Identifiers

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Z111107058811025

Identifier Type: -

Identifier Source: org_study_id