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

Not Applicable

Completed

• Conditions: Subclinical Hypothyroidism
• Interventions: Other: thyroid screening

• Registration Number: NCT01838031
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2013-04-14
• Study First Submitted QC: 2013-04-18
• Study First Posted: 2013-04-23
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-25
• Last Update Posted: 2013-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the thyroid screening group	thyroid screening	The thyroid function and antibody will be measured during pregnancy. The subclinical hypothyroidism will be treated individually.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China