Randomized Thyroid Screening Protocol During Pregnancy: a Multi-center Prospective Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Number of Participants with Adverse Events
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 42 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
the control group
The serum will be stored and the measurements will be obtained after the delivery
the thyroid screening group
The thyroid function and antibody will be measured during pregnancy. The subclinical hypothyroidism will be treated individually.
Intervention: thyroid screening (Other)
Outcomes
Primary Outcomes
Number of Participants with Adverse Events
Time Frame: 1 year
the number of miscarriage，preeclampsia，gestational diabetes，prererm birth and postpartum hemorrhage
Secondary Outcomes
No secondary outcomes reported
Investigators
Liangkun Ma
associate profesoor
Peking Union Medical College Hospital