Back to resultsThyroid Screening Protocol During Pregnancy: a Multi-center Prospective Controlled Study
Primary Purpose
Subclinical Hypothyroidism
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
thyroid screening
Sponsored by
About this trial
This is an interventional screening trial for Subclinical Hypothyroidism focused on measuring antenatal thyroid screening, subclinical hypothyroidism, thyroid function, thyroid antibody, pregnancy outcome, childhood cognitive function
Eligibility Criteria
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
Sites / Locations
- Peking Union Medical College Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
the control group
the thyroid screening group
Arm Description
The serum will be stored and the measurements will be obtained after the delivery
The thyroid function and antibody will be measured during pregnancy. The subclinical hypothyroidism will be treated individually.
Outcomes
Primary Outcome Measures
Number of Participants with Adverse Events
the number of miscarriage，preeclampsia，gestational diabetes，prererm birth and postpartum hemorrhage
Secondary Outcome Measures
Full Information
NCT ID
NCT01838031
First Posted
April 14, 2013
Last Updated
November 25, 2013
Sponsor
Peking Union Medical College Hospital
Collaborators
Beijing Municipal Science & Technology Commission
1. Study Identification
Unique Protocol Identification Number
NCT01838031
Brief Title
Thyroid Screening Protocol During Pregnancy: a Multi-center Prospective Controlled Study
Official Title
Randomized Thyroid Screening Protocol During Pregnancy: a Multi-center Prospective Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
Beijing Municipal Science & Technology Commission
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subclinical Hypothyroidism
Keywords
antenatal thyroid screening, subclinical hypothyroidism, thyroid function, thyroid antibody, pregnancy outcome, childhood cognitive function
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
the control group
Arm Type
No Intervention
Arm Description
The serum will be stored and the measurements will be obtained after the delivery
Arm Title
the thyroid screening group
Arm Type
Active Comparator
Arm Description
The thyroid function and antibody will be measured during pregnancy. The subclinical hypothyroidism will be treated individually.
Intervention Type
Other
Intervention Name(s)
thyroid screening
Intervention Description
The thyroid function and antibody will be measured immediately. The subclinical hypothyroidism will be treated individually.
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events
Description
the number of miscarriage，preeclampsia，gestational diabetes，prererm birth and postpartum hemorrhage
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liangkun Ma, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
21510801
Citation
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. Erratum In: Thyroid. 2011 Oct;21(10):1169. Thyroid. 2012 Nov;22(11):1195.
Results Reference
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PubMed Identifier
22316443
Citation
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. Erratum In: N Engl J Med. 2012 Apr 26;366(17):1650.
Results Reference
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Thyroid Screening Protocol During Pregnancy: a Multi-center Prospective Controlled Study
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