Thyroid Screening Protocol During Pregnancy: a Multi-center Prospective Controlled Study
Randomized Thyroid Screening Protocol During Pregnancy: a Multi-center Prospective Controlled Study
1 other identifier
interventional
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 14, 2013
CompletedFirst Posted
Study publicly available on registry
April 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedNovember 26, 2013
November 1, 2013
2 years
April 14, 2013
November 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants with Adverse Events
the number of miscarriage，preeclampsia，gestational diabetes，prererm birth and postpartum hemorrhage
1 year
Study Arms (2)
the control group
NO INTERVENTIONThe serum will be stored and the measurements will be obtained after the delivery
the thyroid screening group
ACTIVE COMPARATORThe thyroid function and antibody will be measured during pregnancy. The subclinical hypothyroidism will be treated individually.
Interventions
The thyroid function and antibody will be measured immediately. The subclinical hypothyroidism will be treated individually.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- the pregnant women who do not agree to enter the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Related Publications (2)
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.
PMID: 21510801BACKGROUNDLazarus 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.
PMID: 22316443BACKGROUND
Study Officials
- STUDY DIRECTOR
Liangkun Ma, MD
Peking Union Medical College Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate profesoor
Study Record Dates
First Submitted
April 14, 2013
First Posted
April 23, 2013
Study Start
September 1, 2011
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
November 26, 2013
Record last verified: 2013-11