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Completed

NCT Number: NCT01838031

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

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.

Completed

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Key information

Conditions

Subclinical Hypothyroidism

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

thyroid screening

Other

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

Primary outcomes

  1. Number of Participants with Adverse Events

    Time frame: 1 year

    the number of miscarriage，preeclampsia，gestational diabetes，prererm birth and postpartum hemorrhage

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • Beijing Municipal Science & Technology Commission

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 23, 2013
Registry last updated
Nov 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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