Maternal Autoimmune Thyroid Disease and Fetal Thyroxin
Fetal Thyroid Hormones Concentration In Hyperthyroid or Hypothyroid Pregnant Women
1 other identifier
observational
83
1 country
1
Brief Summary
The purpose of this trial is to correlate fetal thyroid hormones from fetal cord blood with clinical (maternal antithyroid drug dose and antithyroid antibodies) and ultrasound (US) parameters of fetal thyroid function from pregnant mothers with autoimmune thyroid disease (AITD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2001
Longer than P75 for all trials
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
January 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 12, 2012
CompletedFirst Posted
Study publicly available on registry
February 8, 2012
CompletedFebruary 8, 2012
February 1, 2012
10.2 years
January 12, 2012
February 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fetal free thyroxin
24th to 32nd week of gestation
Secondary Outcomes (3)
fetal ultrasound parameters
24th to 32nd week of gestation
maternal antithyroid antibodies
24th to 32nd week of gestation
dose of maternal antithyroid medication (ATD)
24th to 32nd week of gestation
Study Arms (3)
Hyperthyroid pregnant women
hyperthyroidism diagnosed and treated by an endocrinologist, based on clinical and laboratory tests and ultrasound thyroid examination.
Hypothyroid pregnant women
hypothyroidism diagnosed and treated by an endocrinologist, based on clinical and laboratory tests and ultrasound thyroid examination
Healthy pregnant women
uncomplicated pregnancies in healthy women, older then 35 years, directed for cordocentesis due to age, because of missed karyotyping in previous period of pregnancy
Eligibility Criteria
Groups are selected from State tertiary referral centre for Gynecology and Obstetrics
You may qualify if:
- Autoimmune hyper or hypothyroidism, diagnosed by an endocrinologist, treated, based on clinical and laboratory tests and ultrasound thyroid examination.
- Patients were included if they were seen by gynecologist at Clinic for Gynecology up until 20th week of gestation and not later.
- healthy pregnant women in control group were directed for cordocentesis due to age.
You may not qualify if:
- Any other chronic diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinic for Gynecology and Obstetrics
Belgrade, Serbia, 11000, Serbia
Related Publications (1)
Abalovich M, Amino N, Barbour LA, Cobin RH, De Groot LJ, Glinoer D, Mandel SJ, Stagnaro-Green A. Management of thyroid dysfunction during pregnancy and postpartum: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2007 Aug;92(8 Suppl):S1-47. doi: 10.1210/jc.2007-0141.
PMID: 17948378BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Svetlana Spremovic-Radjenovic, MD PhD
Medical School of the University of Belgrade
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor, gynecologist and obstetrician, subspecialist in endocrinology
Study Record Dates
First Submitted
January 12, 2012
First Posted
February 8, 2012
Study Start
January 1, 2001
Primary Completion
March 1, 2011
Study Completion
June 1, 2011
Last Updated
February 8, 2012
Record last verified: 2012-02