Status:
COMPLETED
Selenium Supplementation in Pregnancy
Lead Sponsor:
University of Roma La Sapienza
Conditions:
Pregnancy
Infertility
Eligibility:
FEMALE
18-38 years
Phase:
NA
Brief Summary
Serum levels of isolated anti-thyroperoxidase (TPOab) and anti-thyreoglobulin (Tgab) autoantibodies are strongly associated with an increased risk of miscarriage and premature deliveries in euthyroid ...
Detailed Description
Adverse outcomes, postpartum thyroid dysfunction and permanent hypothyroidism have been associated with isolated TPOab positivity in euthyroid pregnant women. In areas with severe selenium deficiency...
Eligibility Criteria
Inclusion
- pregnant women with 10°± 2 weeks of gestation
- women in whom embryo transfer is expected within 60 days
- euthyroid women (0.4 μIU/ml \< TSH \< 2.5 μIU/ml), positive for TPOab and/or TgAb, not assuming LT4 replacement
- euthyroid women (0.4 μIU/ml \< TSH \< 2.5 μIU/ml), positive for TPOab and/or TgAb under LT4 replacement (to maintain TSH within the control range).
- women with TSH \> 2.5 μIU/ml positive for TPOab and/or TgAb, not assuming LT4 replacement (requiring the beginning of LT4 replacement)
- women with TSH \> 2.5 μIU/ml positive for TPOab and/or TgAb, under LT4 replacement (requiring an adjustment of LT4 replacement)
Exclusion
- use of dietary supplements containing selenium in the previous 4 months;
- use of antidepressive/psychotic drugs, amiodarone, propanolol, lithium, cytokines;
- history of hyperthyroidism positive anti-thyrotropin ab;
- previous partial or total thyroidectomy;
- known fetal anomaly;
- known infections (PID, HIV, HCV) and mola hydatidoses;
- chronic renal failure;
- uncontrolled hypertension;
- uterine malformation;
- history of medical and metabolic complication such as heart disease or diabetes;
- previous embryo transfer failed within last 3 months;
- miscarriage within last 3 months;
- gestational diabetes in previous pregnancies.
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01465867
Start Date
April 1 2012
End Date
January 1 2018
Last Update
January 30 2018
Active Locations (11)
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1
Azienda ospedaliero-universitaria Careggi
Florence, Italy, 50134
2
Istituto Auxologico Italiano
Milan, Italy, 20095
3
Ospedale Maggiore Policlinico
Milan, Italy, 20122
4
University Federico II
Naples, Italy, 80131