Hypothyroidism in Pregnancy Clinical Trial
Official title:
Fetal Thyroid Hormones Concentration In Hyperthyroid or Hypothyroid Pregnant Women
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).
Maternal hyperthyroidism in pregnancy is complicated with hypertension, preeclampsia, heart
failure, thyroid storm, preterm labor and stillbirth, while the fetus suffers from
intrauterine growth retardation (IUGR), goiter; neonatal prematurity and low birth weight.
Maternal hypothyroidism is seen in 2 % of pregnancies. Risks are higher for preeclampsia,
postpartum hemorrhage, miscarriage, stillbirth, preterm birth and lower IQ score.
Thyroid stimulating hormone (TSH) receptor antibodies, antithyroid drugs and iodine pass to
the fetus. So the fetus may also become a patient. Monitoring fetal growth, fetal heart rate
(tachycardia is a late sign of fetal hyperthyroidism), bone maturation and the size of the
fetal thyroid by ultrasound are important parameters for the assessment of transfer of
hyperthyroidism from mother to the fetus
Patients follow up:
After inclusion into the study, thyroid function tests (fT4, TSH), and auto-antibodies
assessment (anti TPO, TRAK) were performed once every two months in mothers with AITD, and
from the 24th week of gestation monthly. Treatment was adjusted accordingly. Ultrasound for
fetal size, morphology and fetal heart rate (FHR) was performed once in two months, and from
the 24th week of gestation, monthly. The fetal biophysical profile score was determined
weekly from the 30th week of gestation. The single centre design was chosen: all fetal
sonograms were performed by the same gynecologist. Cardiotocography was performed once
weekly from the 30th week of gestation.
Study design:
Fetal and maternal free thyroxin (fT4) and TSH, thyroid antibodies in mothers and fetal
ultrasound (fetal size, morphology and fetal heart rate) were determined at the same time,
once, from 22nd to 33rd weeks of gestation.
Procedure: Cordocentesis (Cordocentesis is a highly specialized prenatal test in which a
fetal blood sample is removed from the umbilical cord and tested for genetic problems,
hormones or infections. Cordocentesis can be done at 18 weeks of pregnancy or later). Fetal
fT4 and TSH were measured from cord blood samples. Healthy pregnant subjects were directed
for cordocentesis for karyotype analysis due to age (missed previous procedures for
karyotyping).
The diagnosis of fetal hypo or hyperthyroidism was established taking into account fT4
concentrations according to the nomograms Thorpee-Beeston et al., 1996, 1991.
When fetal hyperthyroidism is diagnosed, antithyroid drugs given to the mother are
administered or adjusted. When fetal hypothyroidism is diagnosed, then the possibility of
intraamniotic thyroxin application is discussed with the mother.
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Observational Model: Case Control, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02017080 -
Fetal Thyroid Ultrasound And Fetal Thyroid Hormones
|
N/A | |
| Recruiting |
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Iodine Impact on Thyroid Function and Psychomotor Development, Observational Study in the Portuguese Minho Region
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