Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01528904
Other study ID # 318/VII-4/3 3186
Secondary ID
Status Completed
Phase N/A
First received January 12, 2012
Last updated February 5, 2012
Start date January 2001
Est. completion date June 2011

Study information

Verified date February 2012
Source University of Belgrade
Contact n/a
Is FDA regulated No
Health authority Serbia: Ethics Committee
Study type Observational

Clinical Trial 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).


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 83
Est. completion date June 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Female
Age group 23 Years to 45 Years
Eligibility Inclusion Criteria:

- 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.

- 20 healthy pregnant women in control group were directed for cordocentesis due to age.

Exclusion Criteria:

- Any other chronic diseases.

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
Serbia Clinic for Gynecology and Obstetrics Belgrade

Sponsors (1)

Lead Sponsor Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Fetal free thyroxin 24th to 32nd week of gestation Yes
Secondary fetal ultrasound parameters at the same time as fetal free thyroxin sampling 24th to 32nd week of gestation Yes
Secondary maternal antithyroid antibodies sampled at the same time as the fetal free thyroxin 24th to 32nd week of gestation Yes
Secondary dose of maternal antithyroid medication (ATD) recorded at the same time as the fetal sampling for free thyroxin 24th to 32nd week of gestation Yes
See also
  Status Clinical Trial Phase
Recruiting NCT02017080 - Fetal Thyroid Ultrasound And Fetal Thyroid Hormones N/A
Recruiting NCT04288531 - Iodine Impact on Thyroid Function and Psychomotor Development, Observational Study in the Portuguese Minho Region

External Links