Maternal Autoimmune Thyroid Disease and Fetal Thyroxin

Completed

• Conditions: Pregnancy Complicated by Hyperthyroidism; Hypothyroidism in Pregnancy

• Registration Number: NCT01528904
• Lead Sponsor: University of Belgrade

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).

Detailed 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.

Study Timeline

• Study Start: 2001-01
• Primary Completion: 2011-03
• Study Completion: 2011-06
• Study First Submitted: 2012-01-12
• Status Verified: 2012-02
• Study First Submitted QC: 2012-02-05
• Last Update Submitted: 2012-02-05
• Study First Posted: 2012-02-08
• Last Update Posted: 2012-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 83

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.

Read More

Exclusion Criteria

• Any other chronic diseases.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fetal free thyroxin	24th to 32nd week of gestation

Secondary Outcome Measures

Name	Time	Method
fetal ultrasound parameters	24th to 32nd week of gestation	at the same time as fetal free thyroxin sampling
maternal antithyroid antibodies	24th to 32nd week of gestation	sampled at the same time as the fetal free thyroxin
dose of maternal antithyroid medication (ATD)	24th to 32nd week of gestation	recorded at the same time as the fetal sampling for free thyroxin

Trial Locations

Locations (1)

Clinic for Gynecology and Obstetrics; 🇷🇸 Belgrade, Serbia