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Maternal Autoimmune Thyroid Disease and Fetal Thyroxin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Svetlana Spremovic Radjenovic, University of Belgrade
ClinicalTrials.gov Identifier:
NCT01528904
First received: January 12, 2012
Last updated: February 5, 2012
Last verified: February 2012
  Purpose

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).


Condition
Pregnancy Complicated by Hyperthyroidism
Hypothyroidism in Pregnancy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Fetal Thyroid Hormones Concentration In Hyperthyroid or Hypothyroid Pregnant Women

Resource links provided by NLM:


Further study details as provided by University of Belgrade:

Primary Outcome Measures:
  • Fetal free thyroxin [ Time Frame: 24th to 32nd week of gestation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • fetal ultrasound parameters [ Time Frame: 24th to 32nd week of gestation ] [ Designated as safety issue: Yes ]
    at the same time as fetal free thyroxin sampling

  • maternal antithyroid antibodies [ Time Frame: 24th to 32nd week of gestation ] [ Designated as safety issue: Yes ]
    sampled at the same time as the fetal free thyroxin

  • dose of maternal antithyroid medication (ATD) [ Time Frame: 24th to 32nd week of gestation ] [ Designated as safety issue: Yes ]
    recorded at the same time as the fetal sampling for free thyroxin


Enrollment: 83
Study Start Date: January 2001
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   23 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Groups are selected from State tertiary referral centre for Gynecology and Obstetrics

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01528904

Locations
Serbia
Clinic for Gynecology and Obstetrics
Belgrade, Serbia, 11000
Sponsors and Collaborators
University of Belgrade
Investigators
Principal Investigator: Svetlana Spremovic-Radjenovic, MD PhD Medical School of the University of Belgrade
  More Information

Additional Information:
Publications:
Responsible Party: Svetlana Spremovic Radjenovic, assistant professor, gynecologist and obstetrician, subspecialist in endocrinology, University of Belgrade
ClinicalTrials.gov Identifier: NCT01528904     History of Changes
Other Study ID Numbers: 318/VII-4/3 3186
Study First Received: January 12, 2012
Last Updated: February 5, 2012
Health Authority: Serbia: Ethics Committee

Keywords provided by University of Belgrade:
pregnancy
autoimmune thyroid disease
fetal thyroid hormones
antithyroid antibodies
ultrasound parameters

Additional relevant MeSH terms:
Hyperthyroidism
Hypothyroidism
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on November 23, 2014