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临床试验/NCT01528904
NCT01528904已完成不适用

Fetal Thyroid Hormones Concentration In Hyperthyroid or Hypothyroid Pregnant Women

University of Belgrade1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2001年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
83
试验地点
1
主要终点
Fetal free thyroxin

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
23 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • Any other chronic diseases.

结局指标

主要结局

Fetal free thyroxin

时间窗: 24th to 32nd week of gestation

次要结局

  • fetal ultrasound parameters(24th to 32nd week of gestation)
  • maternal antithyroid antibodies(24th to 32nd week of gestation)
  • dose of maternal antithyroid medication (ATD)(24th to 32nd week of gestation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Svetlana Spremovic Radjenovic

assistant professor, gynecologist and obstetrician, subspecialist in endocrinology

University of Belgrade

研究点 (1)

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