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临床试验/CTRI/2024/07/071121
CTRI/2024/07/071121招募中不适用

Exploring the association between thyroid dysfunction in pregnancy and Gestational diabetes mellitus

未提供1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
1
主要终点
1) Possible connection between thyroid dysfunction in pregnancy and gestational diabetes mellitus

研究概览

简要总结

Thyroid dysfunction and gestational diabetes present notable challenges during pregnancy leading to a range of maternal complications such as miscarriage, gestational hypertension, preeclampsia, preterm delivery, cesarean section deliveries and birth trauma. In addition to maternal complications, GDM and thyroid dysfunction are linked to various perinatal and neonatal morbidities including macrosomia, increased birth weight, shoulder dystocia, respiratory distress syndrome, neonatal hypoglycemia, hyperbilirubinemia, low birth weight, congenital hypothyroidism, hypocalcemia, impaired neurodevelopment in the child, etc. Placental human chorionic gonadotropin, sharing structural similarities with TSH transiently suppresses TSH secretion in the first trimester. Simultaneously, serum concentrations of FT4 and FT3 rise regulating key metabolic processes such as glucose, protein and lipid metabolism Yanachkova V et al study observed that higher TSH and FT3 concentration, lower FT4 concentrations and higher FT3:FT4 ratios may indicate an increased risk of developing GDM. Further research was needed to validate these results and explore the relationship between thyroid dysfunction and gestational diabetes. Hindi E. Stohl et al study conducted at John Hopkins showed a higher incidence of GDM in women with hypothyroidism compared to those with hyperthyroidism. Women with hypothyroidism had significantly higher rates of cesarean delivery. Huang K et al study showed a significant association between higher TSH levels in early pregnancy and an elevated risk of gestational diabetes, particularly in women with a pre pregnancy BMI more than or equal to 24kg/m2. Stressing the importance of early thyroid function evaluation, the findings propose potential preventive measures for GDM, especially in those with her BMI.

In proposed study, pregnant women visiting OPD/ANC at Kasturba Hospital fitting into inclusion criteria will be recruited.  TSH will be sent as a part of routine antenatal investigation. If TSH value is found to be abnormal, patient will be referred to Department of Endocrinology for evaluation. As part of evaluation FT4, anti TPO levels will be sent. Patient will then be classified into one of the five following categories: 1) Euthyroid (TSH- normal) 2) Subclinical hypothyroid (TSHelevated, FT4-normal) 3) Overt Hypothyroid (TSH- elevated, FT4- decreased) 4) Hyperthyroidism (TSH- decreased, FT4 increased) 5) Anti TPO positive.  In subsequent ANC visit, screening for GDM will be done either by Glucose tolerance test or 75 grams glucose challenge test. According to  IADPSG( Fasting blood glucose 92 mg/dl 1 hour post glucose value 180 mg/dl 2 hour post glucose value 153 mg/dl )Patient will be labelled as GDM if any one of the above mentioned values in deranged OR based on DIPSI guidelines (Blood sugar value > 140mg/dl).  Patient will then be grouped into either  Thyroid dysfunction in pregnancy with GDM or Thyroid dysfunction in pregnancy without GDM. Patient will be followed up till delivery. Perinatal and maternal outcomes will be studied. Collected data will be analyzed

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • We are recruiting women 1) Carrying a singleton pregnancy 2) Willing to deliver in Kasturba Hospital, Manipal.

排除标准

  • Pregnant women with a confirmed diagnosis of diabetes mellitus.
  • Women with k/c/o thyroid carcinoma and have undergone treatment for the same.
  • Cases involving multiple pregnancies (e.g., twins, triplets).
  • Patients with other significant medical conditions that may impact the study outcomes (e.g. severe cardiovascular diseases, chronic hypertension, renal disease).

结局指标

主要结局

1) Possible connection between thyroid dysfunction in pregnancy and gestational diabetes mellitus

时间窗: Baseline, 24-28 weeks of pregnancy, time of delivery, time of discharge

2) Finding out the specific thyroid disorder with which association of GDM is more

时间窗: Baseline, 24-28 weeks of pregnancy, time of delivery, time of discharge

3) Maternal and fetal outcome of pregnancy having thyroid dysfunction and GDM

时间窗: Baseline, 24-28 weeks of pregnancy, time of delivery, time of discharge

次要结局

  • Maternal and fetal outcome in pregnancies affected by the concurrent presence of diabetes mellitus and thyroid dysfunction(Upto 1 week post termination of pregnancy)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Akanksha Sethi

Kasturba Hospital, Manipal

研究点 (1)

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