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CTRI Number  CTRI/2024/07/071121 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On: 25/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   How thyroid problems in pregnancy affect risk of developing diabetes in pregnancy and its impact on mother and baby health 
Scientific Title of Study   Exploring the association between thyroid dysfunction in pregnancy and Gestational diabetes mellitus 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Akanksha Sethi 
Designation  Junior Resident 
Affiliation  Kasturba Hospital, Manipal 
Address  Department of Obstetrics and Gynaecology, Kasturba Hospital, Manipal, Karnataka- 576104

Udupi
KARNATAKA
576104
India 
Phone  9980210608  
Fax    
Email  akanksha.kmcmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajeshwari G Bhat 
Designation  Additional Professor 
Affiliation  Kasturba Hospital, Manipal 
Address  Department Of Obstetrics And Gynaecology, Kasturba Hospital, Manipal, Karnataka- 576104

Udupi
KARNATAKA
576104
India 
Phone  9448624379  
Fax    
Email  rajigbhat@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Rajeshwari G Bhat 
Designation  Additional Professor 
Affiliation  Kasturba Hospital, Manipal 
Address  Department Of Obstetrics And Gynaecology, Kasturba Hospital, Manipal, Karnataka- 576104

Udupi
KARNATAKA
576104
India 
Phone  9448624379  
Fax    
Email  rajigbhat@yahoo.co.in  
 
Source of Monetary or Material Support    
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajeshwari G Bhat  Kasturba Hospital, Manipal  Department of Obstetrics and Gynaecology, Women and Child block, Kasturba Hospital, Manipal
Udupi
KARNATAKA 		 9448624379

rajigbhat@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O244||Gestational diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  We are recruiting women
1) Carrying a singleton pregnancy
2) Willing to deliver in Kasturba Hospital, Manipal 
 
ExclusionCriteria 
Details  1) Pregnant women with a confirmed diagnosis of diabetes mellitus.
2) Women with k/c/o thyroid carcinoma and have undergone treatment for the same.
3) Cases involving multiple pregnancies (e.g., twins, triplets).
4) Patients with other significant medical conditions that may impact the study outcomes (e.g. severe cardiovascular diseases, chronic hypertension, renal disease). 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) Possible connection between thyroid dysfunction in pregnancy and gestational diabetes mellitus
2) Finding out the specific thyroid disorder with which association of GDM is more
3) Maternal and fetal outcome of pregnancy having thyroid dysfunction and GDM 		 Baseline, 24-28 weeks of pregnancy, time of delivery, time of discharge 
 
Secondary Outcome  
Outcome  TimePoints 
Maternal and fetal outcome in pregnancies affected by the concurrent presence of diabetes mellitus and thyroid dysfunction  Upto 1 week post termination of pregnancy 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="20" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   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
 
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