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CTRI Number  CTRI/2025/07/090915 [Registered on: 15/07/2025] Trial Registered Prospectively
Last Modified On: 13/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   To compare the HbA1C and fasting blood sugar levels with the birth weight in non diabetic females  
Scientific Title of Study   Correlation of HbA1C and fasting blood sugar with birth weight in non diabetic pregnancy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rachna 
Designation  Post graduate resident  
Affiliation  Dr. Ram Manohar Lohia Hospital  
Address  Department of Obstetrics and Gyanecology Dr. RML Hospital Baba Kharak Singh Rd near Gurudwara Bangla Sahib Connaught Place New Delhi Delhi 110001
Baba Kharak Singh Rd near Gurudwara Bangla Sahib Connaught Place New Delhi Delhi 110001
Central
DELHI
110075
India 
Phone  7678474597  
Fax    
Email  rachnalal99@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rachna 
Designation  Post graduate resident  
Affiliation  Dr. Ram Manohar Lohia Hospital 
Address  Department of Obstetrics and Gyanecology Dr. Ram Manohar Lohia Hospital

Central
DELHI
110001
India 
Phone  7678474597  
Fax    
Email  rachnalal99@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rachna 
Designation  Post graduate resident  
Affiliation  Dr. Ram Manohar Lohia Hospital 
Address  Department of Obstetrics and Gynaecology Dr. Ram Manohar Lohia Hospital

Central
DELHI
110001
India 
Phone  7678474597  
Fax    
Email  rachnalal99@gmail.com  
 
Source of Monetary or Material Support  
Department of Obstetrics and Gynaecology Dr. Ram Manohar Lohia Hospital Baba Kharak Singh Rd, near Gurudwara Bangla Sahib, Ram Manohar Lohia Hospital, Type III, Connaught Place, New Delhi, Delhi 110001 , India  
 
Primary Sponsor  
Name  Department of Obsterics and Gynaecology Dr RML Hospital Rachna 
Address  Dr RML Hospital 
Type of Sponsor  Other [Self] 
 
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 Rachna Lal   Dr RML Hospital  Departmnet of Obstetrics and Gynaecology , Dr RML Hospital
Central
DELHI 
7678474597

rachnalal99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  human healthy volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Singleton, primigravida, low risk females , 18-35 years of age 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To find out the correlation between maternal HbA1c and fasting blood sugar with birth weight in non-diabetic pregnant women.  At delivery .  
 
Secondary Outcome  
Outcome  TimePoints 
To find out the association between maternal HbA1c & fasting blood sugar with mode of delivery , APGAR , gestational age at delivery & NICU admission of baby in pregnant women.
 
At delivery . 
 
Target Sample Size   Total Sample Size="175"
Sample Size from India="175" 
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)   27/07/2025 
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="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

All consecutively registered in the antenatal clinic at <12 weeks , non diabetic women will be evaluated  by detailed  history taking and examination as per attached  proforma. The patients will be recruited according to the inclusion and exclusion criteria after obtaining their written informed consent . After 8 hours of fasting , 4 mL blood will be drawn from the antecubital vein. Of which , 2 mL will be collected into a EDTA vial for HbA1c  and  2ml will be collected into a grey vial (Sodium fluoride ) for fasting blood sugar . The women will be followed up in the antenatal clinic till delivery as per the hospital protocol. At  20-24 weeks and 32-36 weeks, 4 mL blood will be drawn from the antecubital vein for for HbA1c and for fasting blood sugars . At  the time of delivery, pregnancy outcome including neonatal birth weight will be recorded as follows :

Primary Outcome – Birth weight 

Secondary Outcome – Gestational age at delivery, mode of delivery, APGAR, admission in NICU. 

The collected data will be entered in Microsoft Excel and then will be analysed and statistically evaluated using SPSS-v23 version. Normality of each variable will be assessed by using the Kolmogorov-Simirnov test. Quantitative data will be expressed by mean, standard deviation or median with interquartile range and depends on normal distribution, groups will be tested by student t test or Mann Whitney U test. Qualitative data will be expressed in percentage and difference between the proportions will be tested by chi square test or Fisher’s exact test.

 
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