| 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
|
|
|
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
|
|
|
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 |
|
|
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. |