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CTRI Number  CTRI/2024/07/071360 [Registered on: 25/07/2024] Trial Registered Prospectively
Last Modified On: 25/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Results seen in pregnant women treated with metformin in early stages of pregnancy when glucose levels tested 2 hours after meal are raised above normal level 
Scientific Title of Study   Outcome of women with early gestational glucose intolerance treated with medical nutrition therapy and metformin versus only medical nutrition therapy randomised control trial 
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 Srilekha Thupili  
Designation  Postgraduate  
Affiliation  Lady Hardinge medical college  
Address  Department of Obstetrics and Gynecology Lady Hardinge medical college DIZ Area Connaught place New Delhi

New Delhi
DELHI
110001
India 
Phone  9553730284  
Fax    
Email  srilekhathupili.89@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pikee Saxena 
Designation  Director professor  
Affiliation  Lady hardinge medical college  
Address  Department of Obstetrics and Gynecology Lady Hardinge medical college DIZ Area Connaught place New Delhi

New Delhi
DELHI
110001
India 
Phone  9868223323  
Fax    
Email  pikeesaxena@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Srilekha Thupili 
Designation  Post graduate 
Affiliation  Lady hardinge medical college  
Address  Department of Obstetrics and Gynecology Lady Hardinge medical college DIZ Area Connaught place New Delhi

New Delhi
DELHI
110001
India 
Phone  9553730284  
Fax    
Email  srilekhathupili.89@gmail.com  
 
Source of Monetary or Material Support  
Lady hardinge medical College and associated hospitals Connaught place New Delhi 110001 
 
Primary Sponsor  
Name  Srilekha Thupili  
Address  Lady hardinge medical college,DIZ Area,Connaught place,New Delhi,110001 
Type of Sponsor  Other [Self ] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Pikee saxena   Lady hardinge medical College and associated hospitals, Connaught place New Delhi, 110001 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Srilekha Thupili   Lady hardinge medical college and associated hospitals   Department of Obstetrics and Gynecology Smt.Sucheta Kriplani Hospital Lady Hardinge medical college DIZ Area Connaught place New Delhi,110001
New Delhi
DELHI 		 9553730284

srilekhathupili.89@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE LADY HARDINGE MEDICAL COLLEGE ASSOCIATED HOSPITALS   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Early gestational glucose intolerance  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Medical nutrition therapy   Medical nutrition therapy is given to women who has early gestational glucose intolerance  
Intervention  Metformin  Metformin 250mg perorally twice daily is given along with medical nutrition therapy in women with early gestational glucose intolerance from 8 weeks of pregnancy for 29weeks or until date of delivery delivery whichever is earlier  
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Pregnant women with period of gestation less than 9 week having gestational glucose intolerance with PPBS more than 110 mg/dl 
 
ExclusionCriteria 
Details  1) women with pre-existing diabetes mellitus
2)women with pcos on metformin therapy
3)women who are having bleeding or pain abdomen
4) women who are known case of chronic medical disorder such as hypertension,chronic liver disease ,cardiovascular diseases
5) active infections like TB,HIV,Malaria,other febrile illness
6) Multiple pregnancy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Compare proportion of women with early gestational intolerance who develop gestational intolerance or gestational diabetes in medical nutrition therapy versus metformin and medical nutrition therapy   8 to 9 weeks,11 to 12 weeks,14 to 16 weeks,24 to 28 weeks,32 to 34 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Foetal & maternal complications
Foetal outcome includes LGA,FGR,preterm,subcutaneous thickness,ponderal index,proportion of newborn with admission in nursery or NICU,still birth,early neonatal deaths
Maternal outcomes include hypertension,cesarean delivery,polyhydromnios,shoulder dystocia,weight gain during pregnancy  		 37 to 40 weeks of gestation age 
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="220" 
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   Phase 2 
Date of First Enrollment (India)   15/08/2024 
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="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  

INTRODUCTION

Hyperglycaemia is now one of the most common medical conditions seen during pregnancy. Recent study has emphasized that if pregnant women have PPBS >110 mg/dl, MNT and metformin 250 mg twice a day should be started before 9 weeks and continued for achieving the target PPBG to less than 110 mg/dl.

JUSTIFICATION FOR STUDY

It is hypothesized that Metformin therapy initiated at 8 weeks will also help to prevent progression to higher thresholds of dysglycemia and prevent development of GGI and GDM in more number of patients as compared to the MNT only group.

• Therefore, this study is planned to compare proportion of women with EGGI on MNT who develop GGI or GDM with and without metformin therapy.
     RESEARCH QUESTION

Does addition of metformin to MNT prevent conversion to GGI or GDM in women with early gestational glucose intolerance comparison to MNT alone? 

HYPOTHESIS

Addition of metformin to MNT prevents conversion to GGI or GDM in women with early gestational glucose intolerance in comparison to  MNT alone

                                         OBJECTIVES

 

Primary Objective

To compare proportion of women with EGGI who develop GGI or GDM in the MNT +Metformin group versus only MNT group, 

Secondary Objective- 

To compare proportion of women who develop following fetomaternal complications in both groups

• Foetal outcome-LGA, FGR, preterm subcutaneous thickness ponderal index, proportion of newborns with admission in nursery or NICU, stillbirths, early neonatal deaths
• Maternal outcome-Hypertensive disorders of pregnancy, caesarean deliveries, polyhydramniosshoulder dystocia, weight gain during pregnancy

                                     MATERIAL AND METHODS

 

Study design: Randomised control trial

 

Study period: April 2024 to September 2025

 

Place of study: Department of obstetrics and gynaecology Lady Hardinge Medical College and Smt.

Suchetha Kriplani hospital

Study population: Pregnant women with period of gestation below 9 weeks gestation

 

Study place: Department of Obstetrics and Gynaecology, LHMC & SSKH

 

INCLUSION CRITERIA 

Pregnant women with period of gestation < 9week gestation having early gestational glucose intolerance with PPBS>110mg/dl and <120 mg /dl 

EXCLUSION CRITERIA 

1. Women with pre-existing diabetes mellitus  
2. Women with PCOS on metformin therapy 
3. Women who are having bleeding or pain in abdomen  
4. Women with known case of chronic medical disorder such as hypertension, chronic liver disease,      cardiovascular diseases,  
5. Active infection like TB, HIV, malaria, other febrile illness
6. Multiple pregnancy

    METHODOLOGY

After approval from the ECHR and CRTI registration women below 9 weeks period of gestation will undergo screening by thorough history and examination

 

                                                                   

All recruited pregnant women will undergo testing for 2-hours PPBS at 8-9 weeks and with women PPBS>110mg/dl and <120mg/dl will be recruited in the study after a written informed consent

​​                           

 

Recruited women will be allocated into 2 groups according to computer generated block random numbers

​​​                                     â€‹

 

 

Concealed allocation will be done in sealed envelopes by a colleague not directly involved in the study into 2 groups

Group 1 -Intervention group- MNT with Metformin 250mgBD/day

Group 2- Non Intervention group- MNT

 

                                                                       

 

All recruited women will undergo 2-hour PPBS at 11-12 weeks and undergo GDM screening by DIPSI test during 14-16th week, 24-28 weeks and 32-34 weeks as per DIPSI guidelines. If found to be GDM at any visit, she will be treated with standard treatment.

OUTCOME PARAMETERS

Primary Outcome Parameter : To compare proportion of women with EGGI who develop GGI or GDM in the MNT +Metformin group versus only MNT group

Secondary Outcome Parameters

To compare proportion of women who develop following fetomaternal complications in both groups 

• Fetal outcome-LGA ,FGR, preterm ,subcutaneous thickness ponderal index ,proportion of newborns with admission in nursery or NICU, stillbirths, early neonatal deaths
• Maternal outcome-Hypertensive  disorders of pregnancy, caesarean deliveries, polyhydromnios shoulder dystocia, weight gain during pregnancy

 
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