| CTRI Number |
CTRI/2025/08/092712 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Process of Care Changes
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare blood sugar control in pregnant women with gestational diabetes using telemedicine along with regular care versus regular care alone |
|
Scientific Title of Study
|
Comparison of Blood Sugar control in Gestational Diabetes Mellitus women with Telemedicine and Standard Medical Care versus Standard Medical care alone: A Randomized 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 |
LYDIA ZOHMINGLIANI |
| Designation |
Junior resident |
| Affiliation |
AIIMS PATNA |
| Address |
OBSTETRICS AND GYNAECOLOGY DEPARTMENT , AIIMS PATNA , PHULWARI SHARIFF, PATNA , BIHAR
Patna
BIHAR
801507
India |
| Phone |
8257859288 |
| Fax |
|
| Email |
lydiakhiangte1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MONIKA ANANT |
| Designation |
PROFESSOR |
| Affiliation |
AIIMS PATNA |
| Address |
OBSTETRICS AND GYNAECOLOGY , AIIMS PATNA , PHULWARI SHARIFF, PATNA , BIHAR
Patna
BIHAR
801507
India |
| Phone |
7764946249 |
| Fax |
|
| Email |
drmonikaa@aiimspatna.com |
|
Details of Contact Person
Public Query
|
| Name |
LYDIA ZOHMINGLIANI |
| Designation |
Junior resident |
| Affiliation |
AIIMS PATNA |
| Address |
Obstetrics and Gynaecology department , AIIMS PATNA , Phulwari Shariff, PATNA , BIHAR
Patna
BIHAR
801507
India |
| Phone |
8257859288 |
| Fax |
|
| Email |
lydiakhiangte1998@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS PATNA |
| Address |
AIIMS PATNA,Phulwaeri Shariff, Patna, Bihar, India , PIN- 801507 |
| Type of Sponsor |
Government medical college |
|
|
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 Lydia |
AIIMS PATNA |
Obstetrics and Gynaecology Department, AIIMS PATNA,Phulwari Shariff, Patna
Patna
BIHAR |
8257859288
lydiakhiangte1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O098||Supervision of other high risk pregnancies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine ANC Management
|
As per standard clinical care, women will be attending only GOPD visits according to patient’s status and gestational age and will also be asked to do their four-point (fasting , post- breakfast , lunch and dinner) home blood glucose profile monitoring bi weekly and document it and will be told to bring their blood sugar chart in GOPD visits and in Gopd visits, glucose readings will be analyzed from the glucometer , ketone presence and body weight will be assessed, data from the obstetrics and gynecological history and examinations will be discussed and the treatment plan will be reviewed accordingly which will be the same for both the groups. . This management will be continued until delivery. At the time of delivery upto the last day of hospital stay. |
| Intervention |
TELEMEDICINE |
Pregnant women diagnosed with GDM will be added to whats app group and will be asked to do and send their four-point home blood sugar monitoring bi weekly . Glucose data will be reviewed and manage accordingly every weekly . Every Monday, participants will receive a briefing or information ( in the form of words , image or videos ) and a task card to pinpoint or remind what they have to do. In addition to GOPD visits as per standard clinical care group, additional appointments via scheduled call or videocall can be done if required. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Singleton pregnant women diagnosed with GDM based on the 75 g oral glucose tolerance test (OGTT) by DIPSI criteria who has the ability to use a smartphone for chatting, reading, and writing.
|
|
| ExclusionCriteria |
| Details |
(1) Pregnant women with a diagnosed chronic disease like hypertension , liver dysfunction , chronic kidney disorders and other pregnancy complications
(2) those who had recent trauma or treatment with glucocorticoids
(3) Inability to use a smartphone for chatting, reading, and writing
(4) not willing to give informed consent
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Glycaemic control |
AT 4 weeks after recruitment , 32 weeks , 36 weeks and at delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
proportion of occurance of
polyhydramnios in both the groups |
During Antenatal period ( 9 months) |
| proportion of occurance of premature rupture of the membranes in both the groups. |
Antenatal period ( 9 months) |
| proportion of occurance of Gestational hypertension in both the groups. |
Antenatal period ( 9 months ) |
| proportion of occurance of Post Partum Haemorrhage in both the groups |
Post delivery (6 weeks ) |
To compare the different modes of delivery - Caeserian Section , Instrumental delivery or Normal Vaginal delivery in the Telemedicine group versus control group
|
At the time of delivery ( 1 day) |
To compare proportion of occurance of foetal adverse outcome-FGR/Macrosomia , pre-term birth or Still birth
in the Telemedicine group versus control group
|
28 weeks of POG till delivery ( 2 months) |
| To determine the acceptance or feasibility of integration of telemedicine in management of GDM. |
After delivery ( 1 day) |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
07/07/2026 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 patients visiting aiims patna gopd after applying inclusion and exclusion criteria and consenting will be considered for this study randomization will be done by which study participants will be allocated to either group a in whom telemedicine care and standard clinical care will be provided or group b in whom standard clinical care alone will be provided patients who were diagnosed with gdm according to dipsi criteria done with 75gm of anhydrous glucose dissolved in 300ml water which is taken within 5 min to 10min where blood sugar will be checked after 2 hour and if it is more than or equal to140 mg per dl she will be labelled as gestational diabetes mellitus and who met the inclusion criteria will be informed about the study and if informed consents are taken simple randomization by block randomization will be done at the randomization visit all women will attend group education regarding diet and exercise and selfmonitoring of blood glucose smbg the lifestyle education treatment goals and proposed gdm selfcare will be the same for both groups they will be asked to perform the fourpoint fasting post breakfast lunch and dinner home blood glucose profile monitoring bi weekly target capillary fasting glucose concentration less than 95 mg per dl and postprandial capillary glucose less than 120 mg per dl and target glucose levels will be explained pamphlets will be given which will provide a brief introduction to gdm group a telemedicine group women will be added to whatsapp group and will be asked to do and send their four point home blood glucose monitoring bi weekly and these glucose levels will be sent in whatsapp group chat advice will be given only if it is too high or too low otherwise follow up visits will be in person visits as standard medical care glucose data will be reviewed and manage accordingly every weekly if patients did not managed to take blood sugar test and send it on time they will be reminded to take it and send it in addition to the gopd visits which will be the same as other groups appointments via scheduled call or videocall can be done if required and every monday participants will receive a briefing or information which could be in the form of words image and videos to encourage patients to take an active part in the control of their gdm and a task card to pinpoint the basic requirements like diet advice and examples of meals and exercise if any questions regarding the project or pregnancy or gdm 1 hour weekly will be provided for answers this weekly management will be continued until delivery group b as per standard clinical care women will be attending only gopd visits according to patients status and gestational age and will also be asked to do their four point home blood glucose profile monitoring bi weekly and document it and will be told to bring their blood sugar chart in gopd visits and in gopd visits glucose readings will be analyzed from the glucometer ketone presence and body weight will be assessed data from the obstetrics and gynecological history and examinations will be discussed and the treatment plan will be reviewed accordingly which will be the same for both the groups this management will be continued until delivery at the time of delivery up to last day of hospital stay data collection of neonatal birth weight time of delivery like full term birth or preterm birth delivery mode cesarean section or vaginal delivery or instrumental delivery or any nicu care provided to the baby like rds fgr macrosomia hypoglycemic episodes shoulder dystocia and related birth injuries and hyperbilirubinaemia or neonatal jaundice in the baby and any occurrence of stillbirth will be collected and will be compared to the other group data analysis to be done in terms of comparison of glycaemic control between telemedicine group and control group and the occurrence of adverse outcome between the two groups analysis will also be done regarding the acceptance and feasibility of integrating telemedicine in management of gdm patients feedback like comfort ease or difficulty and acceptance of using whatsapp or telemedicine as a tool for management of gdm |