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CTRI Number  CTRI/2024/03/064907 [Registered on: 28/03/2024] Trial Registered Prospectively
Last Modified On: 27/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare two different insulin regimes for better pregnancy outcome 
Scientific Title of Study   Comparison of efficacy of PREMIXED SPLIT INSULIN REGIME with MULTIPLE SPLIT INSULIN REGIME on diabetes complicating pregnancy – A Randomized Controlled 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 Keerthana 
Designation  post graduate 
Affiliation  Sri manakula vinayagar medical college and hospital 
Address  Department of Obstretics and Gynecology, OPD Room number 68, Sri manakula vinayagar medical college, madagadipet, kalitheerthalkuppam,

Pondicherry
PONDICHERRY
605107
India 
Phone  9042401597  
Fax    
Email  keerthanabakthavachalam@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Poomalar 
Designation  Professor 
Affiliation  Sri manakula vinayagar medical college and hospital 
Address  Department of obstretics and gynecology, OPD number 68, Room number 4, Sri manakula vinayagar medical college and hospital, madagadipet, kalitheerthalkuppam

Pondicherry
PONDICHERRY
605107
India 
Phone  9442044679  
Fax    
Email  poomalarpragash@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Keerthana 
Designation  Post graduate 
Affiliation  Sri manakula vinayagar medical college and hospital 
Address  Department of Obstretics and Gynecology, OPD Room number 68, Sri manakula vinayagar medical college, madagadipet, kalitheerthalkuppam,

Pondicherry
PONDICHERRY
605107
India 
Phone  9042401597  
Fax    
Email  keerthanabakthavachalam@gmail.com  
 
Source of Monetary or Material Support  
sri manakula vinayagar medical college and hospital madagadipet kalitheerthalkuppam pondicherry 605107 
 
Primary Sponsor  
Name  sri manakula vinayagar medical college and hospital 
Address  madagadipet kalitheerthalkuppam pondicherry 605107 
Type of Sponsor  Private medical college 
 
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 Keerthana  Sri Manakula Vinayagar Medical College and Hospital  Department of Obstretics and Gynecology, OPD Room number 68, Sri Manakula Vinayagar Medical College and Hospital, Madagadipet, Kalitheerthalkuppam,
Pondicherry
PONDICHERRY 
9042401597

keerthanabakthavachalam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMVMCH - ETHICS COMMITTEE  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, (2) ICD-10 Condition: O241||Pre-existing type 2 diabetes mellitus, in pregnancy, childbirth and the puerperium, (3) ICD-10 Condition: O243||Unspecified pre-existing diabetesmellitus in pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Multiple Split Insulin Regimen (HUMAN REGULAR INSULIN [Actrapid] + HUMAN INTERMEDIATE INSULIN [Insulatard])  Group B Participants will receive Multiple Split Insulin Regimen (HUMAN REGULAR INSULIN [Actrapid] + HUMAN INTERMEDIATE INSULIN [Insulatard]) The patient will be started with Actrapid. If the blood sugars are between 120 – 160mg/dl, 4 units will be started. If between 160 – 200mg/dl, 6 units will be given and if it is above 200mg/dl the patient will be started on 8 units and the dose will be titrated based on sugar levels. Based on Post-meal values, regular insulin (actrapid) will be titrated. Based on Pre-dinner values, morning dose intermediate insulin will be added (4 units) and titrated by increments of 2 units. Based on 2 AM and FBS, the night dose intermediate will be titrated. Insulin will be given till DELIVERY according to the blood sugar values.  
Intervention  Premixed Split Insulin Regimen (MIXTARD INSULIN – 30% RAPID ACTING INSULIN AND 70% ISOPHANE INSULIN)  Premixed Split Insulin Regimen (MIXTARD INSULIN – 30% RAPID ACTING INSULIN AND 70% ISOPHANE INSULIN) Group A Participants will receive Premixed Split Insulin Regimen. 2/3rd of the dose is given in the morning with breakfast, 1/3rd of the dose is given at night with dinner. The dose of insulin (both morning and night dose) will be started based on the patient’s blood sugar level. If the blood sugars are between 120 – 160mg/dl, 4 units will be started. If between 160 – 200mg/dl, 6 units will be given and if it is above 200mg/dl the patient will be started on 8 units. And the dose of insulin will be titrated accordingly. Insulin will be given till DELIVERY according to the blood sugar values.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  All pregnant women with viable, singleton pregnancy with diabetes complicating pregnancy at ≤ 36 weeks in need of insulin therapy, regardless of oral hypoglycemic agents usage 
 
ExclusionCriteria 
Details  Patients who are known allergic to insulin 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the efficacy of different insulin regimes in achieving tight glycemic control in diabetes-complicating pregnancy  Hypoglycemic episodes
Glycemic control at 28 – 30 weeks
Glycemic control at 34 – 36 weeks
Number of days required to achieve sugar control 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the efficacy of different regimes on maternal & neonatal outcomes  UTI infection rates checked during every Antenatal visits,
Polyhydramnios diagnosed by USG done at 24 to 28 weeks, 34 to 36 weeks,
Prolonged labor observed at 1st & 2nd stage of labor,
Shoulder dystocia during delivery,
PPH during delivery & till 6 weeks of postpartum,
whether is there any IUD or Stillbirth,
APGAR score at 1 minute & 5 minutes after the birth of the child,
Neonatal hypoglycemia will be checked after birth of baby at 2, 6, 12, 24, 48 hours if baby is found hypoglycemic

 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 4 
Date of First Enrollment (India)   08/04/2024 
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  

Gestational diabetes mellitus is a global health problem, affecting up to 5 million women in India annually. The estimated prevalence of GDM varies from <1 to 28% in different countries. As of 2010, there were an estimated 22 million women with diabetes between the ages of 20 and 39 & an additional 54 million women in this age group with impaired glucose tolerance (IGT) or pre-diabetes with the potential to develop GDM if they become pregnant. A recent study summarizing 69 studies involving 1,778,706 Indian adults showed that between 1972 and 2019, the prevalence of T2DM increased in rural and urban India from 2.4% to 15% and from 3.3% to 19.0%, respectively. GDM is associated with the prevalence of T2DM, so as the prevalence of diabetes increases, the number of women affected by GDM also increases.

If the blood sugars are not controlled, various complications can occur. MATERNAL COMPLICATIONS such as Abortion, Polyhydramnios, Pre-eclampsia, Prolonged labor, Obstructed labor, Cesarean section, Uterine atony, Postpartum hemorrhage, and Infection may occur. The fetal risks are Spontaneous abortion, Intra-uterine death, Stillbirth, Macrosomia, Congenital malformation, Shoulder dystocia, Birth injuries, Neonatal hypoglycemia, and Infant respiratory distress syndrome. Neonatal complications in GDM are Hypoglycemia, Hyperbilirubinemia, Respiratory distress syndrome, Hypocalcemia, Polycythemia, Hypomagnesaemia, and Neurodevelopmental abnormalities. In the long term, the patient may develop Obesity and Type 2 diabetes mellitus. Therefore, we need strict sugar control during pregnancy to prevent the maternal, fetal, neonatal, and long-term complications of diabetes complicating pregnancy.

In addition to medical nutrition therapy and Oral hypoglycemic drugs, insulin may be given to control blood sugar levels. According to FOGSI guidelines, Insulin is the drug of first choice and Metformin can be considered for the treatment of GDM after 20 weeks of gestation.

It is recommended to use either Injection Actrapid or Mixtard insulin during pregnancy. However, FOGSI recommends only injection human premix insulin 30/70. Pregnancy can cause fasting hypoglycemia(due to insulin-independent glucose uptake by the placenta), and postprandial hyperglycemia (as a result of diabetogenic placental hormones). A fixed ratio of insulin in the form of premixed insulin can’t be adjusted as per the requirements of pregnant women as compared to multiple split dose. As the pharmacokinetics of insulin (difference in peak insulin action and duration of action) varies within different ratios of insulin, glycemic control without hypoglycemia might vary with these two insulin regimens. Hence, we aimed  to compare the efficacy of different insulin regimes in pregnancy to achieve tight glycemic control and its outcome on pregnancy. We are excluding insulin analogs from our study due to their high cost, which makes it unaffordable for most people with low socioeconomic status.

 
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