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CTRI Number  CTRI/2018/07/014947 [Registered on: 18/07/2018] Trial Registered Prospectively
Last Modified On: 21/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized Factorial Trial 
Public Title of Study
Modification(s)  		 Lifestyle interventions to prevent diabetes in pregnant mothers 
Scientific Title of Study
Modification(s)  		 Pregnancy-Related Interventions in Mothers at Risk for gestational Diabetes in Asian India and Low and middle income countries (PRIMORDIAL Study)  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrJiji Elizabeth Mathews 
Designation  Professor 
Affiliation  Christian Medical College and Hospital 
Address  Professor and Head Unit 5 Department of Obstetrics and Gynaecology Christian Medical College and Hospital Vellore

Vellore
TAMIL NADU
632004
India 
Phone  04162283387  
Fax    
Email  coronistrial@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  DrJiji Elizabeth Mathews 
Designation  Professor 
Affiliation  Christian Medical College and Hospital 
Address  Professor and Head Unit 5 Department of Obstetrics and Gynaecology Christian Medical College and Hospital Vellore

Vellore
TAMIL NADU
632004
India 
Phone  04162283387  
Fax    
Email  coronistrial@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  DrJiji Elizabeth Mathews 
Designation  Professor 
Affiliation  Christian Medical College and Hospital 
Address  Professor and Head Unit 5 Department of Obstetrics and Gynaecology Christian Medical College and Hospital Vellore

Vellore
TAMIL NADU
632004
India 
Phone  04162283387  
Fax    
Email  coronistrial@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Biotechnology Newton Fund Global Research Programme 
 
Primary Sponsor  
Name  Department of Biotechnology Newton Fund Global Research Programme 
Address  Ministry of Science and Technology Government of India New Delhi 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Gambia
India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jiji Mathews  Christian Medical College and Hospital, .  OG- OPD Room Nos. 16-27, Dept. of Obstetrics & Gynaecology Ida Scudder Road Vellore
Vellore
TAMIL NADU 		 04162283387

coronistrial@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Committee, CMC, Vellore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O244||Gestational diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Controls  Standard Care 
Intervention  Three arms  3 arms namely i) diet (yogurt intervention) ii) Physical activity iii) Diet and physical activity  
 
Inclusion Criteria
Modification(s)  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Eligible pregnant women should be
(1) aged 18 years or older
(2) Gestational age 16 weeks or lesser
(3) Not currently on any medications (except iron, calcium or folic acid supplements, thyroxine supplement for hypothyroidism, low dose aspirin for pre-eclampsia)
AND
(4) Meet at least one of the following criteria that qualifies them as “high-risk”: for GDM
• Booking BMI ≥25kg/m2,
• Age ≥25 years,
• First-degree relative with diabetes,
• Previous pregnancy with GDM and/or pre- eclampsia/eclampsia,
• Previous pregnancy with large baby (≥3.5kg),
• History of PCOD/impaired fasting glucose)

 
 
ExclusionCriteria 
Details  Women will be excluded if they meet one or more of the following criteria
(1) GDM diagnosed prior to screening visit based on IADPSG criteria or documented raised HbA1C, i.e., either fasting glucose ≥5.1 mmol/L or 1h glucose ≥10.0 mmol/L or 2h glucose ≥8.5 mmol/L, or a documented HbA1c of ≥6.5% at first booking
(2) History of pre-gestational diabetes
(3) Multiple gestation in the current pregnancy
(4) History of severe hyperemesis in the first trimester
(5) Uncontrolled pre-gestational or gestational hypertension (BP>150/100 mmHg) or currently on treatment hypertension
(6) History of recurrent (≥2) first trimester spontaneous abortions or stillbirths
(7) Previous child born with congenital anomalies
(8) History of significant ante- or post-partum haemorrhage in the previous pregnancy.
(9) Pregnancy following in-vitro fertilization or any assisted reproductive technology
(10) Previous or current psychiatric illness on medication, epileptic seizures or on antiepileptic medication
(11) women meeting absolute contraindications for physical activity during pregnancy as recommended by the ACOG such as heart disease, restrictive lung disease, incompetent cervix/cerclage, pregnancies at risk for premature labour, gestational hypertension (BP>150/100 mmHg), severe anemia.
(12) Physical disability to PA and/or known lactose intolerance
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Incidence of gestational diabetes mellitus diagnosed based on IADPSG criteria at 26-28 weeks or fasting plasma glucose ≥ 92mg/dl (≥5.1 mmol/l) at week 32
 		 OGTT will be performed at 26-28 weeks and/or fasting plasma glucose at week 32 of gestation.
 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
(1) fasting blood glucose at 32 weeks
(2) gestational weight gain
(3) Maternal BP
(4) proportion of instrumental/caesarean deliveries
(5) Postpartum haemorrhage (PPH)
(6) pre-eclampsia and eclampsia
(7) blood loss at delivery,
(8) Pre-term births (less than 37 weeks of gestation)
(9) Foetal macrosomia
(10) birth weight, birth length and APGAR score at 1 and 5 minutes of birth.
(11) Barriers to interventions in pregnancy. 		 Maternal outcomes:
(1) Week 32: absolute values of fasting glucose
(2) Randomisation to Week 32: Gestational weight gain
(3) At delivery: proportion of instrumental/caesarean deliveries, PPH, blood loss at delivery
(4) Week 28: diagnosis of preeclampsia or eclampsia
New born outcomes will be recorded at delivery.
Barriers to interventions in pregnancy, at screening and at 32 weeks of gestation.  
 
Target Sample Size
Modification(s)  		 Total Sample Size="1856"
Sample Size from India="928" 
Final Enrollment numbers achieved (Total)= "809"
Final Enrollment numbers achieved (India)="1056" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/01/2019 
Date of Study Completion (India) 01/03/2019 
Date of First Enrollment (Global)  01/01/2019 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

The study is a 2x2 factorial, open-labelled, multi-centre randomized controlled trial to be conducted in Vellore, South India and The Gambia, West Africa. “High-risk” pregnant women (n=1,856) aged ≥18 years and less than 16 weeks of gestational age, with at least one risk factor for developing GDM, will be randomized to one of four arms (i) yoghurt (ii) Physical activity (PA) (iii) yoghurt + PA or (iv) standard antenatal care. Randomised women will be followed until 32 weeks of gestation with total active intervention lasting for a minimum of 14 weeks. The primary endpoint is incidence of GDM diagnosed at 26-28 weeks GA using IADPSG criteria or elevated fasting glucose at 32 weeks. A secondary endpoint is fasting plasma glucose concentration at 32 weeks gestation. Other outcomes include maternal blood pressure, gestational weight gain, intrapartum and neonatal outcomes. Analysis will be both by intention to treat and per-protocol.  Continuous outcome measurements will be analysed using multiple linear regression and binary variables by logistic regression.

 
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