| CTRI Number |
CTRI/2024/03/064582 [Registered on: 21/03/2024] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Effect of community-based pre-conception care package on maternal and child health outcomes |
|
Scientific Title of Study
|
Evaluating the effect of community-based pre-conception care package through trained nurses on pre-conception health, maternal and child health outcomes: a stepped-wedge cluster randomized implementation trial. |
| Trial Acronym |
EPIC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhishek V Raut |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Institute of Medical Sciences, Sevagram |
| Address |
Dr Sushila Nayar School of Public Health (incorporating the Department of Community Medicine), Old hospital building, Bapu Kuti
road, Mahatma Gandhi Institute of Medical Sciences, Sevagram
Wardha
MAHARASHTRA
442102
India |
| Phone |
7083170552 |
| Fax |
07152-284333 |
| Email |
abhishekvraut@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini Kalantri |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Institute of Medical Sciences, Sevagram |
| Address |
Dr Sushila Nayar School of Public Health (incorporating the Department of Community Medicine), Old hospital building, Bapu Kuti
road, Mahatma Gandhi Institute of Medical Sciences,Sevagram
Wardha
MAHARASHTRA
442102
India |
| Phone |
7440977777 |
| Fax |
|
| Email |
ashwini@mgims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuj Mundra |
| Designation |
Assoc. Professor |
| Affiliation |
Mahatma Gandhi Institute of Medical Sciences, Sevagram |
| Address |
Dr Sushila Nayar School of Public Health (incorporating the Department of Community Medicine), Old hospital building, Bapu Kuti
road, Mahatma Gandhi Institute of Medical Sciences,Sevagram
Wardha
MAHARASHTRA
442102
India |
| Phone |
9028207622 |
| Fax |
|
| Email |
anuj_mundra87@mgims.ac.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
Indian Council of Medical Research V. Ramalingaswami Bhawan,
P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
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 Abhishek V Raut |
Mahatma Gandhi Institute of Medical Sciences |
Room No.- 5 First floor
Department of
Community Medicine
Old hospital building
Bapu kuti road MGIMS
Sevagram
Wardha
MAHARASHTRA
Wardha
MAHARASHTRA |
7083170552
abhishekvraut@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Institute of Medical Sciences Sevagram Institutional Ethics Committee For Research on Human Subjects |
Approved |
| Mahatma Gandhi Institute of Medical Sciences Sevagram Institutional Ethics Committee For Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Eligible women in 19 to 45 years age group in the villages who are yet to complete their family and have not adopted any permanent methods of contraception. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comprehensive community-based Pre-conception care package |
The intervention would consist of implementing a comprehensive PCC package through PCC clinics in the villages through trained ANMs. The PCC package will have evidence-based interventions or messages for health promotion related to Nutrition, Tobacco and Alcohol use, Contraception, Reproductive health, Responsive caregiving, Vaccination, Genetic conditions, Environmental health, Infertility, Interpersonal violence and Mental health as suggested by WHO. |
| Comparator Agent |
Routine service through existing programs |
The population in control period will continue to receive the routine care through the existing under RMNCH+A program and no additional activities would be conducted during the control period. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Only those who give written informed consent for participation in trial will be included in the study.
2. Only those women who are permanent resident of the village and willing to stay in the study area for the next two years will be included
|
|
| ExclusionCriteria |
| Details |
1. The eligible couples wherein either of the partner have adopted any permanent method of contraception will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Pre-conception health among women from eligible couple as ascertained by the proportion of women who would enter pregnancy in good health without undernutrition, anaemia and depression. |
Five time points every six monthly starting after six months of intervention with endline conducted at 36 months. Beyond these a baseline assessment will be conducted. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
The secondary outcomes include improved maternal & child health outcomes, such as reductions in stillbirth rate, neonatal mortality rate (NMR), infant mortality rate (IMR), & severe maternal morbidities (e.g., pre-eclampsia, gestational diabetes, maternal depression, hemorrhage, & abortion).
Other outcomes include lower rates of low birth weight, stunting at age one, delayed first pregnancies, longer birth intervals, & more planned pregnancies. |
A cohort of potential beneficiaries will be followed from conception through pregnancy outcomes & until the child turns one year old for live births.
|
The secondary outcomes include examining the factors that facilitate or hinder the implementation & use of the PCC package, assessing the feasibility of the intervention using the RE-AIM framework, & estimating the unit cost of delivering community-based PCC services accounting for direct, indirect, & opportunity costs, aiding future policy advocacy for the PCC package.
In addition, sub-clinical parameters related to anemia, including serum ferritin & vitamin B12 levels, will be measured. |
Implementation outcomes & cost of implementation will be estimated through endline survey & barrier analysis at 36 months
Biochemical profiling will be conducted on a subsample of 1,920 individuals (640 each) at baseline, an interim survey 3 at 18 months, & endline. |
|
|
Target Sample Size
|
Total Sample Size="3200"
Sample Size from India="3200"
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)
|
01/04/2024 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [abhishekvraut@gmail.com].
- For how long will this data be available start date provided 01-01-2027 and end date provided 31-12-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
Initiating interventions before conception have positive effect on maternal and child health. However, evidence on how to deliver Preconception care (PCC) at community level in rural under-resourced settings is lacking. The aim of this study is to evaluate the effect of delivering village level PCC through trained Auxiliary Nurse Midwives (ANMs) using a Social Franchising approach on pre-conception health status among eligible women and maternal and child health outcomes in rural Wardha India. The study is an open cohort stepped wedge cluster randomized trial (swCRT) with repeated cross-sectional sampling for outcome measurement. Over the duration of study, all 96 villages will be randomized using a computer-generated list of random numbers to intervention and control arm in a stepped wedge manner involving random and sequential crossover of clusters from control to intervention until all clusters are exposed. In the intervention arm, a comprehensive PCC package will be delivered to the registered beneficiaries by trained Auxiliary Nurse Mid-wives (ANMs). The Village Health Nutrition and Sanitation Committees (VHNSC) will be catalysed to act as Social Franchisee for establishing pre-conception clinics in their village. The trained ANMs will deliver the PCC package services to the eligible women through these clinics. The registered beneficiaries will receive active PCC package intervention till conception and then will integrate with routine primary health care services to ensure ante-natal, intra-natal and post-natal care continuum. Community-based events will be undertaken through the VHNSC for creating a social norm. The villages in the control arm will receive the standard package of interventions as per the existing Government health programs. The intervention will be implemented for 2 years. This study will provide evidence and a model for delivering PCC at community level through trained ANMs by utilizing existing platform VHNSC and can inform India’s Reproductive, Maternal, Newborn Child and Adolescent Health (RMNCH+A) programme for maximizing the gains for maternal and child health. If successful, the PCC package can be tested at scale in other rural regions of India |