| CTRI Number |
CTRI/2024/07/069796 [Registered on: 02/07/2024] Trial Registered Prospectively |
| Last Modified On: |
23/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Implementation research study |
| Study Design |
Other |
|
Public Title of Study
|
Implementation research to develop intervention package for reducing stillbirths |
|
Scientific Title of Study
|
Implementation Research to develop an optimized model of comprehensive intervention package and
delivery strategies to reduce stillbirth |
| 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 Reema Mukherjee |
| Designation |
Scientist E |
| Affiliation |
Indian Council of Medical Research |
| Address |
Division of RCN,
Indian Council of Medical Research, Ansari Nagar,
South West
DELHI
110029
India |
| Phone |
9953778231 |
| Fax |
|
| Email |
rima.mukerjee@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reema Mukherjee |
| Designation |
Scientist E |
| Affiliation |
Indian Council of Medical Research |
| Address |
Division of RCN,
Indian Council of Medical Research, Ansari Nagar,
South West
DELHI
110029
India |
| Phone |
9953778231 |
| Fax |
|
| Email |
rima.mukerjee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Reema Mukherjee |
| Designation |
Scientist E |
| Affiliation |
Indian Council of Medical Research |
| Address |
Division of RCN,
Indian Council of Medical Research, Ansari Nagar,
South West
DELHI
110029
India |
| Phone |
9953778231 |
| Fax |
|
| Email |
rima.mukerjee@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, Ansari-Nagar, New Delhi |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
Division of RCN,
Indian Council of Medical Research, Ansari Nagar, Delhi |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prem Mony |
Haveri |
St. Johns Research Institute, Bangalore
Haveri
KARNATAKA |
953007638
premkmony@gmail.com |
| Dr Sarmila Mazumder |
Palwal district |
Society for Applied Studies, Jatola village, near Tatarpur, Palwal district
Panchkula
HARYANA |
9811681530
sarmila.mazumder@sas.org.in |
| Dr Rutuja Patil |
Vadu Rural Health Program,KEM Hospital and Research Center,Pune |
Vadu Rural Health Program,KEM Hospital and Research Center, Pune
Pune
MAHARASHTRA |
9552512507
rutuja.patil@kemhrcvadu.org |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| IEC_SAS_Haryana |
Approved |
| IEC_StJohnsResInsti_Haveri |
Approved |
| KEM HOSPITAL RESEARCH CENTRE ETHICS COMMITTEE |
Approved |
| NOC_STJOhns_Haveri |
No Objection Certificate |
| SAS_Haryana_NOC |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O093||Supervision of pregnancy with insufficient antenatal care, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Both |
| Details |
All women in the reproductive age group and pregnant women, again specified that this is an IR study hence the study will also in its formative research interview family members, health care workers, etc |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of pregnant women covered by the package of interventions |
Baseline (0-3 months) and Endline (30-36 months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Stillbirth rate |
Baseline (0-3 months) & Endline (30-36 months). The sites will be assessing if the package of interventions resulted in a reduction of the SBR in the study sites, hence this will be assessed at baseline & then at endline |
|
|
Target Sample Size
|
Total Sample Size="7000"
Sample Size from India="7000"
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)
|
10/07/2024 |
| 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) |
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
Modification(s)
|
Despite progress in maternal and child health, India contributes the maximum number of stillbirths globally (0.34 million stillbirths annually). Additionally, there is a lack of robust data on stillbirths’ burden, timing, and causes. Interventions are scattered across multiple national guidelines with the absence of a comprehensive package and effective delivery strategies. This implementation research aims to integrate effective antepartum and intrapartum care interventions and develop a comprehensive intervention package to reduce stillbirth. The primary outcome is reduction in stillbirth as well as development of a scalable sustainable model. The creation of innovative delivery strategies will utilize an exploratory sequential mixed-methods approach. The study will be conducted in three phases: Phase 1: Formative research, baseline survey, and development of the initial Model or Model 1 of intervention delivery strategies. Phase 2: Develop a comprehensive package of interventions and effective delivery strategies through an iterative process of model optimization. Phase 3: Implementation and evaluation of the optimized model for intervention coverage and process indicators that are likely to have an impact on stillbirth reduction.
Project Coordinator : Dr. Reema Mukherjee Scientist E Division of RCN, ICMR, Ansari Nagar Delhi
|