| CTRI Number |
CTRI/2020/01/022834 [Registered on: 17/01/2020] Trial Registered Prospectively |
| Last Modified On: |
20/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Community based Study on the mothers who had delivered at home in Ri-Bhoi District, Meghalaya. |
|
Scientific Title of Study
|
A Cross Sectional Study on Home Deliveries Among Mothers in Ri-Bhoi District, Meghalaya. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Redolen Rose Dhar |
| Designation |
Student |
| Affiliation |
Prasanna School Of Public Health |
| Address |
Department of Health Policy
Prasanna school of Public Health
Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
08202923157 |
| Fax |
|
| Email |
redolen4181994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Redolen Rose Dhar |
| Designation |
Student |
| Affiliation |
Prasanna School Of Public Health |
| Address |
Department of Health Policy
Prasanna school of Public Health
Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
08202923157 |
| Fax |
|
| Email |
redolen4181994@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Redolen Rose Dhar |
| Designation |
Student |
| Affiliation |
Prasanna School Of Public Health |
| Address |
Department of Health Policy
Prasanna school of Public Health
Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
08202923157 |
| Fax |
|
| Email |
redolen4181994@gmail.com |
|
|
Source of Monetary or Material Support
|
| Prassana School of Public Health, MAHE, Manipal |
|
|
Primary Sponsor
|
| Name |
Redolen Rose Dhar |
| Address |
Prassana School of Public Health, MAHE, Manipal |
| Type of Sponsor |
Other [Self funded ] |
|
|
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 |
| Arathi P Rao |
National Rural Health Mission ,Ribhoi District |
Rural Area, Ri-Bhoi District Meghalaya -793102
Ri Bhoi
MEGHALAYA |
9008418848
arathi.anil@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not Applicable |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Mothers who have delivered at home from January 2018 to January 2020 |
|
| ExclusionCriteria |
| Details |
Mothers Who Are Not Willing To Give Consent Will Be Excluded From The Study
Mothers With Chronic Illness |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To identify the factors influencing home deliveries in Ri-Bhoi District ,Meghalaya.
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the barriers and facilitators that enable women to Institutional deliveries in Ri-bhoi |
6 months |
|
|
Target Sample Size
|
Total Sample Size="384"
Sample Size from India="384"
Final Enrollment numbers achieved (Total)= "384"
Final Enrollment numbers achieved (India)="384" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/01/2020 |
| Date of Study Completion (India) |
03/03/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Maternal health refers to the health of women during pregnancy, childbirth and the postpartum period .while motherhood is often a positive and fulfilling experience, for too many women it is associated with suffering, ill-health and even death. Despite several decades of global health initiative focused on maternal health, maternal mortality has proven to be an intractable problem. In India, among the National Socio-Demographic Goals for 2010, certain goals are directed towards safe delivery viz. to achieve 80% institutional deliveries and 100% deliveries by trained personnel by 2010.5 To promote institutional deliveries, provision has been made under the current Reproductive and Child Health (RCH) program, to encourage round the clock delivery services at PHC’s and CHC’s, strengthened supply of drugs, skilled man power.6but despite so many efforts institutional deliveries account 78.9% of the total deliveries in India and only 51.4% in Meghalaya.
The Methodology of the study include;
STEP 1. The subject information will be collecting from the District MCH officer.
STEP 2. The sample will be selected randomly for both qualitative and quantitative methods.
STEP 3.Face to face interview using interviewer-administered close-ended questionnaire and in-depth interview using a validated open-ended questionnaire.
STEP 4: The data collected will be entered in SPSS version 16.0. for analysis.
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