| CTRI Number |
CTRI/2021/04/032836 [Registered on: 15/04/2021] Trial Registered Prospectively |
| Last Modified On: |
09/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Process of Care Changes |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Medical care that is given before pregnancy to improve the chances of a healthy pregnancy which includes physical exam; counseling about nutrition, exercise, medications,and treatment of certain medical conditions.
|
|
Scientific Title of Study
|
Effect of preconception care intervention on maternal nutritional status and birth outcome in low resource setting- A non-randomized control trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DHARITRI SWAIN |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AIIMS BHUBANESWAR |
| Address |
COLLEGE OF NURSING, AIIMS, BHUBANESWAR,SIJUA, KHURDHA,ODISHA
Khordha
ORISSA
751019
India |
| Phone |
09438884272 |
| Fax |
|
| Email |
dhari79@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DHARITRI SWAIN |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AIIMS BHUBANESWAR |
| Address |
COLLEGE OF NURSING, AIIMS, BHUBANESWAR,SIJUA, KHURDHA,ODISHA
Khordha
ORISSA
751019
India |
| Phone |
09438884272 |
| Fax |
|
| Email |
dhari79@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DHARITRI SWAIN |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AIIMS BHUBANESWAR |
| Address |
COLLEGE OF NURSING, AIIMS, BHUBANESWAR,SIJUA, KHURDHA,ODISHA
Khordha
ORISSA
751019
India |
| Phone |
09438884272 |
| Fax |
|
| Email |
dhari79@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research(ICMR)
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
AIIMS BHUBANESWAR |
| Address |
AIIMS, BHUBANESWAR,SIJUA, KHURDHA,ODISHA |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Mohan Hembram |
Tangi and Mendhasala community health centers of Khordha district. |
Anganwadi and club house of the selected villages. obstetric and labor unit of community health centers.
Khordha
ORISSA |
8280234652
drmhembram16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES BHUBANESWAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Married couple |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
preconception care intervention |
Preconception care intervention will be provided for minimum of 6 months before conception includes couple counseling, contraceptive education and distribution, sex education, nutritional supplementation of iron and folic acid along with multivitamins if needed and high risk screening and followed by routine standard prenatal care till delivery. |
| Comparator Agent |
standard maternal health care |
Routine prenatal monitoring care as per the standard hospital protocol. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Married women aged 18-35 years who wish to have a child within one year will be enrolled for preconception care. |
|
| ExclusionCriteria |
| Details |
History of severe health problems or any acute medical condition that impaired their ability to participate. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the effect of preconception care intervention on maternal nutritional status and birth outcomes. |
3 YEARS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2. To investigate the relationship of birth outcomes with both maternal and paternal preconception health. |
1 YEAR |
|
|
Target Sample Size
|
Total Sample Size="782"
Sample Size from India="782"
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)
|
01/05/2021 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study intends to introduce the intervention relating to nutrition and other lifestyle factor modification during the preconception period which is the ideal time to promote optimum maternal health and ensuring good pregnancy preparedness. The present study expects the integrated pre-conceptional intervention will improve maternal nutritional status and will reduce adverse birth outcomes. |