| CTRI Number |
CTRI/2024/06/068509 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Health services used by pregnant women before pregnancy |
|
Scientific Title of Study
|
Utilization of preconception care and its associated factors among pregnant women in urban area of Delhi |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ivikali Achumi |
| Designation |
Postgraduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Dept. of Community Medicine
3rd floor, Pathology block
2, Bahadur Shah Zafar Marg, near Delhi gate, Maulana Azad Medical College campus, Balmiki Basti, New Delhi, Delhi
NEW DELHI
110002
Central
DELHI
110002
India |
| Phone |
9990847713 |
| Fax |
|
| Email |
iviachumi24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Amod Laxmikant Borle |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room number 362
Dept. of Community Medicine
3rd floor, Pathology block
2, Bahadur Shah Zafar Marg, near Delhi gate, Maulana Azad Medical College campus,
NEW DELHI
110002
Central
DELHI
110002
India |
| Phone |
01123239271376 |
| Fax |
|
| Email |
dramodborle@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ivikali Achumi |
| Designation |
Postgraduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Dept. of Community Medicine
3rd floor, Pathology block
2, Bahadur Shah Zafar Marg, near Delhi gate, Maulana Azad Medical College campus,
NEW DELHI
110002
Central
DELHI
110002
India |
| Phone |
9990847713 |
| Fax |
|
| Email |
iviachumi24@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ivikali Achumi |
| Address |
Dept. of Community Medicine
3rd floor, Pathology block
2, Bahadur Shah Zafar Marg, near Delhi gate, Maulana Azad Medical College campus, Balmiki Basti, New Delhi, Delhi
NEW DELHI
110002 |
| Type of Sponsor |
Other [Individual] |
|
|
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 Ivikali Achumi |
UHTC Gokalpuri under Dept. of Community Medicine, Maulana Azad Medical College |
BLOCK A, 120
Ganga Vihar
DELHI
North East
DELHI |
9990847713
iviachumi24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.Antenatal women irrespective of period of gestation visiting ANC OPD of UHTC Gokalpuri.
2.ANC women residing in an urban area of Delhi for the last 6 months before conception.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant women requiring urgent referral. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Proportion of antenatal women utilizing preconception care
2. Pattern of PCC use by antenatal women
|
8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Association of factors with utilization of preconception care in the study population
2. Proportion of ANC women having good knowledge about PCC in the study population
|
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
17/06/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Preconception care
is the provision of biomedical, behavioral, and social health interventions to
women and couples before conception occurs. Preconception care aims to promote maternal health,
bring about behavioral and environmental change, and overall improve the birth
and child health outcomes. The principal component of preconception care
includes risk assessment, information and advice on health promotion, specific
counseling, and interventions like screening of pre-existing medical conditions
and their management. This study aims to find out the utilization of
preconception care and its associated factors in antenatal women.The study will take place at the
Urban Health Training Centre (UHTC) in Gokalpuri, which is part of the
Department of Community Medicine at Maulana Azad Medical College in New Delhi.
It will be a facility-based cross-sectional study. The study will be conducted over one
year. Antenatal
women visiting UHTC Gokalpuri for antenatal care (ANC).
|