| CTRI Number |
CTRI/2023/02/050009 [Registered on: 23/02/2023] Trial Registered Prospectively |
| Last Modified On: |
23/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Awareness and risk for lower reproductive tract infections among married women |
|
Scientific Title of Study
|
“A study to assess the awareness and risk for Lower Reproductive Tract Infections (LRTIs) among married women in selected villages of Udupi District, Karnataka†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Reena Veneciya Dsouza |
| Designation |
Second year M.Sc.Nursing student |
| Affiliation |
Manipal College of Nursing, MAHE, Manipal |
| Address |
Second year M.Sc. Nursing
Department of Obstetrics and Gynecological Nursing,
Manipal College of Nursing, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9901763832 |
| Fax |
|
| Email |
reenzzflower18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Ranjani P |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Nursing, MAHE, Manipal |
| Address |
Department of Obstetrics and Gynecological Nursing,
Manipal College of Nursing, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9036252516 |
| Fax |
|
| Email |
ranjani.p@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Sweety Jousline Fernandes |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Nursing, MAHE, Manipal |
| Address |
Department of Obstetrics and Gynaecological Nursing
Manipal College of Nursing, Manipal
MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9945797188 |
| Fax |
|
| Email |
sweety.fernandes@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Reena Veneciya Dsouza |
| Address |
Final Year M.Sc.Nursing Student, Department of Obstetrics and gynaecological Nursing, Manipal College of Nursing, MAHE, Manipal |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Reena Veneciya Dsouza |
Villages of Udupi District |
Department of Obstetrics and Gynecological Nursing, Manipal College of Nursing, MAHE, Manipal
Udupi
KARNATAKA |
9901763832
reenzzflower18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Intitutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Married women belongs to 21-50 years of age group |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Who are in the age group of 21-50 years
2. Who can speak and understand Kannada
3. Who are willing to take part in the study
|
|
| ExclusionCriteria |
| Details |
1. who are health care personnel |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Awareness and risk identification about Lower reproductive tract infections among 305 married women. |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| providing with leaflet would create awareness among married woman and help them to follow ways to prevent lower reproductive tract inections. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="305"
Sample Size from India="305"
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)
|
25/02/2023 |
| 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) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
“A study to assess the awareness and risk for Lower Reproductive Tract Infections
(LRTIs) among married women in selected villages of Udupi District, Karnataka†Design of this study is nonexperimental descriptive survey design aims to assess awareness and risk for lower reproductive tract infections among married woman of age between 21-50 years of selected villages of Udupi District. This study also includes provision of leaflet to create awareness which contains information regarding lower reproductive tract infections. Samples are selected by purposive sampling technique, data is collected through structured awareness questionnaire and structured risk assessment tool. The data will be analyzed in terms of objectives and
hypothesis. Both descriptive and inferential statistics will be used to analyze
the data. The sample characteristics will be identified using
descriptive statistics (frequency and percentage) Association between awareness and
selected variables like age, education, occupation, monthly income will be
analyzed using Chi-square test. |