| CTRI Number |
CTRI/2018/07/014838 [Registered on: 12/07/2018] Trial Registered Prospectively |
| Last Modified On: |
01/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative phenomenological study |
| Study Design |
Other |
|
Public Title of Study
|
A study of the lived experiences of women with repeated abortions |
|
Scientific Title of Study
|
A Phenomenological study of the lived experiences of women with recurrent miscarriages at Employee’s State Insurance Corporation (ESIC) Medical College Hospital, Hyderabad. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nanduri Jyothi |
| Designation |
Assistant Nursing Superintendent |
| Affiliation |
ESIC Medical College Hospital |
| Address |
H.No. 101, P.No 66, keerthis bommarillu apartment, Rajiv Nagar Road no 1, Yousef guda post, Hyderabad, Telangana state, India.
N. Jyothi,151512,Assistant Nursing Superintendent, ESIC Medical College Hospital, Sanath Nagar, Hyderabad, India, 500038
Hyderabad
ANDHRA PRADESH
500045
India |
| Phone |
8978639692 |
| Fax |
|
| Email |
jyonn2013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Baby S Nayak |
| Designation |
Professor |
| Affiliation |
Manipal College of Nursing |
| Address |
Department of child health nursing, Manipal College of Nursing, Manipal Academy of Higher Education
Manipal, Karnataka, India, 576104
Udupi
KARNATAKA
576104
India |
| Phone |
09448174791 |
| Fax |
|
| Email |
baby.s@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonia |
| Designation |
Professor |
| Affiliation |
Manipal College of Nursing |
| Address |
Manipal college of Nursing, Manipal, Manipal Acadamy of Higher Education, Karnataka,India, 576104
Udupi
KARNATAKA
576104
India |
| Phone |
09844732883 |
| Fax |
|
| Email |
sonia.r@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Principle investigator
N. Jyothi
Asst Nursing Superintendent
ESIC Medical College and Hospital, Sanath nagar, Hyderabad, Telangana, India |
|
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Primary Sponsor
|
| Name |
Nanduri Jyothi |
| Address |
H.No. 101, P. No. 66, keerthis Bommarillu Apartment, Rajive nagar road no. 1, yousefguda Post, Hyderabad |
| Type of Sponsor |
Other [self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| nanduri jyothi |
ESIC Medical College Hospital |
ANS Incharge room, 2nd floor ward block
Hyderabad
ANDHRA PRADESH |
8978639692
jyonn2013@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, kasturba Medical College and kasturba Hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O038||Other and unspecified complications following complete or unspecified spontaneous abortion, Women with recurrent miscarriages , |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Women aged above 21 – 50 years with 3 miscarriages; and those who are willing to participate. Who are planning to conceive again. Women who could speak and understand Telugu and English. |
|
| ExclusionCriteria |
| Details |
Women who are associated with severe heart diseases, SLE and thrombophilia. |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| lived experiences of women with recurrent miscarriages |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| development of need based information module and effective management of women with recurrent miscarriages |
6 months |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
14/07/2018 |
| Date of Study Completion (India) |
31/12/2018 |
| 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
Modification(s)
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Type of Study: Qualitative – Phenomenological study. Aims& objectives: To explore and describe the lived experiences of women with recurrent miscarriages using a phenomenological approach. To develop and validate a need based information booklet for women with recurrent miscarriages.Departments involved: Department of obstetrics and gynaecology (inpatient and outpatient departments). Sample size : until data saturation obtained data will be collected ( approximately 15). Phenomenological descriptive research approach will be used. Materials and methods : In this study, the researcher will use intensity sampling, a type of purposive sampling to obtain the information rich cases. After obtaining written informed consent from the eligible information rich cases data will be collected from participants by in depth interview in Telugu or English language using a background proforma & an open ended questionnaire on recurrent miscarriages which focus the core areas of phenomenon to be addressed. The conversation will be audio-taped and the entire verbatim will be transcribed. The interview will be audio recorded after obtaining the consent of the participants. Data collection and data analysis will be done simultaneously. The researcher will follow the steps of phenomenology: bracketing, intuiting, analyzing and describing. Data analysis will be done by using Colaizz’s Phenomenological method.
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