| CTRI Number |
CTRI/2023/02/050062 [Registered on: 24/02/2023] Trial Registered Prospectively |
| Last Modified On: |
22/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
fear,anxiety and quality of life
during pregnacy with history of adverse pregnancy outcome |
|
Scientific Title of Study
|
: “A study to assess fear, anxiety and quality of life, with history of adverse pregnancy outcomes among pregnant women in selected hospitals 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 |
ELMY JACOB |
| Designation |
2nd year Msc nursing student |
| Affiliation |
Manipal College Of Nursing |
| Address |
vandan, kuchikkad,kote village,katapadi
Manipal, MAHE
Udupi
KARNATAKA
574105
India |
| Phone |
7994510155 |
| Fax |
|
| Email |
elmy.jacob1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Sweety Jousline Fernandes |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College Of Nursing |
| Address |
Department of Obstetrics and Gynecology Nursing
MCON,MAHE,MANIPAL
Manipal, MAHE
Udupi
KARNATAKA
576107
India |
| Phone |
9945797188 |
| Fax |
|
| Email |
Sweety.fernandes@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
MrsRanjaniP |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College Of Nursing |
| Address |
Department of Obstetrics and Gynecology Nursing
MCON,MAHE,MANIPAL
Manipal, MAHE
KARNATAKA
576107
India |
| Phone |
9036252516 |
| Fax |
|
| Email |
ranjani.p@manipal.edu |
|
|
Source of Monetary or Material Support
|
| The study is being conducted in Kasturba Hoapital Maniapl |
|
|
Primary Sponsor
|
| Name |
Elmy Jacob |
| Address |
Vandan House
Kuchikkad,Kote village
Katapady
Udupi |
| 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 |
| MrsRanjani p |
KASTURBA Hospital |
Kasturba hospital manipal, Udupi(dist)
Udupi
KARNATAKA |
9036252516
elmy.jacob1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O092||Supervision of pregnancy with other poor reproductive or obstetric history, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
(i) Married women
(ii) Gestational age between 8-32 weeks
(iii) History of one or more adverse pregnancy outcomes
(iv) Ability to understand and answer the questionnaires
(v) Willingness to participate in the study
|
|
| ExclusionCriteria |
| Details |
(i) Severe medical condition
(ii) Those who are not willing to participate
(iii) Unmarried women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assessing fear and quality of life among pregnant women with history of adverse pregnancy outcomes |
notify physician if needed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| refer the patient for appropriate management |
councelling, divertional therapy |
|
|
Target Sample Size
|
Total Sample Size="322"
Sample Size from India="322"
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)
|
27/02/2023 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study title" study to assess fear, anxiety and quality of life, with history of adverse pregnancy outcomes among pregnant women in selected hospitals of Udupi district Karnataka."The main aim of the study is to identify the pregnant women who is having fear and anxiety towards current pregnancy and to refer them for appropriate treatment by notifying them to the primary consultant, also to provide the information regarding the important care which needed to a fruitful outcome. |