| CTRI Number |
CTRI/2024/07/070934 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
18/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study Of Pregnancy Outcome in Various High Risk Pregnancies- A One year prospective Cross Sectional Study |
|
Scientific Title of Study
|
A Study of Pregnancy Outcome in Various High Risk Pregnancies-A Prospective Cross Sectional Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kusha Vashistha |
| Designation |
MS post graduate |
| Affiliation |
Jawaharlal Nehru medical College |
| Address |
Department of Obstetrics & Gynecology
Jawaharlal Nehru medical College
Nehru nagar
Belagavi
Belgaum
KARNATAKA
590001
India |
| Phone |
9351877350 |
| Fax |
|
| Email |
kushavashistha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M C Metgud |
| Designation |
Professor and Guide |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Obstetrics and Gynaecology
KAHERs Jawaharlal Nehru Medical College
Nehru nagar
Belagavi
Belgaum
KARNATAKA
590001
India |
| Phone |
9164693333 |
| Fax |
|
| Email |
metm@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M C Metgud |
| Designation |
Professor and Guide |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Obstetrics and Gynaecology
KAHERs Jawaharlal Nehru Medical College
Nehru nagar
Belagavi
Belgaum
KARNATAKA
590001
India |
| Phone |
9164693333 |
| Fax |
|
| Email |
metm@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Dr Prabhakar kore Hospital and medical research centre
Belagavi
Karnataka
Pin 590010 |
|
|
Primary Sponsor
|
| Name |
Dr Kusha Vashistha |
| Address |
Department of obstetrics and gynaecology
Jawaharlal Nehru medical College
Belagavi |
| 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 |
| Dr Kusha Vashistha |
KAHERs Dr Prabhakar kore Hospital and medical research centre |
Room no 10
OBGYN OPD
Department of obstetrics and gynaecology
KAHERs Dr Prabhakar kore Hospital and medical research centre
Nehru nagar
Belagavi
Karnataka
Pin 590010
Belgaum
KARNATAKA |
9351877350
kushavashistha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O099||Supervision of high risk pregnancy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
48.00 Year(s) |
| Gender |
Female |
| Details |
1. Cases with any risk factors
2. Gestational age more than 28 weeks with live fetus
3. All booked and unbooked cases |
|
| ExclusionCriteria |
| Details |
1. Cases with gestational age less than 28 weeks
2. Antenatal cases with intrauterine death before admission |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pregnancy outcome in various high risk pregnancies |
During pregnancy, at delivery and postpartum till 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Perinatal outcome |
At delivery & postpartum till 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="230"
Sample Size from India="230"
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)
|
29/07/2024 |
| 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 Applicable |
| 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
|
Identification of patients at high risk for complications is the most fundamental aspect of good antenatal care. Obstetric risk scoring is a way of recognizing ,documenting and analysing antepartum and intrapartum factors to predict the development of complications in the mother , foetus and infant . |