| CTRI Number |
CTRI/2020/05/025293 [Registered on: 21/05/2020] Trial Registered Prospectively |
| Last Modified On: |
24/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Difficulties faced by pregnant women during the Covid 19 Pandemic and lockdown |
|
Scientific Title of Study
|
Challenges of pregnancy during the COVID 19 pandemic and lockdown |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajasri G Yaliwal |
| Designation |
Associate Professor |
| Affiliation |
Shri B.M Patil Medical College, Hospital and Research Centre, BLDE(DU) Vijayapura |
| Address |
Room no.2, Department of OBG, BLDE(DU) Shri BM Patil Medical College, Solpur Road, Vijayapura
Karnataka
Bhagavati Hospital Ashram Road, Opp BLDE Engg. College, Vijayapura,
Karnataka
Bijapur
KARNATAKA
586103
India |
| Phone |
09845152240 |
| Fax |
|
| Email |
ryaliwal@bldedu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajasri G Yaliwal |
| Designation |
Associate Professor |
| Affiliation |
Shri B.M Patil Medical College, Hospital and Research Centre, BLDE(DU) Vijayapura |
| Address |
Room no.2, Department of OBG, BLDE(DU) Shri BM Patil Medical College, Solpur Road, Vijayapura
Karnataka
Bhagavati Hospital Ashram Road, Opp BLDE Engg. College, Vijayapura,
Karnataka
Bijapur
KARNATAKA
586103
India |
| Phone |
09845152240 |
| Fax |
|
| Email |
ryaliwal@bldedu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Rajasri G Yaliwal |
| Designation |
Associate Professor |
| Affiliation |
Shri B.M Patil Medical College, Hospital and Research Centre, BLDE(DU) Vijayapura |
| Address |
Room no.2, Department of OBG, BLDE(DU) Shri BM Patil Medical College, Solpur Road, Vijayapura
Karnataka
Bhagavati Hospital Ashram Road, Opp BLDE Engg. College, Vijayapura,
Karnataka
Bijapur
KARNATAKA
586103
India |
| Phone |
09845152240 |
| Fax |
|
| Email |
ryaliwal@bldedu.ac.in |
|
|
Source of Monetary or Material Support
|
| Shri BM Patil Medical College, Hospital and Research Center,BLDE(DU) Vijayapura, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Shri BM Patil Medical College Hospital and Research CenterBLDE Deemed to be University |
| Address |
BLDE(DU)Shri BM PAtil Medical COllege, Hospital and Research Center, Solapur Road, Vijayapura, Karnataka, India |
| Type of Sponsor |
Private medical college |
|
|
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 Rajasri G Yaliwal |
Shri B.M. Patil Medical College, Hospital and Research Center, BLDE(DU) |
Room No 2,OPD, Department of OBG,BLDE(DU) Shri BM Patil Medical College, Solpur Road, Vijayapura
Bijapur
KARNATAKA |
09845152240
ryaliwal@bldedu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe BLDE (Deemed to be University), Vijayapura |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
All pregnant women consenting for the study |
|
| ExclusionCriteria |
| Details |
non consenting pregnant women
women below 18 years and above 40 years |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the number of pregnant women who could not avail Antenatal services during the lock down and pandemic |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To asses the deficit of transport, medical facility and medicines available to the pregnant women during the covid 19 pandemic |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="264" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/05/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study aims to identify the difficulties faces by pregnant women during the covid 19 pandemic. this could be in relation to availability of medical care, availability of the regular doctor, transporatiation, investigations and ultrasonography, availability of drugs and nutritious food, Injection tetanus toxoid etc |