| CTRI Number |
CTRI/2024/05/067805 [Registered on: 22/05/2024] Trial Registered Prospectively |
| Last Modified On: |
18/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To know the various causes of women delivering low birth weight infants and knowing the outcomes. |
|
Scientific Title of Study
|
A one year cross sectional study of women delivering Low Birth Weight newborns, at KAHERs Dr Prabhakar Kore Hospital and Medical Research Center, Belagavi. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Samiksha S Byakod |
| Designation |
Post Graduate , Department of Obstetrics and Gynaecology |
| Affiliation |
JNMC |
| Address |
Department of Obstetrics and Gynaecology,Jawaharlal Nehru Medical College , Nehru Nagar , Belagavi, Karnataka , India
Belgaum
KARNATAKA
590010
India |
| Phone |
8007095410 |
| Fax |
|
| Email |
samikshabyakod22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Dalal |
| Designation |
Professor and guide |
| Affiliation |
JNMC |
| Address |
Department of Obstetrics and Gynaecology,Jawaharlal Nehru Medical College , Nehru Nagar , Belagavi, Karnataka , India
Belgaum
KARNATAKA
590010
India |
| Phone |
9448140343 |
| Fax |
|
| Email |
anitamgan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anita Dalal |
| Designation |
Professor and guide |
| Affiliation |
JNMC |
| Address |
Department of Obstetrics and Gynaecology,Jawaharlal Nehru Medical College , Nehru Nagar , Belagavi, Karnataka , India
Belgaum
KARNATAKA
590010
India |
| Phone |
9448140343 |
| Fax |
|
| Email |
anitamgan@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER’s Dr Prabhakar Kore Hospital and Medical Research Centre |
|
|
Primary Sponsor
|
| Name |
Dr Samiksha S Byakod |
| Address |
Jawaharlal Nehru Medical College , Nehru Nagar , Belagavi, Karnataka |
| 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 Samiksha S Byakod |
KAHER’s Dr Prabhakar Kore Hospital and Medical Research Center, Belagavi |
Deoartment Of Obstetrics and Gynaecology , KAHER’s Dr Prabhakar Kore Hospital and Medical Research Center, nehru nagar - 590010
Belgaum
KARNATAKA |
8007095410
samikshabyakod22@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 |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women presenting for delivery at KAHERs Dr Prabhakar Kore Charitable Hospital and Medical Research Centre and delivering a Low Birth Weight newborn. |
|
| ExclusionCriteria |
| Details |
Pregnant women without a proper dating scan.
Women delivering outside KLE’s Dr Prabhakar Kore Charitable Hospital and medical research centre.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Preterm babies
Small for gestation age (SGA)
Low birth weight
Foetal growth restriction (FGR)
|
during pregnancy , at delivery and postpartum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| main causes for low birth weight of newborns |
from beginning of pregnancy to 7 days post partum |
|
|
Target Sample Size
|
Total Sample Size="269"
Sample Size from India="269"
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)
|
01/06/2024 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [samikshabyakod22@gmail.com].
- For how long will this data be available start date provided 01-08-2025 and end date provided 01-01-2050?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Pregnant women presenting for delivery at KAHERs Dr Prabhakar Kore Charitable Hospital and Medical Research Centre and delivering a Low Birth Weight newborn. They will be explained about the study and will enter the study only after they accept and sign the informed consent. The patients who satisfy the inclusion criteria and are willing to participate in this study will be recruited. Participants in the study will have their baseline demographic information gathered. Following delivery , a detailed information will be collected as regards to antepartum period, Intrapartum events and the period immediately after the birth of newborn. A follow up will be done on the neonatal complications and the condition of both mother and newborn during hospital stay and at discharge. |