| CTRI Number |
CTRI/2024/09/073852 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
21/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
To study maternal risk factors for early onset neonatal sepsis |
|
Scientific Title of Study
|
Maternal risk factors for early onset neonatal sepsis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gargi Sharma |
| Designation |
post graduate resident |
| Affiliation |
Maulana azad medical college ,Delhi |
| Address |
GYNAE OFFICE,Room 002,Ground floor,Maternity ward, Maulana azad medical college,Delhi
Central
DELHI
110002
India |
| Phone |
9458492896 |
| Fax |
|
| Email |
gargisharma745@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shakun Tyagi |
| Designation |
Professor |
| Affiliation |
Maulana azad medical college ,Delhi |
| Address |
GYNAE OFFICE,Room 002,Ground floor,Maternity ward, Maulana azad medical college,Delhi
Central
DELHI
110002
India |
| Phone |
9458492896 |
| Fax |
|
| Email |
tyagishakun@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gargi Sharma |
| Designation |
post graduate resident |
| Affiliation |
Maulana azad medical college ,Delhi |
| Address |
GYNAE OFFICE,Room 002,Ground floor,Maternity ward, Maulana azad medical college,Delhi
Central
DELHI
110002
India |
| Phone |
9458492896 |
| Fax |
|
| Email |
gargisharma745@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana azad medical college and associated Lok nayak hospital,Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical college and associated Lok nayak hospital |
| Address |
Maulana Azad Medical college,Bahadur shah zafar marg new delhi 110002 |
| Type of Sponsor |
Government 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 Gargi Sharma |
Maulana Azad Medical College,Lok nayak hospital, Delhi |
Room 002,Maternity block, Lok Nayak Hospital,Delhi 110002
Central
DELHI |
9458492896
gargisharma745@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee,maulana azad medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O759||Complication of labor and delivery, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Mother child Dyaus delivering at lok Nayak hospital within 72hours
Cases:mother child Dyads with neonates diagnosed with early onset neonatal sepsis by positive blood culture report
Controls:mother child dyads with healthy neonates matched for period of gestation and neonatal birth weight |
|
| ExclusionCriteria |
| Details |
1.women with history of dai intervention in current pregnancy
2.immunocompromised mothers
3.mothers who are unable to communicate
4.seriously ill mothers
5.mothers in altered sensorium |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| maternal risk factors(modifiable and non modifiable)for early onset neonatal sepsis |
within 72 hours,postpartum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality improvement weight based bundle of identified modifiable risk factors. |
within 72 hours,postpartum |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/09/2024 |
| 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
|
Title of thesis: maternal risk factors for early onset neonatal sepsis This study aims at identifying modifiable and non modifiable maternal risk factors for early onset neonatal sepsis. Dyads with neonatal sepsis by positive blood culture report will be enrolled as cases. Dyads with neonates matched for period of gestation and birth weight will be enrolled as controls. These dyads will be studied with help of records and interviews for risk factors. |