| CTRI Number |
CTRI/2024/03/064406 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the incidence of anal sphincter injuries in postpartum women using introital ultrasound. |
|
Scientific Title of Study
|
To study the incidence of obstetric anal sphincter injuries (OASIS) in postpartum women using introital ultrasound |
| 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. Rajesh Kumari |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
7th floor, Department of obstetrics and Gynaecology, Mother and Child Block, AIIMS , NewDelhi
South
DELHI
110029
India |
| Phone |
9911226176 |
| Fax |
|
| Email |
drrajeshkumari@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rajesh Kumari |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
7th floor, Department of Obstetrics and Gynaecology,Mother and Child block, AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9911226176 |
| Fax |
|
| Email |
drrajeshkumari@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Kavitha Chekuri |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no - 27, Hostel 19, Patanjali Hostel, AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9392349013 |
| Fax |
|
| Email |
drkavithachekuri@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS
Ansari Nagar
New Delhi |
|
|
Primary Sponsor
|
| Name |
No funds required as it is institute based PG thesis project |
| Address |
AIIMS New Delhi, Ansari Nagar, Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rajesh Kumari |
AIIMS New Delhi |
Room no- 731,
7th Floor ,
Department of obstetrics and gynaecology
Mother and Child Block
AIIMS
Ansari Nagar
New Delhi
South
DELHI |
9911226176
drrajeshkumari@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Comittee AIIMS New Delhi |
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 |
| Intervention |
NIL as it is an observational study |
NIL as it is an observational study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.women with no history suggestive of anal incontinence prior to pregnancy
2.all grades of perineal tear in this delivery |
|
| ExclusionCriteria |
| Details |
1. prior pelvic organ prolapse
2. neurological diseases like multiple sclerosis, spina bifida |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To correlate the severity of symtoms of anal incontinence with various grades of OASIS detected on clinical examination and introital ultrasound |
0, 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of OASIS in normal vaginal deliver, instrumental delivery and caesarean section |
0,6 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
28/03/2024 |
| 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 Yet Recruiting |
| 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
|
To know how many women develop anal sphincter injuries after childbirth using introital ultrasound. |