| CTRI Number |
CTRI/2024/05/067386 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
ambidirectional cohort study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Development And Validation of a model For Vaginal Birth After Caesarean Section |
|
Scientific Title of Study
|
Development And Validation Of A Predictive Model For Vaginal Birth After Caesarean Section Based On Demographic, Clinical And Ultrasound Based Factors |
| 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 K Aparna Sharma |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room number - 715, 7th Floor Mother and Child Block, Department of Obstetrics and Gynaecology AIIMS New Delhi
110029
South
DELHI
110029
India |
| Phone |
9711824415 |
| Fax |
|
| Email |
kaparnasharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Aparna Sharma |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room number - 715, 7th Floor Mother and Child Block, Department of Obstetrics and Gynaecology AIIMS New Delhi
110029
DELHI
110029
India |
| Phone |
9711824415 |
| Fax |
|
| Email |
kaparnasharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Aparna Sharma |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room number - 715, 7th Floor Mother and Child Block, Department of Obstetrics and Gynaecology AIIMS New Delhi
110029
DELHI
110029
India |
| Phone |
9711824415 |
| Fax |
|
| Email |
kaparnasharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| not required, observational study |
|
|
Primary Sponsor
|
| Name |
No funds required as it is institute based PG thesis project |
| Address |
AIIMS New 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 |
| Riya Bagdi |
aiims new delhi |
Mother and child block
Pincode -110029
South
DELHI |
8107168108
riyabagdi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee AIIMS New Delhii |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant patients who had previous C-section and are willing for Trial of labour after C-section |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Inclusion Criteria
For retrospective data
Records will be reviewed of all pregnant women with a history of previous one caesarean section and a transverse incision in the lower uterine segment who underwent TOLAC with gestation ≥37 weeks and singleton live birth
For Prospective Study
Inclusion Criteria
1. Pregnant woman with
2. Previous one low transverse cesarean section
3. 37 or more weeks of gestation
4. vertex singleton presentation
5. no known contraindication to Trial of Labour
6. Those who are willing to undergo TOLAC should have given informed consent
|
|
| ExclusionCriteria |
| Details |
For prospective studyExclusion Criteria
1. Expected Baby weight of 3.5 kg
2. Morbid obesity
3. Multiple pregnancy
4. Non-cephalic presentation
5. Placenta previa/abruption
6. Previous history of extension of caesarean scar
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prediction of successful TOLAC using the developed model among the prospective pregnancies in women
1. Undergoing spontaneous labour
2. Undergoing induction of labour with PGE2
3. Undergoing induction of labour with Mechanical induction
|
Prediction of successful TOLAC using the developed model among the prospective pregnancies in women
1. Undergoing spontaneous labour
2. Undergoing induction of labour with PGE2
3. Undergoing induction of labour with Mechanical induction
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Efficacy of USG measured scar thickness in improving the predictive ability of the developed model |
34-36 weeks |
|
|
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)
|
05/02/2025 |
| 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="6"
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 develop a predictive model for Vaginal birth after Caesarean section(VBAC) using a retrospective data set of women who underwent VBAC and then to validate the developed model in women undergoing VBAC |