| CTRI Number |
CTRI/2024/02/063052 [Registered on: 22/02/2024] Trial Registered Prospectively |
| Last Modified On: |
19/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Hysterectomy in previous caesarean section |
|
Scientific Title of Study
|
Changing trends of caesarean hysterectomy in previous caesarean section : An observational study |
| Trial Acronym |
No |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shweta Tiwari |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand Medical College |
| Address |
Obstetric and Gynaecology department, Rohilkhand Medical College Bareilly, Uttarpradesh Rohilkhand Medical College and Hospital, Bareilly, Uttar Pradesh Bareilly UTTAR PRADESH 243006 India |
| Phone |
9870952378 |
| Fax |
|
| Email |
kutkut94122@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Kiran Agarwal |
| Designation |
Professor |
| Affiliation |
Rohilkhand Medical College |
| Address |
Department of Obstetrics and Gynaecology, Rohilkhand Medical College and Hospital, Bareilly Rohilkhand Medical College and Hospital, Bareilly, Uttar Pradesh Bareilly UTTAR PRADESH 243006 India |
| Phone |
9870952378 |
| Fax |
|
| Email |
kiranbly1956@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Shweta Tiwari |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand Medical College |
| Address |
Obstetric and Gynaecology department, Rohilkhand Medical College Bareilly, Uttarpradesh Rohilkhand Medical College and Hospital, Bareilly, Uttar Pradesh Bareilly UTTAR PRADESH 243006 India |
| Phone |
9870952378 |
| Fax |
|
| Email |
kutkut94122@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of obstetrics and gynaecology |
| Address |
Rohilkhand Medical College And Hospital Bareilly, Uttar Pradesh |
| 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 Shweta Tiwari |
Rohilkhand Medical College and Hospital |
Department of obstetrics and gynaecology , Rohilkhand Medical College and Hospital Bareilly UTTAR PRADESH |
9870952378
kutkut94122@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RMCH, Bareilly, UP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O71||Other obstetric trauma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
Nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
All pregnant female with previous caesarean section 1 or more who underwent obstetrical hysterectomy
Women with obstetric hysterectomy due to various reasons like atopic postpartum bleeding, unrepairable tear and inversion of uterus |
|
| ExclusionCriteria |
| Details |
Primigravida
History of any gynaecological uterine surgeries like myomectomy, uterine septal defect and post abortal perforations( septic abortion , H. Mole) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine obstetrics hysterectomy with regards to frequency, indication, maternal risk
factors, complications in tertiary center. |
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2. To assess abnormal placentation in women with previous cesarean section is mostly Placenta previa and morbid adherent placenta which leads to Obstetrical Hysterectomies. |
1year |
| To analyze the possible reasons of very 1 high rate of Caesarean section cases |
1year |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
29/02/2024 |
| 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
|
All pregnant women who had previously delivered by C.S or Normal vaginal delivery present to our department in present pregnancy who undergoes Obstetrical Hysterectomy were considered for this study. All detailed history, clinical examination, Obstetrical examination were done and findings noted as per the protocol. USG was done in all women to assess foetal wellbeing with more attention to placental position and thickness of scar in previous CS. Women were characterised on basis of abnormal placentation and other intraoperative or postoperative complications were noted. Postnatal complication with respect to intractable haemorrhage, extension of tear in uterus, scar delicences, uterine rupture due to obstructed labour who needed lifesaving hysterectomy are taken into consideration. |