| CTRI Number |
CTRI/2023/02/049616 [Registered on: 10/02/2023] Trial Registered Prospectively |
| Last Modified On: |
08/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Caesarean Delivery and its Associated risk factors in Antenatal women classified by The Robson’s Ten Group Classification System |
|
Scientific Title of Study
|
Frequency of Caesarean Delivery and its Associated risk factors in Antenatal women classified by The Robson’s Ten Group Classification System
An Analytical cross sectional Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 49/2022 version 1 dated 28/9/22 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
FARAH PRAKASH JIANDANI |
| Designation |
Resident |
| Affiliation |
NKP Salve Institute of medical Sciences and reserch centre and Lata Mangeshkar hospital |
| Address |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital
Department of Gynaecology
third floor
Police nagar
digdoh Hills
Hingna
Nagpur 440019
Maharashtra
Nagpur
MAHARASHTRA
440019
India |
| Phone |
09819921238 |
| Fax |
|
| Email |
farahpj95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
FARAH PRAKASH JIANDANI |
| Designation |
Resident |
| Affiliation |
NKP Salve Institute of medical Sciences and reserch centre and Lata Mangeshkar hospital |
| Address |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital
Department of Gynaecology
third floor
Police nagar
digdoh Hills
Hingna
Nagpur 440019
Maharashtra
MAHARASHTRA
440019
India |
| Phone |
09819921238 |
| Fax |
|
| Email |
farahpj95@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Savita Somalwar |
| Designation |
Associate Professor |
| Affiliation |
NKP Salve Institute of medical Sciences and Research and Lata Mangeshkar Hospital |
| Address |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital
Department of Gynaecology
third floor
Police nagar
digdoh Hills
Hingna
Nagpur 440019
Maharashtra
Nagpur
MAHARASHTRA
440019
India |
| Phone |
09158920941 |
| Fax |
|
| Email |
somalwar.sa@gmail.com |
|
|
Source of Monetary or Material Support
|
| NKP Salve Institute OF Medical Sciences and Research Centre |
|
|
Primary Sponsor
|
| Name |
NKP Salve Institute of medical Sciences and Research Centre |
| Address |
Department of Gynaecology and Obstetrics
Third Floor
Hingna
Nagpur 440019 |
| 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 |
| Farah Jiandani |
NKP Salve Institute of medical Sciences and Research Centre and Lata Mangeshkar Hospital |
Department of Obstetrics and Gynaecology
third floor
Digdoh hills
Hingna Nagpur 440019
Nagpur
MAHARASHTRA |
09819921238
farahpj95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, (2) ICD-10 Condition: O096||Supervision of young primigravidaand multigravida, (3) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, (4) ICD-10 Condition: O601||Preterm labor with preterm delivery, (5) ICD-10 Condition: O602||Term delivery with preterm labor, (6) ICD-10 Condition: O630||Prolonged first stage (of labor), (7) ICD-10 Condition: O632||Delayed delivery of second twin, triplet, etc., (8) ICD-10 Condition: O641||Obstructed labor due to breech presentation, (9) ICD-10 Condition: O300||Twin pregnancy, (10) ICD-10 Condition: O403||Polyhydramnios, third trimester, (11) ICD-10 Condition: O100||Pre-existing essential hypertension complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
All Women admitted in antenatal ward for delivery |
|
| ExclusionCriteria |
| Details |
Not willing to consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Frequency of caesarian section per group of Robsons Ten group classification |
Once on delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Obstetric Risk factors and Socio demographic and socio economic factors |
Once on admission |
|
|
Target Sample Size
|
Total Sample Size="690"
Sample Size from India="690"
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)
|
10/02/2023 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
As per WHO recommendation, all healthcare facilities should do a periodical audit of their institutional cesarean sections using Robson 10 group classification. This helps to identify the group of patients and indications that are contributing maximum to the cesarean sections and what measures can be taken to reduce the rate in each group. Understanding caesarian rates is challenging as many factors to contribute to overall rate, Factors such as urban-rural residence and education and maternal morbidity may have an influence and hence it is important to study the association of maternal risk factors and sociodemographic factors to caesarian delivery hence we aim to study the frequency of cesarean deliveries in antenatal women as classified by Robsons Ten group Classification and the association between selected sociodemographic and obstetric factors in cesarean deliveries in women classified accordingly |