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CTRI Number  CTRI/2024/06/069281 [Registered on: 20/06/2024] Trial Registered Prospectively
Last Modified On: 17/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to access the complications arising for the mother and the baby after an emergency caesarean section  
Scientific Title of Study   Fetomaternal Outcomes in Emergency Primary Caesarean Sections In Women Delivering At Dr Prabhakar Kore Hospital Belagavi A One Year Cross Sectional Study 
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 Angeline Veronica A 
Designation  MS Post Graduate  
Affiliation  Jawaharlal Nehru Medical College  
Address  Department of Obstetrics and Gynaecology, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  7708365917  
Fax    
Email  joeveronica16@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M B Bellad 
Designation  Professor and Guide 
Affiliation  Jawaharlal Nehru Medical College  
Address  Department of Obstetrics and Gynaecology, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9448124893  
Fax    
Email  mbbellad@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr M B Bellad 
Designation  Professor and Guide 
Affiliation  Jawaharlal Nehru Medical College  
Address  Department of Obstetrics and Gynaecology, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9448124893  
Fax    
Email  mbbellad@hotmail.com  
 
Source of Monetary or Material Support  
KAHERs Dr. Prabhakar Kore Hospital and Medical Research Centre, Nehru Nagar, Belagavi 590010, Karnataka, India 
 
Primary Sponsor  
Name  Dr Angeline Veronica A 
Address  Department of Obstetrics and Gynaecology, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi 590010 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Angeline Veronica   KAHERs Dr Prabhakar Kore Hospital and Medical Research Centre   G-1,Labour room, Department of Obstetrics and Gynaecology, KAHERs Dr Prabhakar Kore Hospital and Medical Research Centre, Nehru Nagar, Belagavi
Belgaum
KARNATAKA 		 7708365917

joeveronica16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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   NIL  
Comparator Agent  NIL   NIL  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  1. Gestational age 28 weeks or more
2. Any pregnant women who deliver by undergoing Primary Caesarean Sections - Primigravida , women with one or more previous vaginal deliveries, previous instrumental deliveries, previous assisted deliveries, previous stillbirth, previous intrauterine death
 
 
ExclusionCriteria 
Details  1. Patients who had undergone any previous uterine surgeries like previous Caesarean Sections, previous myomectomy
2. Previous abortions
3. Electively planned Caesarean Sections  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the fetomaternal Outcomes following Emergency Primary Caesarean Sections in a tertiary health care centre  Intra operative and immediate post-op period till 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the indications, the intra operative and post operative findings of emergency primary Caesarean Sections   1 month 
 
Target Sample Size   Total Sample Size="404"
Sample Size from India="404" 
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)   01/07/2024 
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   Unlike elective or planned caesarean sections, emergency primary caesarean sections are often unplanned and arise due to urgent medical concerns like fetal distress, placental abruption or other complications that require swift resolution. 
The decision to perform an emergency primary caesarean section is typically made in real time,  based on critical assessment of the mother and the fetus. 
Timely and well executed emergency primary caesarean sections are vital in addressing the unforseen complications, reducing potential risk and ensuring best possible outcomes for both mother and the baby.
In this comprehensive study we aim to investigate and evaluate distinct indications for emergency primary caesarean sections in both primigravida and multigravida.
Understanding the specific factors influencing the decision for caesarean delivery in both groups is crucial for enhancing maternal and neonatal health care outcomes.
This research seeks to inform evidence based practices and guide health care professionals in tailoring optimal delivery strategies based on individualized patient needs, thereby promoting safer and more effective maternity care.
 
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