| CTRI Number |
CTRI/2025/03/081541 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
A study to improve the outcomes of mothers and babies through safe and appropriate caesarean sections. |
|
Scientific Title of Study
|
C-Safe: Optimizing maternal and perinatal outcomes through safe and appropriate caesarean sections in low-and middle-income countries (LMIC)EC.Ref No. 47_2023 |
| Trial Acronym |
C-Safe |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Inderjeet Kaur |
| Designation |
Director of Midwifery |
| Affiliation |
Fernandez Foundation |
| Address |
4-1-1230, Bogulkunta Rd, near Abids, Bogulkunta, Abids, Hyderabad, Telangana 500001, India
Hyderabad
TELANGANA
500001
India |
| Phone |
918008552503 |
| Fax |
|
| Email |
indie.k@fernandez.foundation |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Radha Reddy |
| Designation |
Head of Department - Public Health and Maternal Care |
| Affiliation |
Fernandez Foundation |
| Address |
4-1-1230, Bogulkunta Rd, near Abids, Bogulkunta, Abids, Hyderabad, Telangana 500001, India
Hyderabad
TELANGANA
500001
India |
| Phone |
8095502616 |
| Fax |
|
| Email |
drradha_reddy@fernandez.foundation |
|
Details of Contact Person
Public Query
|
| Name |
Dr Radha Reddy |
| Designation |
Head of Department - Public Health and Maternal Care |
| Affiliation |
Fernandez Foundation |
| Address |
4-1-1230, Bogulkunta Rd, near Abids, Bogulkunta, Abids, Hyderabad, Telangana 500001, India
Hyderabad
TELANGANA
500001
India |
| Phone |
8095502616 |
| Fax |
|
| Email |
drradha_reddy@fernandez.foundation |
|
|
Source of Monetary or Material Support
|
| Medical Research Council (UK)
MR/V035282/1
Medical Research Council (MRC)
Polaris House,
North Star Avenue,
Swindon,
SN2 1FL.
|
|
|
Primary Sponsor
|
| Name |
University of Birmingham |
| Address |
Research Support Services – Research Governance
Block B – Room 106, Aston Webb Building
University of Birmingham
Birmingham
B15 2TT
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
Tanzania |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vishnu Priya |
District Hospital Anakapalli |
District Government hospital Anakapalle, Room No for OP-1,2,3, LR-3 and OT-202,
Department of Obstetrics and Gynaecology
Visakhapatnam
ANDHRA PRADESH |
9441156246
vishnupriyapyush@gmail.com |
| Dr Ch Simhachalam |
District Hospital Tenali |
District Government Hospital Tenali, MCH block-Ground floor,
Department of Obstetrics and Gynaecology.
Guntur
ANDHRA PRADESH |
9849771455
chalamch89@gmail.com |
| Dr K L Bhanu Sailaja |
Government General Hospital Eluru |
Government General Hospital Ashoknagar, Room no for OP-59
LR-76, OT-77,
Department of Obstetrics and Gynaecology
West Godavari
ANDHRA PRADESH |
9949484664
drsailajakorla@gmail.com |
| Dr Anuradha |
Government General Hospital Machilipatnam |
Government General Hospital Machilipatnam, MCH block -Ground floor,
Department of Obstetrics and Gynaecology
Krishna
ANDHRA PRADESH |
9493447278
doctoranil79@gmail.com |
| Dr Sailaja |
Government General Hospital Rajahmundry |
Government General Hospital Rajahmundry, OP room no - 23,
Department of Obstetrics and Gynaecology
East Godavari
ANDHRA PRADESH |
9441339736
drsailajachodavarapu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Fernandez foundation institutional review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant participants |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Safety around cesarean sections
decision-making in the 2nd stage of labour and appropriate use of AVD |
Each site has 4000 births per annum out of which 1500 are cesarean sections. Each birth will be audited during the entire duration of study. |
| Comparator Agent |
Spontaneous and Assisted Vaginal Births (AVBs) |
currently, the AVBs are not performed. Through the study, we will be able to know how many mothers had AVBs. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects include healthcare professionals and managers in maternity wards of the selected facilities, as well as women who have given birth in the previous month.
2. Cluster: Health facilities are eligible for inclusion if:
1. Urban or peri-urban public facility
2. Secondary or tertiary-level
3. Providing comprehensive emergency obstetric care (50) over 12 months (see Box 1)
4. Minimum of 4,000 births/ year
|
|
| ExclusionCriteria |
| Details |
Sites used in the field-testing phase will not be eligible to participate in the stepped wedged randomized trial. We will exclude sites if they are not providing Comprehensive Emergency Obstetric and Newborn Care. We will also exclude sites if they were or are, part of another intervention trial, or if any components of the C-Safe interventional package were previously tested on them. Co-enrolment with sites with existing related studies will be discouraged. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Our main outcomes include the following:Caesarean section rate per month, Assisted vaginal birth rate per month, Vaginal birth rate (not including assisted vaginal births) per month, Rates of mode of birth in Robsons groups (1-4) per month, Indications for caesarean sections per month, Use of C-Safe checklists and delivery of the C-Safe packages (C-Op and C-Non) per month |
3, 6 ,9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| secondary outcomes are those on implementation, acceptability, equity and clinical outcomes |
implementation- 3 months, Acceptability - baseline, 3,6 and 12 months,
Clinical - monthly |
|
|
Target Sample Size
|
Total Sample Size="4000"
Sample Size from India="2000"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
31/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/04/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="5"
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
|
C-Safe aims to
develop, implement, and evaluate a multi-faceted intervention (C-Safe)
targeting healthcare professionals, pregnant women, families, communities and
health systems to reduce maternal and perinatal mortality and morbidity
following caesarean section (CS) in Iow- and middle-income countries (LMIC).
It is a programme
with four work packages.
- package 1 and 2 map the evidence and
prioritize components of the intervention and outcome measures.
- package 3 will co-develop and refine
the intervention in a field testing phase
- package 4 will test the intervention
(stepped wedge cluster randomised controlled trial with surveys and qualitative
research).
This registration
and these methods relate specifically to packages 3 and 4.
Given the complex
challenges that affect trial design and successful implementation in the C-Safe
intervention, a field-testing phase will be conducted ahead of the cluster
trial. The field-testing phase will use mixed-methods to understand how birth
is currently managed in the study settings, as a basis for tailoring and
adapting the implementation of the intervention.
|