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A study to improve the outcomes of mothers and babies through safe and appropriate caesarean sections.

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 - C-Safe

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/081541
Enrollment
4000
Registered
2025-03-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O82- Encounter for cesarean delivery without indication

Interventions

Intervention1: 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

Sponsors

University of Birmingham
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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 monthTimepoint: 3, 6 ,9 months

Secondary

MeasureTime frame
secondary outcomes are those on implementation, acceptability, equity and clinical outcomesTimepoint: implementation- 3 months, Acceptability - baseline, 3,6 and 12 months, Clinical - monthly

Countries

India, Tanzania

Contacts

Public ContactDr Radha Reddy

Fernandez Foundation

drradha_reddy@fernandez.foundation8095502616

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026