NCT03929991

Maternal Cesarian Section Infection (MACSI) in Sierra Leone

Maternal Cesarian Section Infection (MACSI) in Sierra Leone: an Observational Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Doctors with Africa - CUAMM · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: —

Summary

Up to 1 in 5 women in Africa who deliver their baby by cesarean section get a wound infection. Surgical site infections (SSIs) are largely preventable, but they represent a considerable burden for health-care systems, particularly in low-income and middle-income countries. The prevention of these infections is complex and requires the integration of a range of preventive measures before, during, and after surgery. The aim of the proposed project is to determine the risk factors of Surgical Site Infection post-Cesarean Section in women admitted to Princess Christian Maternity Hospital (PCMH) in Freetown, Sierra Leone. Secondary aims are to determine the incidence of SSI and the predictors of a negative outcome in women with post-CS SSI.

Detailed description

Rationale: More than 1 in 10 people who have surgery in low and middle-income countries (LMICs) get surgical site infection. People's risk of SSI in LMICs is 3 to 5 times higher than in high-income countries. Up to 1 in 5 women in Africa who deliver their baby by cesarean section get a wound infection. Surgical site infections (SSIs) are largely preventable, but they represent a considerable burden for health-care systems, particularly in low-income and middle-income countries. The prevention of these infections is complex and requires the integration of a range of preventive measures before, during, and after surgery. Objective: The aim of the proposed project is to determine the risk factors of Surgical Site Infection post-Cesarean Section in women admitted to Princess Christian Maternity Hospital (PCMH) in Freetown, Sierra Leone. Secondary aims are to determine the incidence of SSI and the predictors of a negative outcome in women with post-CS SSI. Study design: This is a prospective case-control (1:3 ratio) study. Study population and Methods: All women admitted or already hospitalized with suspected or confirmed infection after C/S will be screened for inclusion in the study as a case. Case confirmation will be clinically established by an infectious disease expert. For each case, 3 patients undergoing the C/S on the same day and admitted to the same ward but not presenting SSI, will be selected as controls. Sample size: No formal sample size calculation is performed. Main study parameters/primary endpoints: SSI post C/S will be classified as: Superficial incisional surgical site infection, Deep incisional surgical site infection; Organ/space surgical site infection Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: Because all proceedings in the method of this study are based on common clinical practice, there are no serious adverse events (SAEs) expected.

Conditions

• Infection
• Cesarean Section Complications
• Site Infection
• Maternal Death

Interventions

Type	Name	Description
OTHER	Observational	To record social and clinical characteristics

Timeline

• Start date: 2018-05-01
• Primary completion: 2019-10-01
• Completion: 2020-05-01
• First posted: 2019-04-29
• Last updated: 2019-04-30

Locations

1 site across 1 country: Sierra Leone