An observational study in Infection, Cesarean Section Complications and Site Infection, sponsored by Doctors with Africa - CUAMM. Status unknown at 1 site in Sierra Leone. Open to female participants. Per ClinicalTrials.gov, last updated 2019-04-30.
Sponsored by Doctors with Africa - CUAMM · Observational
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.
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.
2,093 studies on the registry are indexed under Infections; 364 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 300 across 685 observational studies indexed under Infections.
Browse Infections studies →Doctors with Africa - CUAMM is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant women undergoing a C/S in an urban tertiary referral maternity hospital PCMH, Freetown (population served: 1'500'000; n. of total deliveries in 2017: 6'861; number of C/S in 2017: 2'028 ).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The following conditions will not be considered as outcome, unless they present with systemic repercussion due to infection. For example:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.SSI post C/S will be classified as: * Superficial incisional surgical site infection, * Deep incisional surgical site infection, * Organ/space surgical site infection.
Other: Observational
For each case, 3 patients undergoing the C/S on the same day and admitted to the same ward but not presenting Surgical Site Infection
Other: Observational
To record social and clinical characteristics
Incidence
To determine the incidence of SSI after CS at PCMH during the study period
Time frame: From hospital admission to hospital discharge, an overage of 1 month
Prevalence of Main Features
To describe the main features of SSI after CS in women admitted at PCMH
Time frame: From hospital admission to hospital discharge, an overage of 1 month
Prevalence of Negative Outcome
To assess predictor of negative outcomes of SSI after CS
Time frame: From hospital admission to hospital discharge, an overage of 1 month
Screening of Risk factors
To determine the risk factors of Surgical Site Infection post Cesarean Section
Time frame: From hospital admission to hospital discharge, an overage of 1 month
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2018 (actual). Primary completion is estimated for Oct 2019, 17 months after the start.
Of 257 non-industry observational studies under Infections, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 79. This study's planned 17 months is below that.
Counting every sponsor, half of 295 studies reached it within 35 months; a quarter within 18 and three quarters within 67.
Infections covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Doctors with Africa - CUAMM