InfectionMACSINCT03929991
Maternal Cesarian Section Infection (MACSI) in Sierra Leone
An observational study of Infection and Cesarean Section Complications, run by Doctors with Africa - CUAMM at 1 site in Sierra Leone.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infection, Cesarean Section Complications, Site Infection
- What is being tested?
- Observational
- How many people
- 1,000 participants
- Where
- 1 siteSierra Leone
- Study dates
- 1 May 2018to 1 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Child, Adult, Older adult
Study population: 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 ).
Who may be able to join
- All pregnant women undergoing a C/S in on the hospitals during the study period will be eligible to participate in this study.
Who cannot join
- The following conditions will not be considered as outcome, unless they present with systemic repercussion due to infection. For example:
- Vaginosis, candidiasis
- Lower tract urinary infection
- Fungal infections of the skin (athlete's foot, jockitch, ringworm, and yeast infections)
- Otitis
- Pharyngitis
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- Herpes simplex, Herpes Zoster (Shingles)
- Uncomplicated chronic infection
- Sexually transmitted infections (Gonorrhoea, Syphilis, Trichomonas, Chlamydia, Hepatitis, HIV)
- Tuberculosis
- Bacterial colonization (presence of microorganisms without clinical signs/symptoms)
- Known vaginal, urethral and/or rectal GBS colonization
- Asymptomatic bacteriuria
- Known oropharyngeal colonization
- Non-infectious hypothermia/hyperthermia (e.g. related to epidural, thyroid storm, prostaglandin administration) during hospital stay
Trial locations and contacts
1 site in 1 country.
Sierra Leone1 site, 1 recruiting
- Recruiting
Princess Christian Maternity Hospital
Freetown
Francesco Di Gennaro, 3924804707, cicciodigennaro@yahoo.it
About this study
Official title: Maternal Cesarian Section Infection (MACSI) in Sierra Leone: an Observational Study
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.
Read the 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.
- Being tested
- Observational
- Keywords
- Site infection, Sierra Leone, Africa, Cesarean Infection, Maternal Mortality
- Medical subject headings
- Infections, Maternal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
To record social and clinical characteristics
| Study group | Role | What they receive |
|---|---|---|
| Case | 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. Receives: Other: Observational | |
| Control | 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 Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence
To determine the incidence of SSI after CS at PCMH during the study period
Measured: From hospital admission to hospital discharge, an overage of 1 month
Secondary outcomes (3)
Prevalence of Main Features
To describe the main features of SSI after CS in women admitted at PCMH
Measured: 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
Measured: 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
Measured: From hospital admission to hospital discharge, an overage of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start1 May 2018
- Primary completion1 Oct 2019 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Doctors with Africa - CUAMM
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bari, University of Palermo
- Responsible party
- Sponsor
- Investigators
- Giovanni Putoto, PhD, Principal investigator, Department of operational research Doctors with Africa CUAMM Padova, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929991
- Sponsor's protocol ID
- 1902
- Acronym
- MACSI
- Status last verified
- Apr 2019
- First submitted
- 24 Apr 2019
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Cesarian Section Infection (MACSI) in Sierra Leone: an Observational Study
- ClinicalTrials.gov ID
- NCT03929991
- Acronym / sponsor ID
- MACSI / 1902
- Keywords
- Site infection, Sierra Leone, Africa, Cesarean Infection, Maternal Mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Doctors with Africa - CUAMMUniversity, hospital or other
- Collaborators
- University of Bari, University of Palermo
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 29 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Other: ObservationalAll 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. |
| Control | – | Other: ObservationalFor each case, 3 patients undergoing the C/S on the same day and admitted to the same ward but not presenting Surgical Site Infection |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- 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 ).
Key inclusion criteria (1 listed)
- All pregnant women undergoing a C/S in on the hospitals during the study period will be eligible to participate in this study.
Key exclusion criteria (15 listed)
- The following conditions will not be considered as outcome, unless they present with systemic repercussion due to infection. For example:
- Vaginosis, candidiasis
- Lower tract urinary infection
- Fungal infections of the skin (athlete's foot, jockitch, ringworm, and yeast infections)
- Otitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalTo record social and clinical characteristics | Other | Case, Control |
Primary outcome
Incidence
Time frame: From hospital admission to hospital discharge, an overage of 1 month
To determine the incidence of SSI after CS at PCMH during the study period
3 secondary outcomes
Prevalence of Main Features
Time frame: From hospital admission to hospital discharge, an overage of 1 month
Prevalence of Negative Outcome
Time frame: From hospital admission to hospital discharge, an overage of 1 month
Screening of Risk factors
Time frame: From hospital admission to hospital discharge, an overage of 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Putoto, PhD principal investigator
Department of operational research Doctors with Africa CUAMM Padova, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection and Cesarean Section Complications, run by Doctors with Africa - CUAMM at 1 site in Sierra Leone.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sierra Leone. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Di Gennaro, MD (3924804707, cicciodigennaro@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence (time frame: From hospital admission to hospital discharge, an overage of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019.