Surgical Site InfectionNCT03822039
WHO Checklist- Based Infection Prevention Guidelines in Mulago Hospital
An observational study of Surgical Site Infection, run by Makerere University at 1 site in Uganda.
Trial summary
This prospective cohort study will assess all mothers undergoing elective and emergency caesarean delivery in the labour ward theatre at Mulago National Referral Hospital based temporarily at Kawempe Hospital. Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Surgical Site Infection
- How many people
- 768 participants
- Where
- 1 siteUganda
- Study dates
- 16 Jul 2018to Feb 2019
- 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 15 years and older
- Women only
- Child, Adult, Older adult
Study population: Mothers undergoing Caesarean Deliveries in Mulago National Referral Hospital, Kawempe labour suite and gynaecology theatre.
Who may be able to join
- Mothers undergoing elective and emergency caesarean deliveries in Mulago National Referral Hospital, Kawempe in labour suite and gynaecology theatre.
Who cannot join
- Patient who is unconscious and unknown patient
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
Mulago hospital
Kampala, Mulago Hospital, 256
Ponsiano Ocama, PHD, 0772421190 ext. 256, Ponsiano.ocama@gmail.com
About this study
Official title: Compliance Levels With WHO Checklist-based Infection Prevention Guidelines and Associated Surgical Site Infection Following Caesarean Delivery in Mulago Hospital
This prospective cohort study will assess all mothers undergoing elective and emergency caesarean delivery in the labour ward theatre at Mulago National Referral Hospital based temporarily at Kawempe Hospital. Mothers will be recruited into the study systematically over a period of 3 months and follow-up daily until discharge or 30 days .
Read the detailed description
To determine the level of compliance with WHO checklist-based infection prevention guidelines following caesarean delivery in Mulago National Referral Hospital, Kawempe.
To determine the association between compliance with WHO checklist-based infection prevention guidelines and surgical site infection following caesarean delivery in Mulago Hospital, Kawempe.
This prospective cohort study will assess all mothers undergoing elective and emergency caesarean delivery in the labour ward theatre at Mulago National Referral Hospital based temporarily at Kawempe Hospital. Mothers will be recruited into the study systematically over a period of 3 months and follow-up daily until discharge or 30 days of in-hospital stay for the purpose of documentation of surgical site infection. Data will be collected using the checklist expansion for antisepsis and infection control questionnaire.
- Conditions
- Surgical Site Infection
- Medical subject headings
- Surgical Wound Infection
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of compliance with WHO checklist-based infection prevention guidelines following caesarean delivery among health care workers in Mulago Hospital, Kawempe
Using a tool of 12 parameters from the WHO Surgical Safety Checklist-based infection prevention standards, each of the parameters will be given a score of 1 if it was obeyed by the respondent and a score of 0 if it was omitted. Compliance will be then expressed as a percentage completion of the items comprising the checklist.
Measured: 24Hours
Secondary outcomes (1)
surgical site infection within 30 days of operation
Patients will be directly followed up during ward rounds until discharge and thereafter, telephone calls will be used every four days to enquire for development of surgical site infections such as fever, foul-smelling wound, redness around the incision, swelling/ induration at the wound site, burst wound.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start16 Jul 2018
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 768 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Mbiya, Mbchb, Principal investigator, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822039
- Sponsor's protocol ID
- 2018-085
- Status last verified
- Sep 2018
- First submitted
- 11 Sep 2018
- Last updated
- 30 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance Levels With WHO Checklist-based Infection Prevention Guidelines and Associated Surgical Site Infection Following Caesarean Delivery in Mulago Hospital
- ClinicalTrials.gov ID
- NCT03822039
- Acronym / sponsor ID
- 2018-085
- Conditions
- Surgical Site Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 768 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 30 Jan 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.
This prospective cohort study will assess all mothers undergoing elective and emergency caesarean delivery in the labour ward theatre at Mulago National Referral Hospital based temporarily at Kawempe Hospital. Mothers will be recruited into the study systematically over a period of 3 months and follow-up daily until discharge or 30 days .
Detailed description
To determine the level of compliance with WHO checklist-based infection prevention guidelines following caesarean delivery in Mulago National Referral Hospital, Kawempe.
To determine the association between compliance with WHO checklist-based infection prevention guidelines and surgical site infection following caesarean delivery in Mulago Hospital, Kawempe.
This prospective cohort study will assess all mothers undergoing elective and emergency caesarean delivery in the labour ward theatre at Mulago National Referral Hospital based temporarily at Kawempe Hospital. Mothers will be recruited into the study systematically over a period of 3 months and follow-up daily until discharge or 30 days of in-hospital stay for the purpose of documentation of surgical site infection. Data will be collected using the checklist expansion for antisepsis and infection control questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Mothers undergoing Caesarean Deliveries in Mulago National Referral Hospital, Kawempe labour suite and gynaecology theatre.
Key inclusion criteria (1 listed)
- Mothers undergoing elective and emergency caesarean deliveries in Mulago National Referral Hospital, Kawempe in labour suite and gynaecology theatre.
Key exclusion criteria (1 listed)
- Patient who is unconscious and unknown patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of compliance with WHO checklist-based infection prevention guidelines following caesarean delivery among health care workers in Mulago Hospital, Kawempe
Time frame: 24Hours
Using a tool of 12 parameters from the WHO Surgical Safety Checklist-based infection prevention standards, each of the parameters will be given a score of 1 if it was obeyed by the respondent and a score of 0 if it was omitted. Compliance will be then expressed as a percentage completion of the items comprising the checklist.
1 secondary outcome
surgical site infection within 30 days of operation
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Anne Mbiya, Mbchb principal investigator
Makerere University
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 Surgical Site Infection, run by Makerere University at 1 site in Uganda.
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 1 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 Jan 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 Uganda. 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 Anne Mbiya, Mbchb (0782423389 ext. 256, mbiyaanne2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of compliance with WHO checklist-based infection prevention guidelines following caesarean delivery among health care workers in Mulago Hospital, Kawempe (time frame: 24Hours). 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 Jan 2019.