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WHO Checklist- Based Infection Prevention Guidelines in Mulago Hospital

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ClinicalTrials.gov Identifier: NCT03822039
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Makerere University

Brief 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. Mothers will be recruited into the study systematically over a period of 3 months and follow-up daily until discharge or 30 days .

Condition or disease
Surgical Site Infection

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.


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Study Type : Observational
Estimated Enrollment : 768 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Compliance Levels With WHO Checklist-based Infection Prevention Guidelines and Associated Surgical Site Infection Following Caesarean Delivery in Mulago Hospital
Actual Study Start Date : July 16, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. surgical site infection within 30 days of operation [ Time Frame: 30 days ]
    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.



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Probability Sample
Study Population
Mothers undergoing Caesarean Deliveries in Mulago National Referral Hospital, Kawempe labour suite and gynaecology theatre.
Criteria

Inclusion Criteria:

  • Mothers undergoing elective and emergency caesarean deliveries in Mulago National Referral Hospital, Kawempe in labour suite and gynaecology theatre.

Exclusion Criteria:

  • Patient who is unconscious and unknown patient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03822039


Contacts
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Contact: Anne Mbiya, Mbchb 0782423389 ext 256 mbiyaanne2@gmail.com
Contact: Ponsiano Ocama, Phd 0772421190 ext 256 ponsiano.ocama@gmail.com

Locations
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Uganda
Mulago hospital Recruiting
Kampala, Mulago Hospital, Uganda, 256
Contact: Ponsiano Ocama, PHD    0772421190 ext 256    Ponsiano.ocama@gmail.com   
Sponsors and Collaborators
Makerere University
Investigators
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Principal Investigator: Anne Mbiya, Mbchb Makerere University

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Responsible Party: Makerere University
ClinicalTrials.gov Identifier: NCT03822039     History of Changes
Other Study ID Numbers: 2018-085
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes