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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03822039
Other study ID # 2018-085
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 16, 2018
Est. completion date February 2019

Study information

Verified date September 2018
Source Makerere University
Contact Anne Mbiya, Mbchb
Phone 0782423389
Email mbiyaanne2@gmail.com
Is FDA regulated No
Health authority
Study type Observational

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 768
Est. completion date February 2019
Est. primary completion date February 2019
Accepts healthy volunteers
Gender Female
Age group 15 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Uganda Mulago hospital Kampala Mulago Hospital

Sponsors (1)

Lead Sponsor Collaborator
Makerere University

Country where clinical trial is conducted

Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 24Hours
Secondary 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. 30 days
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