NCT03822039

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
768

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 16, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

January 30, 2019

Status Verified

September 1, 2018

Enrollment Period

7 months

First QC Date

September 11, 2018

Last Update Submit

January 28, 2019

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • surgical site infection within 30 days of operation

    30 days

Eligibility Criteria

Age15 Years+
Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Mothers undergoing Caesarean Deliveries in Mulago National Referral Hospital, Kawempe labour suite and gynaecology theatre.

You may qualify if:

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

You may not qualify if:

  • Patient who is unconscious and unknown patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mulago hospital

Kampala, Mulago Hospital, 256, Uganda

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anne Mbiya, Mbchb

    Makerere University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Mbiya, Mbchb

CONTACT

0782423389mbiyaanne2@gmail.com

Ponsiano Ocama, Phd

CONTACT

0772421190ponsiano.ocama@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2018

First Posted

January 30, 2019

Study Start

July 16, 2018

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

January 30, 2019

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

UG(1)