Back to resultsEfficacy of Using a Closing Pack to Reduce Postpartum Sepsis
Primary Purpose
Prevention of Postpartum Sepsis
Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Closing pack
Sponsored by
About this trial
This is an interventional prevention trial for Prevention of Postpartum Sepsis
Eligibility Criteria
Inclusion Criteria: women 18 years and older willing and able to provide consent Exclusion Criteria: women who are not able or willing to provide consent patients with existing maternal infection
Sites / Locations
- Kalafong Provincial Tertiary Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention arm
Control arm
Arm Description
In this arm, prior to closing the sheath and skin, unused drapes, gloves and instruments will be used to close the sheath and the skin.
In this arm sheath and skin closure will be according to the standard protocol
Outcomes
Primary Outcome Measures
Efficacy to reduce surgical site infections within seven days
Incidence of surgical site infections in both arms
Secondary Outcome Measures
Efficacy to reduce postpartum endometritis within seven days
Incidence of postpartum endometritis in both arms
Feasibility of using a closure pack
Assess the availability as well as use of the sterile closing pack
Full Information
NCT ID
NCT05632705
First Posted
March 8, 2021
Last Updated
November 21, 2022
Sponsor
University of Pretoria
1. Study Identification
Unique Protocol Identification Number
NCT05632705
Brief Title
Efficacy of Using a Closing Pack to Reduce Postpartum Sepsis
Official Title
A Randomised Trial to Evaluate the Efficacy and Feasibility of a Closing Pack to Reduce the Rate of Surgical Site Infection Following Caesarean Section
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pretoria
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Randomised trial comparing the efficacy and feasibility of using a sterile closing pack to reduce postpartum sepsis
Detailed Description
Pregnant patients meeting the inclusion criteria undergoing elective or emergency caesarean section will be eligible for recruitment. Patients will be randomised into two arms. In the control arm sheath and skin closure will be performed with the instruments used to perform the caesarean section, as per the current standard of care. In the intervention arm, after suturing the uterine incision and obtaining hemostasis and before commencing closure of the sheath and skin, the surgical team (obstetrician, assistant and scrub sister) will don clean sterile gloves, open clean sterile linen to drape on top of the existing linen and open a pack of clean sterile instruments to close the sheath and skin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of Postpartum Sepsis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised trial
Masking
Outcomes Assessor
Masking Description
The outcomes assessor will not have information with regards to the intervention arms
Allocation
Randomized
Enrollment
1000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
In this arm, prior to closing the sheath and skin, unused drapes, gloves and instruments will be used to close the sheath and the skin.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
In this arm sheath and skin closure will be according to the standard protocol
Intervention Type
Other
Intervention Name(s)
Closing pack
Intervention Description
A closing pack, new sterile gloves and new sterile drapes will be used when commencing closure of the sheath and skin
Primary Outcome Measure Information:
Title
Efficacy to reduce surgical site infections within seven days
Description
Incidence of surgical site infections in both arms
Time Frame
Seven days post-operatively
Secondary Outcome Measure Information:
Title
Efficacy to reduce postpartum endometritis within seven days
Description
Incidence of postpartum endometritis in both arms
Time Frame
Seven days post-operatively
Title
Feasibility of using a closure pack
Description
Assess the availability as well as use of the sterile closing pack
Time Frame
At the time of caesarean section
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Patients who are pregnant undergoing caesarean section
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women 18 years and older willing and able to provide consent
Exclusion Criteria:
women who are not able or willing to provide consent patients with existing maternal infection
Facility Information:
Facility Name
Kalafong Provincial Tertiary Hospital
City
Pretoria
State/Province
Gauteng Province
Country
South Africa
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Using a Closing Pack to Reduce Postpartum Sepsis
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