Prevention of Postpartum Sepsis
Conditions
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.
Interventions
OTHERClosing pack
A closing pack, new sterile gloves and new sterile drapes will be used when commencing closure of the sheath and skin
Sponsors
University of Pretoria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessor will not have information with regards to the intervention arms
Intervention model description
Randomised trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy to reduce surgical site infections within seven days | Seven days post-operatively | Incidence of surgical site infections in both arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy to reduce postpartum endometritis within seven days | Seven days post-operatively | Incidence of postpartum endometritis in both arms |
| Feasibility of using a closure pack | At the time of caesarean section | Assess the availability as well as use of the sterile closing pack |
Countries
South Africa
Outcome results
None listed