Efficacy of Using a Closing Pack to Reduce Postpartum Sepsis

University of Pretoria (UP)

Status: Completed

Conditions: Prevention of Postpartum Sepsis

Treatments: Other: Closing pack

Study type: Interventional

Funder types: Other

Identifiers

NCT05632705

PPS trial 2

Details and patient eligibility

About

Randomised trial comparing the efficacy and feasibility of using a sterile closing pack to reduce postpartum sepsis

Full 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.

Enrollment: 1,000 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 2 patient groups

Intervention arm

Experimental group

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.

Treatment:

Other: Closing pack

Control arm

No Intervention group

Description:

In this arm sheath and skin closure will be according to the standard protocol