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Efficacy of Using a Closing Pack to Reduce Postpartum Sepsis

NCT ID: NCT05632705

Last Updated: 2022-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-08

Study Completion Date

2022-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Prevention of Postpartum Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised trial
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
The outcomes assessor will not have information with regards to the intervention arms

Study Groups

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Intervention arm

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.

Group Type EXPERIMENTAL

Closing pack

Intervention Type OTHER

A closing pack, new sterile gloves and new sterile drapes will be used when commencing closure of the sheath and skin

Control arm

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Closing pack

A closing pack, new sterile gloves and new sterile drapes will be used when commencing closure of the sheath and skin

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Pretoria

OTHER

Sponsor Role lead

Responsible Party

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Leon Snyman

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kalafong Provincial Tertiary Hospital

Pretoria, Gauteng, South Africa

Site Status

Countries

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South Africa

Other Identifiers

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PPS trial 2

Identifier Type: -

Identifier Source: org_study_id