NCT05632705

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

March 8, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed
Last Updated

November 30, 2022

Status Verified

November 1, 2022

Enrollment Period

11 months

First QC Date

March 8, 2021

Last Update Submit

November 21, 2022

Conditions

Prevention of Postpartum Sepsis

Outcome Measures

Primary Outcomes (1)

  • Efficacy to reduce surgical site infections within seven days

    Incidence of surgical site infections in both arms

    Seven days post-operatively

Secondary Outcomes (2)

  • Efficacy to reduce postpartum endometritis within seven days

    Seven days post-operatively

  • Feasibility of using a closure pack

    At the time of caesarean section

Study Arms (2)

Intervention arm

EXPERIMENTAL

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.

Other: Closing pack

Control arm

NO INTERVENTION

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

Interventions

Closing packOTHER

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

Intervention arm

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatients who are pregnant undergoing caesarean section
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women 18 years and older willing and able to provide consent

You may not qualify if:

  • women who are not able or willing to provide consent patients with existing maternal infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kalafong Provincial Tertiary Hospital

Pretoria, Gauteng, South Africa

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessor will not have information with regards to the intervention arms
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomised trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

March 8, 2021

First Posted

November 30, 2022

Study Start

March 8, 2021

Primary Completion

January 31, 2022

Study Completion

April 30, 2022

Last Updated

November 30, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

ZA(1)