Prevention of Postpartum SepsisNCT05632705
Efficacy of Using a Closing Pack to Reduce Postpartum Sepsis
A study testing Closing pack in people with Prevention of Postpartum Sepsis, run by University of Pretoria at 1 site in South Africa.
Trial summary
Randomised trial comparing the efficacy and feasibility of using a sterile closing pack to reduce postpartum sepsis Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prevention of Postpartum Sepsis
- What is being tested?
- Closing pack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteSouth Africa
- Study dates
- 8 Mar 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women 18 years and older willing and able to provide consent
Who cannot join
- women who are not able or willing to provide consent patients with existing maternal infection
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Kalafong Provincial Tertiary Hospital
Pretoria, Gauteng
About this study
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
Randomised trial comparing the efficacy and feasibility of using a sterile closing pack to reduce postpartum sepsis
Read the 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.
- Conditions
- Prevention of Postpartum Sepsis
- Being tested
- Closing pack
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closing packOther
A closing pack, new sterile gloves and new sterile drapes will be used when commencing closure of the sheath and skin
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Closing pack |
| Control arm | No intervention | In this arm sheath and skin closure will be according to the standard protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy to reduce surgical site infections within seven days
Incidence of surgical site infections in both arms
Measured: Seven days post-operatively
Secondary outcomes (2)
Efficacy to reduce postpartum endometritis within seven days
Incidence of postpartum endometritis in both arms
Measured: Seven days post-operatively
Feasibility of using a closure pack
Assess the availability as well as use of the sterile closing pack
Measured: At the time of caesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start8 Mar 2021
- Primary completion31 Jan 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Postpartum SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pretoria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leon Snyman, University of Pretoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632705
- Sponsor's protocol ID
- PPS trial 2
- Status last verified
- Nov 2022
- First submitted
- 8 Mar 2021
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05632705
- Acronym / sponsor ID
- PPS trial 2
- Conditions
- Prevention of Postpartum Sepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of PretoriaUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised trial
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Closing packIn this arm, prior to closing the sheath and skin, unused drapes, gloves and instruments will be used to close the sheath and the skin. |
| Control arm | No intervention | –In this arm sheath and skin closure will be according to the standard protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women 18 years and older willing and able to provide consent
Key exclusion criteria (1 listed)
- women who are not able or willing to provide consent patients with existing maternal infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closing packA closing pack, new sterile gloves and new sterile drapes will be used when commencing closure of the sheath and skin | Other | Intervention arm |
Primary outcome
Efficacy to reduce surgical site infections within seven days
Time frame: Seven days post-operatively
Incidence of surgical site infections in both arms
2 secondary outcomes
Efficacy to reduce postpartum endometritis within seven days
Time frame: Seven days post-operatively
Feasibility of using a closure pack
Time frame: At the time of caesarean section
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closing pack in people with Prevention of Postpartum Sepsis, run by University of Pretoria at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy to reduce surgical site infections within seven days (time frame: Seven days post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.