Prevention of Postpartum SepsisPhase 4NCT04792710
Kefazolin Versus Kefazolin Plus Metronidazole to Reduce Postpartum Infection
A Phase 4 study testing Metronidazole in people with Prevention of Postpartum Sepsis, run by University of Pretoria at 1 site in South Africa.
Trial summary
Randomised controlled trial to investigate the efficacy of adding metronidazole pre-operatively to kefazolin in reducing postpartum infection 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?
- Metronidazole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 1 siteSouth Africa
- Study dates
- 8 Mar 2021to 30 Jun 2022
- Phase
- Phase 4
- 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
- 18 years and older Willing and able to provide written informed consent
Who cannot join
- women younger than 18 years women not able or willing to provide written informed consent women with or without infection already receiving antibiotics for other indications women allergic to kefazolin or metronidazole
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Kalafong Provincial Tertiary Hospital
Pretoria, Gauteng
Leon c Snyman, PhD, +27834621818, leon.snyman@up.ac.za
Louisa Seopela, MMed (O&G), +27833014790, drseopela@yahoo.com
About this study
Official title: Randomised Trial Comparing Pre-operative Administration of Single Dose Kefazolin to Kefazolin Plus Metronidazole to Reduce Postpartum Infection
Randomised controlled trial to investigate the efficacy of adding metronidazole pre-operatively to kefazolin in reducing postpartum infection
Read the detailed description
All pregnant patients scheduled for emergency or elective Caesarean section ≥18 years, willing and able to provide informed consent and not receiving antibiotics, will be eligible for recruitment. Patients will be randomised into receiving kefazolin according to current standard of care administered pre-operatively intravenously with placebo (control arm), and kefazolin according to current standard of care administered pre-operatively with metronidazole 500 mg intravenously pre-operatively. Outcome measures will be surgical site infection, urinary tract infection and postpartum endometritis. Five hundred patients will be recruited in each arm
- Conditions
- Prevention of Postpartum Sepsis
- Being tested
- Metronidazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetronidazoleDrug
Also called Flagyl
Metronidazole 500 mg intravenous stat dose prior to skin incision
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | This arm will be allocated to receive metronidazole 500 mg in addition to the current standard of care (Kefazolin 1 or 2 grams) administered intravenously prior to skin incision at caesarean section as a once off dose Receives: Drug: Metronidazole |
| Control arm | Placebo comparator | This arm will be allocated to receive the current standard of care (Kefazolin 1 or 2 grams) administered intravenously prior to skin incision at caesarean section plus a placebo of normal saline 50 ml administered intravenously as a once off dose Receives: Drug: Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of reducing surgical site infection
Incidence of surgical site infections
Measured: Seven days post-operatively
Secondary outcomes (2)
Efficacy of reducing urinary tact infections
Incidence of urinary tract infections
Measured: Three days post-operatively
Efficacy of reducing postpartum endometritis
Incidence of endometritis
Measured: Seven days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start8 Mar 2021 (estimated)
- Primary completion31 Mar 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised placebo controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
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
- NCT04792710
- Sponsor's protocol ID
- PPS trial 1
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2021
- Last updated
- 11 Mar 2021
- Results posted
- No
- 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 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Trial Comparing Pre-operative Administration of Single Dose Kefazolin to Kefazolin Plus Metronidazole to Reduce Postpartum Infection
- ClinicalTrials.gov ID
- NCT04792710
- Acronym / sponsor ID
- PPS trial 1
- Conditions
- Prevention of Postpartum Sepsis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of PretoriaUniversity, hospital or other
- Study start
- 8 Mar 2021 (estimated)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 11 Mar 2021 (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 controlled trial to investigate the efficacy of adding metronidazole pre-operatively to kefazolin in reducing postpartum infection
Detailed description
All pregnant patients scheduled for emergency or elective Caesarean section ≥18 years, willing and able to provide informed consent and not receiving antibiotics, will be eligible for recruitment. Patients will be randomised into receiving kefazolin according to current standard of care administered pre-operatively intravenously with placebo (control arm), and kefazolin according to current standard of care administered pre-operatively with metronidazole 500 mg intravenously pre-operatively. Outcome measures will be surgical site infection, urinary tract infection and postpartum endometritis. Five hundred patients will be recruited in each arm
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised placebo controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Drug: MetronidazoleThis arm will be allocated to receive metronidazole 500 mg in addition to the current standard of care (Kefazolin 1 or 2 grams) administered intravenously prior to skin incision at caesarean section as a once off dose |
| Control arm | Placebo comparator | Drug: MetronidazoleThis arm will be allocated to receive the current standard of care (Kefazolin 1 or 2 grams) administered intravenously prior to skin incision at caesarean section plus a placebo of normal saline 50 ml administered intravenously as a once off dose |
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)
- 18 years and older Willing and able to provide written informed consent
Key exclusion criteria (1 listed)
- women younger than 18 years women not able or willing to provide written informed consent women with or without infection already receiving antibiotics for other indications women allergic to kefazolin or metronidazole
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 |
|---|---|---|
| MetronidazoleAlso: FlagylMetronidazole 500 mg intravenous stat dose prior to skin incision | Drug | Control arm, Intervention arm |
Primary outcome
Efficacy of reducing surgical site infection
Time frame: Seven days post-operatively
Incidence of surgical site infections
2 secondary outcomes
Efficacy of reducing urinary tact infections
Time frame: Three days post-operatively
Efficacy of reducing postpartum endometritis
Time frame: Seven days post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metronidazole 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: status not confirmed, as of the sponsor's last update on 11 Mar 2021. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leon C Snyman, PhD (+27834621818, leon.snyman@up.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of reducing surgical site infection (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 11 Mar 2021.