Site InfectionNCT06840041
Vaginal Microbiota and Post-cesarean SSI
An observational study of Site Infection and Cesarean Section; Complications, Wound, Infection (Following Delivery), run by Al-Azhar University at 1 site in Egypt.
Trial summary
The goal of this observational study is to investigate the relationship between vaginal microbiota composition and the development of post-cesarean section wound infection in women undergoing cesarean delivery. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Site Infection, Cesarean Section; Complications, Wound, Infection (Following Delivery)
- What is being tested?
- Vaginal swab and culture
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2025to 30 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: This study will enroll pregnant women undergoing either elective or emergency cesarean section at or beyond 37 weeks of gestation. Participants must have a singleton pregnancy. Women with known immunodeficiency, chronic infections, or those who have received antibiotics within two weeks prior to delivery will be excluded. Additionally, women with ruptured membranes for more than 18 hours will be excluded to minimize the potential influence of prolonged exposure to mixed flora. The study aims to investigate the relationship between vaginal microbiota and post-cesarean section wound infection within this defined population.
Who may be able to join
- Pregnant women undergoing elective or emergency cesarean section (CS).
- Singleton pregnancy.
- Cesarean section performed at ≥ 37 weeks of gestation.
Who cannot join
- Use of antibiotics within two weeks prior to delivery.
- Known immunodeficiency.
- Chronic infections.
- Ruptured membranes for more than 18 hours.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Relationship Between Vaginal Microbiota and Post-Cesarean Section Wound Infection
The goal of this observational study is to investigate the relationship between vaginal microbiota composition and the development of post-cesarean section wound infection in women undergoing cesarean delivery. The main question it aims to answer is:
Is there a correlation between specific vaginal microbiota profiles and the incidence of post-cesarean section wound infection? Can specific bacterial taxa or diversity indices within the vaginal microbiota predict the risk of post-cesarean section wound infection?
Read more
Participants will:
Provide vaginal swab samples pre-operatively and post-operatively. Undergo standard post-cesarean section care and follow-up. Have wound assessment performed per standard of care, and have data collected regarding wound infection status.
Have demographic and clinical data collected, including but not limited to, antibiotic use, gestational age, and comorbidities.
- Being tested
- Vaginal swab and culture
- Keywords
- cesarean section, SSI, vaginal microbiota
- Medical subject headings
- Wounds and Injuries, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal swab and cultureDiagnostic test
Participants will undergo vaginal swab collection both pre-operatively, immediately prior to the cesarean section, and post-operatively, within a defined timeframe after the procedure. The swabs will be collected using sterile swabs, following standardized procedures to ensure accurate sampling of the vaginal microbiota. The collected samples will then be sent to a designated laboratory for culture and analysis. This process will identify and characterize the bacterial composition of the vaginal microbiota, allowing researchers to investigate potential correlations between specific microbial profiles and the development of post-cesarean section wound infections
| Study group | Role | What they receive |
|---|---|---|
| cesarean section group | This observational study will enroll 160 women undergoing cesarean section. Participants will provide vaginal swab samples for culture, both pre-operatively and post-operatively. They will be monitored post-operatively for the development of wound infections, with wound assessments performed according to standard clinical practice. Demographic and clinical data, including antibiotic use, gestational age, and comorbidities, will be collected to assess the relationship between vaginal microbiota and post-cesarean wound infections. Receives: Diagnostic Test: Vaginal swab and culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Vaginal Microbiota Composition and Surgical Site Infection (SSI) Incidence
This outcome will assess the differences in vaginal microbiota composition between women who develop a surgical site infection (SSI) following cesarean section and those who do not. Microbiota composition will be determined through culture and analysis of vaginal swab samples collected pre-operatively and post-operatively. Comparisons will focus on identifying significant variations in bacterial taxa, diversity indices, and overall microbial community structure between the two groups.
Measured: 4 weeks after the surgery.
Secondary outcomes (1)
Predictive Value of Specific Vaginal Bacterial Species for Surgical Site Infection (SSI).
This outcome will evaluate the ability of specific bacterial species identified in vaginal swab samples to predict the development of surgical site infection (SSI) following cesarean section. Logistic regression analysis will be used to determine the independent predictive value of individual bacterial species, as well as combinations of species, for SSI. The analysis will assess the odds ratios, confidence intervals, and p-values associated with each bacterial species.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start30 Jun 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Site InfectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy, Al-Azhar University
- Investigators
- Muhamed Alhagrasy, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840041
- Sponsor's protocol ID
- Obst19225
- Status last verified
- Jun 2025
- First submitted
- 18 Feb 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified Individual Participant Data (IPD) that underlie the results reported in this article, including study protocol, statistical analysis plan, and analytic code, will be made available upon reasonable request to qualified researchers after publication. Requests should be submitted to MuhamedAhmed.216@azhar.edu.eg. Proposals will be reviewed by the Department of Obstetrics and Gynecology, Al-Azhar University to ensure that the proposed use of the data is scientifically sound and ethical. Data will be shared in a secure, password-protected format, and a data sharing agreement will be required to ensure responsible use and protection of participant confidentiality. The data will be available for 5 years following publication. Publication of results will be made without identifiers
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Vaginal Microbiota and Post-Cesarean Section Wound Infection
- ClinicalTrials.gov ID
- NCT06840041
- Acronym / sponsor ID
- Obst19225
- Keywords
- cesarean section, SSI, vaginal microbiota
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 21 Feb 2025 (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.
The goal of this observational study is to investigate the relationship between vaginal microbiota composition and the development of post-cesarean section wound infection in women undergoing cesarean delivery. The main question it aims to answer is:
Is there a correlation between specific vaginal microbiota profiles and the incidence of post-cesarean section wound infection? Can specific bacterial taxa or diversity indices within the vaginal microbiota predict the risk of post-cesarean section wound infection?
Participants will:
Provide vaginal swab samples pre-operatively and post-operatively. Undergo standard post-cesarean section care and follow-up. Have wound assessment performed per standard of care, and have data collected regarding wound infection status.
Have demographic and clinical data collected, including but not limited to, antibiotic use, gestational age, and comorbidities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cesarean section group | – | Diagnostic Test: Vaginal swab and cultureThis observational study will enroll 160 women undergoing cesarean section. Participants will provide vaginal swab samples for culture, both pre-operatively and post-operatively. They will be monitored post-operatively for the development of wound infections, with wound assessments performed according to standard clinical practice. Demographic and clinical data, including antibiotic use, gestational age, and comorbidities, will be collected to assess the relationship between vaginal microbiota and post-cesarean wound infections. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study will enroll pregnant women undergoing either elective or emergency cesarean section at or beyond 37 weeks of gestation. Participants must have a singleton pregnancy. Women with known immunodeficiency, chronic infections, or those who have received antibiotics within two weeks prior to delivery will be excluded. Additionally, women with ruptured membranes for more than 18 hours will be excluded to minimize the potential influence of prolonged exposure to mixed flora. The study aims to investigate the relationship between vaginal microbiota and post-cesarean section wound infection within this defined population.
Key inclusion criteria (3 listed)
- Pregnant women undergoing elective or emergency cesarean section (CS).
- Singleton pregnancy.
- Cesarean section performed at ≥ 37 weeks of gestation.
Key exclusion criteria (4 listed)
- Use of antibiotics within two weeks prior to delivery.
- Known immunodeficiency.
- Chronic infections.
- Ruptured membranes for more than 18 hours.
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 |
|---|---|---|
| Vaginal swab and cultureParticipants will undergo vaginal swab collection both pre-operatively, immediately prior to the cesarean section, and post-operatively, within a defined timeframe after the procedure. The swabs will be collected using sterile swabs, following standardized procedures to ensure accurate sampling of the vaginal microbiota. The collected samples will then be sent to a designated laboratory for culture and analysis. This process will identify and characterize the bacterial composition of the vaginal microbiota, allowing researchers to investigate potential correlations between specific microbial profiles and the development of post-cesarean section wound infections | Diagnostic test | cesarean section group |
Primary outcome
Comparison of Vaginal Microbiota Composition and Surgical Site Infection (SSI) Incidence
Time frame: 4 weeks after the surgery.
This outcome will assess the differences in vaginal microbiota composition between women who develop a surgical site infection (SSI) following cesarean section and those who do not. Microbiota composition will be determined through culture and analysis of vaginal swab samples collected pre-operatively and post-operatively. Comparisons will focus on identifying significant variations in bacterial taxa, diversity indices, and overall microbial community structure between the two groups.
1 secondary outcome
Predictive Value of Specific Vaginal Bacterial Species for Surgical Site Infection (SSI).
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: Yes. De-identified Individual Participant Data (IPD) that underlie the results reported in this article, including study protocol, statistical analysis plan, and analytic code, will be made available upon reasonable request to qualified researchers after publication. Requests should be submitted to MuhamedAhmed.216@azhar.edu.eg. Proposals will be reviewed by the Department of Obstetrics and Gynecology, Al-Azhar University to ensure that the proposed use of the data is scientifically sound and ethical. Data will be shared in a secure, password-protected format, and a data sharing agreement will be required to ensure responsible use and protection of participant confidentiality. The data will be available for 5 years following publication. Publication of results will be made without identifiers
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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.
Muhamed Alhagrasy principal investigator
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Site Infection and Cesarean Section; Complications, Wound, Infection (Following Delivery), run by Al-Azhar University at 1 site in Egypt.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 15 Jun 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhamed Alhagrasy, M.D. (01017313413, MuhamedAhmed.216@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Vaginal Microbiota Composition and Surgical Site Infection (SSI) Incidence (time frame: 4 weeks after the surgery.). 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 15 Jun 2025.