Infection Control / MethodsPhase 4SSINCT07474194
Preoperative Clindamycin Vaginal Cream Versus Vaginal Cleansing With Povidone-iodine on Postoperative Infections After Cesarean Section
A Phase 4 study testing Clindamycin vaginal cream and Vaginal preparation with povidone- iodide solution 10 % in people with Infection Control / Methods and Surgical Site Infection (SSI), run by Beni-Suef University at 1 site in Egypt.
Trial summary
To evaluate the effects of preoperative prophylactic administration of clindamycin vaginal cream compared to preoperative vaginal cleansing using a 10% povidone-iodine solution on postpartum infectious morbidity. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infection Control / Methods, Surgical Site Infection (SSI)
- What is being tested?
- Clindamycin vaginal cream and Vaginal preparation with povidone- iodide solution 10 %
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2025to 1 May 2026
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult
Who may be able to join
- female participants with singleton pregnancies scheduled for elective cesarean sections at term, specifically between 37 and 40 weeks of gestation
- free from any medical disorders.
- The participants' ages ranged from 18 to 40 years
- body mass index (BMI) ranged from 18 to 30 kg/m2
Who cannot join
- Cases of urgent or emergent CS.
- Abnormal vaginal secretion (bad smelling yellowish secretion, whitish cheesy discharge with pruritus, bloody discharge; etc…).
- Women with medical disorders such as pre-gestational diabetes, anemia, hypertension, preeclampsia, or immunosuppressant pregnant women.
- Women who had a skin infection adjacent to the operative site.
- Allergy to topical povidone-iodine or clindamycin
- Feverish patients or history of premature rupture of membranes or with placenta previa.
- patients lost during follow-up were excluded from the final analysis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Beni suef university
Banī Suwayf
Sara Abdallah Salem, MD, 201272842226, sara.abdalla@med.bsu.edu.eg
About this study
Official title: Comparative Study of the Effect of Preoperative Clindamycin Vaginal Cream Versus Vaginal Cleansing With Povidone-iodine on Postoperative Infections After Cesarean Section
To evaluate the effects of preoperative prophylactic administration of clindamycin vaginal cream compared to preoperative vaginal cleansing using a 10% povidone-iodine solution on postpartum infectious morbidity.
Read the detailed description
All patients (interventions and control group) are informed not to practice coitus, or use any vaginal products (such as douches, tampons or any type of pessary) during the period of intervention. Also, no vaginal examination was performed to all participants within 3 days of the CS.
The circulating nurse will clean the skin to all participants by following the manufacturer's guidelines.
The antiseptic (Povidone-Iodine) is opened, and the surgical site is scrubbed with it. A period of waiting for 3 min was allowed between the application of the antiseptic agent and skin incision to allow the adhesive surgical drapes to stick properly over dry skin.
The skin of all eligible individuals is aseptically treated in the same technique, using the same materials in an equal amount to control variances.
All the enrolled participants receive the same health education and wound care advice from the professional health team.
All participants will be given spinal anesthesia. Patients are catheterized with Foley's catheter no 16 F under complete aseptic conditions then abdominal scrub is performed as usual using povidone iodine. Pfannenstiel incision is performed as usual.
Transverse incision is performed in the lower uterine segment followed by delivery of the baby and the placenta and membrane.
Antibiotics are given according to hospital protocol (ceftriaxone 1gm and metronidazole iv /12 hours in first 24 hours starting within 1 hour from skin incision ) followed by Amoxicillin -clavulanic acid for 5 days after discharge Follow up after cesarean section
- All patients receive routine postoperative care without further interventions.
- All patients are advised to return to hospital if they develop symptoms of infections such as hotness of the body, foul smelling vaginal discharge, persistent/increasing lower abdominal pain, wound discharge, swelling, redness, or dehiscence
- Being tested
- Clindamycin vaginal cream, Vaginal preparation with povidone- iodide solution 10 %
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clindamycin vaginal creamDrug
Clindamycin vaginal cream one applicator each night for 3 nights before CS.
Vaginal preparation with povidone- iodide solution 10 %Drug
Vaginal preparation with povidone- iodide solution 10 %
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | the control group has only prophylactic antibiotics according to hospital protocols. |
| Clindamycin vaginal cream | Experimental | Clindamycin vaginal cream one applicator each night for 3 nights before CS. Receives: Drug: Clindamycin vaginal cream |
| Vaginal preparation with povidone- iodide solution 10 % | Experimental | Vaginal preparation with povidone- iodide solution 10 % before skin incision with sponge sticks prior to caesarean section. Receives: Drug: Vaginal preparation with povidone- iodide solution 10 % |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound infection (surgical site infection SSI)
erythema, tenderness or wound edge separation with purulent discharge involving the cesarean incision site.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start20 Sep 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection Control / MethodsStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Abdallah Mohamed Salem, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474194
- Sponsor's protocol ID
- FMBSUREC/07092025/Salama
- Acronym
- SSI
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Effect of Preoperative Clindamycin Vaginal Cream Versus Vaginal Cleansing With Povidone-iodine on Postoperative Infections After Cesarean Section
- ClinicalTrials.gov ID
- NCT07474194
- Acronym / sponsor ID
- SSI / FMBSUREC/07092025/Salama
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 16 Mar 2026 (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.
To evaluate the effects of preoperative prophylactic administration of clindamycin vaginal cream compared to preoperative vaginal cleansing using a 10% povidone-iodine solution on postpartum infectious morbidity.
Detailed description
All patients (interventions and control group) are informed not to practice coitus, or use any vaginal products (such as douches, tampons or any type of pessary) during the period of intervention. Also, no vaginal examination was performed to all participants within 3 days of the CS.
The circulating nurse will clean the skin to all participants by following the manufacturer's guidelines.
The antiseptic (Povidone-Iodine) is opened, and the surgical site is scrubbed with it. A period of waiting for 3 min was allowed between the application of the antiseptic agent and skin incision to allow the adhesive surgical drapes to stick properly over dry skin.
The skin of all eligible individuals is aseptically treated in the same technique, using the same materials in an equal amount to control variances.
All the enrolled participants receive the same health education and wound care advice from the professional health team.
All participants will be given spinal anesthesia. Patients are catheterized with Foley's catheter no 16 F under complete aseptic conditions then abdominal scrub is performed as usual using povidone iodine. Pfannenstiel incision is performed as usual.
Transverse incision is performed in the lower uterine segment followed by delivery of the baby and the placenta and membrane.
Antibiotics are given according to hospital protocol (ceftriaxone 1gm and metronidazole iv /12 hours in first 24 hours starting within 1 hour from skin incision ) followed by Amoxicillin -clavulanic acid for 5 days after discharge Follow up after cesarean section
- All patients receive routine postoperative care without further interventions.
- All patients are advised to return to hospital if they develop symptoms of infections such as hotness of the body, foul smelling vaginal discharge, persistent/increasing lower abdominal pain, wound discharge, swelling, redness, or dehiscence
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –the control group has only prophylactic antibiotics according to hospital protocols. |
| Clindamycin vaginal cream | Experimental | Drug: Clindamycin vaginal creamClindamycin vaginal cream one applicator each night for 3 nights before CS. |
| Vaginal preparation with povidone- iodide solution 10 % | Experimental | Drug: Vaginal preparation with povidone- iodide solution 10 %Vaginal preparation with povidone- iodide solution 10 % before skin incision with sponge sticks prior to caesarean section. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- female participants with singleton pregnancies scheduled for elective cesarean sections at term, specifically between 37 and 40 weeks of gestation
- free from any medical disorders.
- The participants' ages ranged from 18 to 40 years
- body mass index (BMI) ranged from 18 to 30 kg/m2
Key exclusion criteria (7 listed)
- Cases of urgent or emergent CS.
- Abnormal vaginal secretion (bad smelling yellowish secretion, whitish cheesy discharge with pruritus, bloody discharge; etc…).
- Women with medical disorders such as pre-gestational diabetes, anemia, hypertension, preeclampsia, or immunosuppressant pregnant women.
- Women who had a skin infection adjacent to the operative site.
- Allergy to topical povidone-iodine or clindamycin
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 |
|---|---|---|
| Clindamycin vaginal creamClindamycin vaginal cream one applicator each night for 3 nights before CS. | Drug | Clindamycin vaginal cream |
| Vaginal preparation with povidone- iodide solution 10 %Vaginal preparation with povidone- iodide solution 10 % | Drug | Vaginal preparation with povidone- iodide solution 10 % |
Primary outcome
Wound infection (surgical site infection SSI)
Time frame: 3 weeks
erythema, tenderness or wound edge separation with purulent discharge involving the cesarean incision site.
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 16 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Clindamycin vaginal cream and Vaginal preparation with povidone- iodide solution 10 % in people with Infection Control / Methods and Surgical Site Infection (SSI), run by Beni-Suef 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 16 Mar 2026. 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.
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?
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 Sara Abdallah Salem, MD (201272842226, sara.abdalla@med.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound infection (surgical site infection SSI) (time frame: 3 weeks). 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 16 Mar 2026.