Cesarean SectionNCT07715409
Effect of Betadine Vaginal Cleansing Before Cesarean Section to Reduce Postoperative Infectious Morbidity
A study testing Povidone-iodine 5% solution in people with Cesarean Section and Surgical Site Infection, run by Mohamed Mousa Mohamed Mousa at 1 site in Egypt.
Trial summary
This randomized controlled trial aims to evaluate the efficacy of preoperative vaginal cleansing with 5% povidone-iodine in reducing postoperative infectious morbidity among women undergoing cesarean section. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section, Surgical Site Infection, Endometritis
- What is being tested?
- Povidone-iodine 5% solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2027to 1 May 2027
- Phase
- Interventional
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women undergoing elective or emergency cesarean section. Received prophylactic antibiotics before surgery
Who cannot join
- Active infection No prophylactic antibiotics Chorioamnionitis Placenta previa with antepartum hemorrhage
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
mohamed mousa Al-Azhar University Hospital, Damietta contact
mohamed mousa mohamed contact
Egypt1 site
Al-Azhar University Hospital, Damietta
Damietta, Damietta Governorate
About this study
This randomized controlled trial aims to evaluate the efficacy of preoperative vaginal cleansing with 5% povidone-iodine in reducing postoperative infectious morbidity among women undergoing cesarean section. The primary outcomes include wound-related complications, while secondary outcomes include postoperative fever, endometritis, wound infection, and white blood cell count.
- Conditions
- Cesarean Section, Surgical Site Infection, Endometritis
- Being tested
- Povidone-iodine 5% solution
- Medical subject headings
- Surgical Wound Infection, Endometritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone-iodine 5% solutionDrug
Vaginal cleansing with 5% povidone-iodine for 30 seconds before cesarean section.
| Study group | Role | What they receive |
|---|---|---|
| Betadine Vaginal Cleansing | Experimental | Not described Receives: Drug: Povidone-iodine 5% solution |
| No Vaginal Cleansing | No intervention | Participants will not receive preoperative vaginal cleansing before cesarean section. All other perioperative care, including prophylactic antibiotics and skin preparation, will be provided according to the hospital protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative wound-related complications Time Frame: Within 8 weeks after cesarean section
Measured: 8 weeks
Incidence of postoperative wound-related complications
Measured: Within 8 weeks after cesarean section
Secondary outcomes (1)
Postoperative fever (within 8 weeks) Postoperative WBC count (24 hours) Endometritis (within 8 weeks) Combined wound complications and endometritis
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 May 2027 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Mousa Mohamed Mousa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Mousa Mohamed Mousa, Al-Azhar University
- Investigators
- ahmed shafik ibrahim, Study director, abdelroufahmed shafik ibrahim, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715409
- Sponsor's protocol ID
- DFM-IRB 00012367-26-03-017
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: self limited
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Betadine Vaginal Cleansing Before Cesarean Section to Reduce Postoperative Infectious Morbidity
- ClinicalTrials.gov ID
- NCT07715409
- Acronym / sponsor ID
- DFM-IRB 00012367-26-03-017
- Conditions
- Cesarean Section, Surgical Site Infection, Endometritis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Mohamed Mousa Mohamed MousaUniversity, hospital or other
- Study start
- 1 May 2027 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 20 Jul 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.
This randomized controlled trial aims to evaluate the efficacy of preoperative vaginal cleansing with 5% povidone-iodine in reducing postoperative infectious morbidity among women undergoing cesarean section. The primary outcomes include wound-related complications, while secondary outcomes include postoperative fever, endometritis, wound infection, and white blood cell count.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Betadine Vaginal Cleansing | Experimental | Drug: Povidone-iodine 5% solution |
| No Vaginal Cleansing | No intervention | –Participants will not receive preoperative vaginal cleansing before cesarean section. All other perioperative care, including prophylactic antibiotics and skin preparation, will be provided according to the hospital protocol. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women undergoing elective or emergency cesarean section. Received prophylactic antibiotics before surgery
Key exclusion criteria (1 listed)
- Active infection No prophylactic antibiotics Chorioamnionitis Placenta previa with antepartum hemorrhage
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 |
|---|---|---|
| Povidone-iodine 5% solutionVaginal cleansing with 5% povidone-iodine for 30 seconds before cesarean section. | Drug | Betadine Vaginal Cleansing |
Primary outcome
Incidence of postoperative wound-related complications Time Frame: Within 8 weeks after cesarean section
Time frame: 8 weeks
Incidence of postoperative wound-related complications
Time frame: Within 8 weeks after cesarean section
1 secondary outcome
Postoperative fever (within 8 weeks) Postoperative WBC count (24 hours) Endometritis (within 8 weeks) Combined wound complications and endometritis
Time frame: 8 weeks
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 20 Jul 2026.
- Individual participant dataSharing planned: No. self limited
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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.
mohamed mousa Al-Azhar University Hospital, Damietta contact
mohamed mousa mohamed contact
ahmed shafik ibrahim study director
abdelrouf
ahmed shafik ibrahim study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Povidone-iodine 5% solution in people with Cesarean Section and Surgical Site Infection, run by Mohamed Mousa Mohamed Mousa 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 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: opening soon, as of the sponsor's last update on 20 Jul 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.
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 mohamed mousa Al-Azhar University Hospital, Damietta (2001021267963 ext. 2001092646269, mohamed.mousa.k0109@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative wound-related complications Time Frame: Within 8 weeks after cesarean section (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 20 Jul 2026.