Effect of Betadine Vaginal Cleansing Before Cesarean Section to Reduce Postoperative Infectious Morbidity

NCT07715409 — Not applicable, Not yet recruiting, 600 participants, Mohamed Mousa Mohamed Mousa

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Registry	NCT07715409
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, prevention
Enrollment	600 (Estimated)
Sponsor	Mohamed Mousa Mohamed Mousa (Other)
Conditions	Cesarean Section, Surgical Site Infection, Endometritis
Interventions	Povidone-iodine 5% solution (Drug)
Dates	start 2027-05-01 (estimated), primary completion 2027-05-01 (estimated), completion 2027-05-01 (estimated), first posted 2026-07-20, last updated 2026-07-20
Locations	1 site in Egypt

-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. The primary outcomes include wound-related complications, while secondary outcomes include postoperative fever, endometritis, wound infection, and white blood cell count.

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+Arms and interventions

Arm	Type	Interventions	Description
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.

Povidone-iodine 5% solution (Drug): Vaginal cleansing with 5% povidone-iodine for 30 seconds before cesarean section.

+Outcome measures

Primary outcomes

Incidence of postoperative wound-related complications Time Frame: Within 8 weeks after cesarean section [8 weeks]
Incidence of postoperative wound-related complications [Within 8 weeks after cesarean section]

Secondary outcomes

Postoperative fever (within 8 weeks) Postoperative WBC count (24 hours) Endometritis (within 8 weeks) Combined wound complications and endometritis [8 weeks]

+Eligibility

Sex: Female, accepts healthy volunteers

Inclusion Criteria:

\- Women undergoing elective or emergency cesarean section. Received prophylactic antibiotics before surgery

Exclusion Criteria:

* Active infection No prophylactic antibiotics Chorioamnionitis Placenta previa with antepartum hemorrhage

+Locations (1)

Facility	City	Country	Status
Al-Azhar University Hospital, Damietta	Damietta, Damietta Governorate	Egypt

+Investigators

ahmed shafik ibrahim, Study director, abdelrouf
ahmed shafik ibrahim, Study director