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Not yet recruitingNCT07715409Updated Jul 20, 2026

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

An interventional study of Povidone-iodine 5% solution in Cesarean Section, Surgical Site Infection and Endometritis, sponsored by Mohamed Mousa Mohamed Mousa. Not yet recruiting at 1 site in Egypt. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-20.

Sponsored by Mohamed Mousa Mohamed Mousa · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Sex
Female
01

Study 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.

02

Conditions studied

  • Cesarean Section
  • Surgical Site Infection
  • Endometritis
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Active infection No prophylactic antibiotics Chorioamnionitis Placenta previa with antepartum hemorrhage
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    Betadine Vaginal Cleansing

    Drug: Povidone-iodine 5% solution

  • No intervention
    No Vaginal Cleansing

    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.

Interventions

  • DrugPovidone-iodine 5% solution

    Vaginal cleansing with 5% povidone-iodine for 30 seconds before cesarean section.

05

What researchers measure

Primary outcomes

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

    Time frame: 8 weeks

  2. Incidence of postoperative wound-related complications

    Time frame: 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

    Time frame: 8 weeks

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Study locations

1 site
  • Al-Azhar University Hospital, Damietta
    Damietta, Damietta Governorate, Egypt
07

References and documents

Individual participant data

Plan to share: No — self limited

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07715409
Lead sponsor
Mohamed Mousa Mohamed Mousa
Responsible party
Mohamed Mousa Mohamed Mousa (Resident of Obstetrics and Gynecology, Al-Azhar University Hospital, Damietta, Al-Azhar University) — Sponsor-investigator
First posted
Jul 20, 2026
Start date
May 1, 2027 (estimated)
Primary completion
May 1, 2027 (estimated)
Completion
May 1, 2027 (estimated)
Last update
Jul 20, 2026

Study contacts

mohamed mousa Al-Azhar University Hospital, Damietta
Contact
mohamed.mousa.k0109@gmail.com
2001021267963 ext. 2001092646269
mohamed mousa mohamed
Contact
ahmed shafik ibrahim
study director · abdelrouf
ahmed shafik ibrahim
study director

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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