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

July 15, 2026 updated by: Mohamed Mousa Mohamed Mousa
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: mohamed mousa mohamed

Study Locations

  • Egypt
    • Damietta Governorate
      • Damietta, Damietta Governorate, Egypt
        • Al-Azhar University Hospital, Damietta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Betadine Vaginal Cleansing
Drug: Povidone-iodine 5% solution
Vaginal cleansing with 5% povidone-iodine for 30 seconds before cesarean section.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative fever (within 8 weeks) Postoperative WBC count (24 hours) Endometritis (within 8 weeks) Combined wound complications and endometritis
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohamed Mousa Mohamed Mousa

Investigators

  • Study Director: ahmed shafik ibrahim, abdelrouf
  • Study Director: ahmed shafik ibrahim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2027

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

July 15, 2026

First Submitted That Met QC Criteria

July 15, 2026

First Posted (Actual)

July 20, 2026

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 15, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DFM-IRB 00012367-26-03-017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

self limited

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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