NCT07715409

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
0mo left

Started May 2027

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2027

Expected
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

Same day

First QC Date

July 15, 2026

Last Update Submit

July 15, 2026

Conditions

Cesarean SectionSurgical Site InfectionEndometritis

Outcome Measures

Primary Outcomes (2)

  • 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 (1)

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

    8 weeks

Study Arms (2)

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.

Interventions

Povidone-iodine 5% solutionDRUG

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

Betadine Vaginal Cleansing

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen undergoing elective or emergency cesarean section.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University Hospital, Damietta

Damietta, Damietta Governorate, Egypt

Location

MeSH Terms

Conditions

Surgical Wound InfectionEndometritis

Interventions

Povidone-IodineSolutions

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic Inflammatory DiseaseAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUterine DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

IodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgriculturePharmaceutical Preparations

Study Officials

  • ahmed shafik ibrahim

    abdelrouf

    STUDY DIRECTOR

  • ahmed shafik ibrahim

    STUDY DIRECTOR

Central Study Contacts

mohamed mousa Al-Azhar University Hospital, Damietta

CONTACT

2001021267963mohamed.mousa.k0109@gmail.com

mohamed mousa mohamed

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Resident of Obstetrics and Gynecology, Al-Azhar University Hospital, Damietta

Study Record Dates

First Submitted

July 15, 2026

First Posted

July 20, 2026

Study Start (Estimated)

May 1, 2027

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

July 20, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

self limited

Locations

EG(1)