Preoperative Clindamycin Vaginal Cream Versus Vaginal Cleansing With Povidone-iodine on Postoperative Infections After Cesarean Section

NCT07474194 | Recruiting Phase 4 DMC

• 1 other identifier: FMBSUREC/07092025/Salama
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effects of preoperative prophylactic administration of clindamycin vaginal cream compared to preoperative vaginal cleansing using a 10% povidone-iodine solution on postpartum infectious morbidity.

Conditions

Infection Control / Methods; Surgical Site Infection (SSI)

Outcome Measures

Primary Outcomes (1)

• Wound infection (surgical site infection SSI)

  erythema, tenderness or wound edge separation with purulent discharge involving the cesarean incision site.

  3 weeks

Study Arms (3)

control

NO INTERVENTION

the control group has only prophylactic antibiotics according to hospital protocols.

Clindamycin vaginal cream

EXPERIMENTAL

Clindamycin vaginal cream one applicator each night for 3 nights before CS.

Drug: Clindamycin vaginal cream

Vaginal preparation with povidone- iodide solution 10 %

EXPERIMENTAL

Vaginal preparation with povidone- iodide solution 10 % before skin incision with sponge sticks prior to caesarean section.

Drug: Vaginal preparation with povidone- iodide solution 10 %

Interventions

Clindamycin vaginal cream DRUG

Clindamycin vaginal cream one applicator each night for 3 nights before CS.

Clindamycin vaginal cream

Vaginal preparation with povidone- iodide solution 10 % DRUG

Vaginal preparation with povidone- iodide solution 10 %

Vaginal preparation with povidone- iodide solution 10 %

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• female participants with singleton pregnancies scheduled for elective cesarean sections at term, specifically between 37 and 40 weeks of gestation
• free from any medical disorders.
• The participants' ages ranged from 18 to 40 years
• body mass index (BMI) ranged from 18 to 30 kg/m2

You may not qualify if:

• Cases of urgent or emergent CS.
• Abnormal vaginal secretion (bad smelling yellowish secretion, whitish cheesy discharge with pruritus, bloody discharge; etc…).
• Women with medical disorders such as pre-gestational diabetes, anemia, hypertension, preeclampsia, or immunosuppressant pregnant women.
• Women who had a skin infection adjacent to the operative site.
• Allergy to topical povidone-iodine or clindamycin
• Feverish patients or history of premature rupture of membranes or with placenta previa.
• patients lost during follow-up were excluded from the final analysis.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni suef university

Banī Suwayf, Egypt

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sara Abdallah Salem, MD

CONTACT

201272842226; sara.abdalla@med.bsu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of obstetrics and gynecology

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: September 20, 2025
• Primary Completion: April 30, 2026
• Study Completion: May 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

EG (1)