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

Comparative Study of the Effect of Preoperative Clindamycin Vaginal Cream Versus Vaginal Cleansing With Povidone-iodine on Postoperative Infections After Cesarean Section

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.

Study Overview

• Status: Recruiting
• Conditions: Infection Control / Methods; Surgical Site Infection (SSI)
• Intervention / Treatment: Drug: Clindamycin vaginal cream; Drug: Vaginal preparation with povidone- iodide solution 10 %

Detailed Description

All patients (interventions and control group) are informed not to practice coitus, or use any vaginal products (such as douches, tampons or any type of pessary) during the period of intervention. Also, no vaginal examination was performed to all participants within 3 days of the CS.

The circulating nurse will clean the skin to all participants by following the manufacturer's guidelines.

The antiseptic (Povidone-Iodine) is opened, and the surgical site is scrubbed with it. A period of waiting for 3 min was allowed between the application of the antiseptic agent and skin incision to allow the adhesive surgical drapes to stick properly over dry skin.

The skin of all eligible individuals is aseptically treated in the same technique, using the same materials in an equal amount to control variances.

All the enrolled participants receive the same health education and wound care advice from the professional health team.

All participants will be given spinal anesthesia. Patients are catheterized with Foley's catheter no 16 F under complete aseptic conditions then abdominal scrub is performed as usual using povidone iodine. Pfannenstiel incision is performed as usual.

Transverse incision is performed in the lower uterine segment followed by delivery of the baby and the placenta and membrane.

Antibiotics are given according to hospital protocol (ceftriaxone 1gm and metronidazole iv /12 hours in first 24 hours starting within 1 hour from skin incision ) followed by Amoxicillin -clavulanic acid for 5 days after discharge Follow up after cesarean section

• All patients receive routine postoperative care without further interventions.
• All patients are advised to return to hospital if they develop symptoms of infections such as hotness of the body, foul smelling vaginal discharge, persistent/increasing lower abdominal pain, wound discharge, swelling, redness, or dehiscence

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sara Abdallah Salem, MD; Phone Number: 201272842226; Email: sara.abdalla@med.bsu.edu.eg

Study Locations

• Egypt
  • Banī Suwayf, Egypt
    • Recruiting
    • Beni suef university
    • Contact: Sara Abdallah Salem, MD; Phone Number: 201272842226; Email: sara.abdalla@med.bsu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control; the control group has only prophylactic antibiotics according to hospital protocols.
Experimental: Clindamycin vaginal cream; Clindamycin vaginal cream one applicator each night for 3 nights before CS.	Drug: Clindamycin vaginal cream; Clindamycin vaginal cream one applicator each night for 3 nights before CS.
Experimental: Vaginal preparation with povidone- iodide solution 10 %; 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 %; Vaginal preparation with povidone- iodide solution 10 %

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound infection (surgical site infection SSI)	erythema, tenderness or wound edge separation with purulent discharge involving the cesarean incision site.	3 weeks

Collaborators and Investigators

• Sponsor: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2025
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: March 11, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Infections; Wound Infection; Pathological Conditions, Signs and Symptoms; Surgical Wound Infection
• Other Study ID Numbers: FMBSUREC/07092025/Salama

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No