Clindamycin cream versus povidone-iodine vaginal cleansing to prevent infections after cesarean
Comparative Study of the Effect of Preoperative Clindamycin Vaginal Cream Versus Vaginal Cleansing With Povidone-iodine on Postoperative Infections After Cesarean Section
This compares clindamycin vaginal cream to 10% povidone-iodine vaginal cleansing before an elective cesarean to see if one prevents post‑operative infections better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Beni-Suef University Academic / other |
| Locations | 1 site (Banī Suwayf) |
| Trial ID | NCT07474194 on ClinicalTrials.gov |
What this trial studies
This Phase 4 interventional comparison enrolls healthy women having elective term (37–40 weeks) singleton cesarean deliveries and gives either preoperative clindamycin vaginal cream or a 10% povidone‑iodine vaginal wash. All participants receive the same skin antisepsis, spinal anesthesia, Foley catheterization, standard perioperative IV antibiotics (ceftriaxone and metronidazole), and uniform wound‑care instructions. Vaginal examinations and use of vaginal products are restricted within three days of surgery and the protocol standardizes timing and technique to limit variation. Postoperative infectious morbidity, including surgical site infections, is recorded during follow‑up.
Who should consider this trial
Good fit: Ideal candidates are healthy women aged 18–40 with singleton pregnancies at 37–40 weeks scheduled for elective cesarean with BMI 18–30 kg/m2 and no abnormal vaginal discharge or major medical conditions.
Not a fit: Patients with emergent cesareans, abnormal vaginal secretions, significant medical disorders, allergies to clindamycin or povidone‑iodine, fever, premature rupture of membranes, placenta previa, or those lost to follow‑up are unlikely to be eligible or benefit.
Why it matters
Potential benefit: If successful, this could reduce post‑cesarean infection rates, lower additional antibiotic use, and shorten recovery time.
How similar studies have performed: Previous trials of povidone‑iodine vaginal cleansing have shown mixed but sometimes positive effects on postpartum infection, while direct comparisons with topical clindamycin cream are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Banī Suwayf
- Beni suef university — Banī Suwayf, Egypt (Recruiting)
Study contacts
- Study coordinator: Sara Abdallah Salem, MD
- Email: sara.abdalla@med.bsu.edu.eg
- Phone: 201272842226
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.