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NCT Number: NCT07474194

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Beni suef university

Banī Suwayf, Egypt

Location status: Recruiting

Location contact

Sara Abdallah Salem, MD

CONTACT

[email protected]

201272842226

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Clindamycin vaginal cream

Drug

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

Vaginal preparation with povidone- iodide solution 10 %

Drug

Vaginal preparation with povidone- iodide solution 10 %

Primary outcomes

  1. Wound infection (surgical site infection SSI)

    Time frame: 3 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Abdallah Salem, MD

CONTACT

[email protected]

201272842226

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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

Acronym: SSI

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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