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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorBeni-Suef University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 %

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: controlNo intervention 0 interventions
Group B: Clindamycin vaginal creamExperimental treatment 1 intervention
Group C: Vaginal preparation with povidone- iodide solution 10 %Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Wound infection (surgical site infection SSI)

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

Time frame
3 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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