Effect of Vaginal Douching With Betadine Before CS for Prevention of Post Operative Infections

Not Applicable

• Conditions: Puerperal Infection

• Registration Number: NCT03397615
• Lead Sponsor: Cairo University

Brief Summary

The present study was a prospective randomized controlled trial in which subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery or received no vaginal preparation

Detailed Description

The present study was a prospective randomized controlled trial in which subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery or received no vaginal preparation

Study Timeline

• Study First Submitted: 2018-01-06
• Study First Submitted QC: 2018-01-06
• Study First Posted: 2018-01-12
• Study Start: 2019-01-03
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-24
• Last Update Posted: 2019-07-26
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1200

Inclusion Criteria

• Any patient undergoing CS

Exclusion Criteria

• • Betadine allegy.

  • Rupture membranes.
  • Accidental Hemorrhage.
  • H/O suggestive chorioamnionitis ; uterine tenderness, offensive vaginal discharge, fever medical disorders as diabetes, hypertension , cardiac or renal diseqases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Postpartum endometritis	6 weeks after Cesarean section	a clinical diagnosis, usually involving fever, uterine fundal tenderness, or prurulent lochia requiring antibiotic therapy.

Secondary Outcome Measures

Name	Time	Method
Postoperative fever	3 weeks after Cesarean section	temperature higher than 38 degrees C
Postoperative wound infection	6 weeks after Cesarean section	erythema, tenderness, prurulent drainage from the incision site, with or without fever, requiring antibiotic therapy

Trial Locations

Locations (1)

Kasr Alainy medical school; 🇪🇬 Cairo, Egypt