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

Puerperal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03397615
• Other study ID #: 16
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2019
• Est. completion date: December 2019

Study information

• Verified date: July 2019
• Source: Cairo University
• Contact: Ahmed maged, MD
• Phone: +20201005227404
• Email: dr_ahmedmaged08[@]kasralainy.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Puerperal Infection

Intervention

Behavioral:
• Betadine douches
subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postpartum endometritis	a clinical diagnosis, usually involving fever, uterine fundal tenderness, or prurulent lochia requiring antibiotic therapy.	6 weeks after Cesarean section
Secondary	Postoperative wound infection	erythema, tenderness, prurulent drainage from the incision site, with or without fever, requiring antibiotic therapy	6 weeks after Cesarean section
Secondary	Postoperative fever	temperature higher than 38 degrees C	3 weeks after Cesarean section