Vaginal Cleaning Using Povidone Iodine Before CS to Reduce Postoperative Wound Infection

Effect of Vaginal Cleaning Using Povidone Iodine Before CS to Reduce Postoperative Wound Infection

The aim of work to assess the effectiveness of preoperative vaginal cleansing with povidone iodine on reduction of post caesarean section wound infection

Research questions:

Does vaginal cleaning using povidone iodine before cesarean section has effect on reduction of postoperative wound infection??

Study Overview

• Status: Recruiting
• Conditions: Postoperative Infection; Cesarean Section Complications; Vaginal Infection
• Intervention / Treatment: Drug: 10% povidone iodine

• Study Type: Interventional
• Enrollment (Anticipated): 800
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mohammed A Taymour, MD; Phone Number: +201006588699; Email: Mohammadtaymour@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Recruiting
    • faculty of medicine, Kasr el ainy hospital, Cairo university
    • Contact: Mohammad A Taymour, MD
  • Kasr El Ainy
    • Cairo, Kasr El Ainy, Egypt, 11562
      • Recruiting
      • Faculty of Medicine - Cairo University
      • Contact: mohamed T aneis, MD; Phone Number: 202 23653269; Email: viced.research@cu.edu.eg
      • Principal Investigator: waleed M El-khayat, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 1. Pregnant women who are 37 weeks gestation or more scheduled for elective cesarean section or those in labor with a limited number of vaginal examinations less than 5 times preoperatively.

  2. Pregnant women who are 37 weeks gestation or more with rupture of membranes but duration less than 24 hours

  3. Women consenting to be included in the study.

Exclusion criteria:

1. Abnormally invasive placenta and placenta previa.
2. Intra-partum fever.
3. Prolonged rupture of membranes more than 24 hours
4. History of exposure to radiation treatment for cancer.
5. History of Gynecological infections (PID).
6. History of abdominal infections, e.g., peritonitis.
7. Debilitating diseases like Diabetes mellitus, Thyroid disorders, Cushing disease, abdominal malignancy.
8. Obesity is defined as pregnant BMI >30 kg/m2.
9. History of wound infection or burst abdomen.
10. History suggestive of massive bleeding during previous cesarean section.
11. allergy to iodine-containing solutions
12. Pregnant women with severe anemia defined as Hb <7 g/dl.
13. Cases with intra-abdominal drain deployment are discarded.
14. Obstructed labor with numerous vaginal examinations.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Iodine group; 50 women who received preoperative vaginal cleansing with 10% povidone-iodine.	Drug: 10% povidone iodine; 50 women who received preoperative vaginal cleansing with 10% povidone iodine.; Other Names: Betadine
NO_INTERVENTION: Control group; 50 women who did not receive preoperative vaginal cleansing even with tap water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative wound complication	Any sign of infection as redness, hotness and tenderness as well as pyrexia occurance in wound postoperative	1 week

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Mostafa A Sleem, MD, Ethical and scientific committee

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 15, 2021
• Primary Completion (ANTICIPATED): September 30, 2022
• Study Completion (ANTICIPATED): October 15, 2022

Study Registration Dates

• First Submitted: August 20, 2021
• First Submitted That Met QC Criteria: August 20, 2021
• First Posted (ACTUAL): August 25, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Infections; Communicable Diseases; Surgical Wound Infection; Wound Infection; Anti-Infective Agents, Local; Anti-Infective Agents; Plasma Substitutes; Blood Substitutes; Povidone-Iodine; Povidone
• Other Study ID Numbers: 82019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No