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

NCT05021315 | Unknown Phase 3

• 1 other identifier: 82019
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 2

Brief Summary

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??

Conditions

Cesarean Section Complications; Vaginal Infection; Postoperative Infection

Outcome Measures

Primary Outcomes (1)

• Postoperative wound complication

  Any sign of infection as redness, hotness and tenderness as well as pyrexia occurance in wound postoperative

  1 week

Study Arms (2)

Iodine group

EXPERIMENTAL

50 women who received preoperative vaginal cleansing with 10% povidone-iodine.

Drug: 10% povidone iodine

Control group

NO INTERVENTION

50 women who did not receive preoperative vaginal cleansing even with tap water.

Interventions

10% povidone iodine DRUG

50 women who received preoperative vaginal cleansing with 10% povidone iodine.

Also known as: Betadine

Iodine group

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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.
• \. Pregnant women who are 37 weeks gestation or more with rupture of membranes but duration less than 24 hours
• \. Women consenting to be included in the study.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

faculty of medicine - Cairo university

Cairo, Kasr El Ainy, 11562, Egypt

RECRUITING

faculty of medicine, Kasr el ainy hospital, Cairo university

Cairo, 11562, Egypt

RECRUITING

MeSH Terms

Conditions

Vaginitis

Interventions

Povidone-Iodine

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Mostafa A Sleem, MD

  Ethical and scientific committee

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed A Taymour, MD

CONTACT

+201006588699; Mohammadtaymour@gmail.com

Waleed M El-Khayat, MD

CONTACT

01005135542; Waleed_elkhyat@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: August 25, 2021
• Study Start: September 15, 2021
• Primary Completion: September 30, 2022
• Study Completion: October 15, 2022
• Last Updated: July 18, 2022

Record last verified: 2022-07

Locations

EG (2)