Back to results

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

Primary Purpose

Cesarean Section Complications, Vaginal Infection, Postoperative Infection

Status

Recruiting

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

10% povidone iodine

About this trial

This is an interventional prevention trial for Cesarean Section Complications

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

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:

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.

Sites / Locations

faculty of medicine - Cairo universityRecruiting
faculty of medicine, Kasr el ainy hospital, Cairo universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Iodine group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Postoperative wound complication

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05021315

First Posted

August 20, 2021

Last Updated

July 14, 2022

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT05021315

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 15, 2021 (Actual)

Primary Completion Date

September 30, 2022 (Anticipated)

Study Completion Date

October 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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??

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cesarean Section Complications, Vaginal Infection, Postoperative Infection

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Iodine group

Arm Type

Experimental

Arm Description

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

Arm Title

Control group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

10% povidone iodine

Other Intervention Name(s)

Betadine

Intervention Description

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

Primary Outcome Measure Information:

Title

Postoperative wound complication

Description

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

Time Frame

1 week

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

38 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohammed A Taymour, MD

Phone

+201006588699

Mohammadtaymour@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Waleed M El-Khayat, MD

Phone

01005135542

Waleed_elkhyat@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mostafa A Sleem, MD

Organizational Affiliation

Ethical and scientific committee

Official's Role

Principal Investigator

Facility Information:

Facility Name

faculty of medicine - Cairo university

City

Cairo

State/Province

Kasr El Ainy

ZIP/Postal Code

11562

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

mohamed T aneis, MD

Phone

202 23653269

viced.research@cu.edu.eg

First Name & Middle Initial & Last Name & Degree

waleed M El-khayat, MD

Facility Name

faculty of medicine, Kasr el ainy hospital, Cairo university

City

Cairo

ZIP/Postal Code

11562

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mohammad A Taymour, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs