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Chlorhexidine Vaginal Cleansing Versus Iodine Prior to C-section and the Rate of Postoperative Infection

Primary Purpose

Vaginal Scrubbing

Status
Completed
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Chlorhexidine
Iodine
Antibiotics
Sponsored by
Makassed General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Vaginal Scrubbing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • all pregnant women who will undergo cesarean delivery
  • and willing to sign the informed consent.

Exclusion Criteria:

  • Known allergy to the antiseptics used
  • Infection diagnosis on admission
  • Age ≤ 17 years

Sites / Locations

  • Makassed General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group chlorhexidine

Group iodine

Arm Description

Patients will receive chlorhexidine abdominal and vaginal scrubbing

Patients will receive iodine abdominal and vaginal scrubbing

Outcomes

Primary Outcome Measures

Infectious morbidities
post cesarean infectious morbidities: endometritis, febrile morbidity and wound infection

Secondary Outcome Measures

Length of hospital stay
Length of hospital stay after delivery
Readmission to the hospital
Percentage of patients readmitted to the hospital

Full Information

First Posted
February 5, 2018
Last Updated
September 26, 2019
Sponsor
Makassed General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03431701
Brief Title
Chlorhexidine Vaginal Cleansing Versus Iodine Prior to C-section and the Rate of Postoperative Infection
Official Title
Chlorhexidine Vaginal Cleansing Versus Iodine Prior to C-section and the Rate of Postoperative Infection: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 8, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Makassed General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Background: Women undergoing cesarean delivery have 5 to 20 fold greater risk for infection and infectious morbidity compared with those undergoing vaginal birth. Endometritis, febrile morbidity, and wound infection are the most frequent complications of post cesarean infections. Endometritis accounts for 6-27% followed by clinically significant fever, which was reported about 5-24%,while the incidence of wound infection is about 2-9%.Previous studies evaluated whether vaginal cleansing can reduce the incidence of postoperative infectious morbidity. In most of the studies, povidone iodine was used as intervention. Objectives: The aim of this study is to test the hypothesis that preoperative vaginal cleansing with chlorhexidine would be superior to iodine for the prevention of maternal infectious morbidities including endometritis, fever and wound complications. Methods: This prospective randomized single blinded controlled trial will be conducted at Makassed General Hospital between February 2018 and January 2019. Total of 300 patients, 150 in each group, will be enrolled. Group 1 patients will receive chlorhexidine vaginal cleansing while group 2 patients will receive iodine prior to C-section. Adverse post infectious morbidities such as endometritis, febrile illness and wound infections will be observed within 30 days of C-section.
Detailed Description
This prospective randomized single blinded controlled trial will be conducted at Makassed General Hospital between February 2018 and January 2019. All pregnant women who will undergo cesarean delivery and willing to sign the informed consent will be included. Total of 300 patients, 150 in each group, will be enrolled. Group 1 patients will receive chlorhexidine vaginal cleansing while group 2 patients will receive iodine prior to C-section. Adverse post infectious morbidities such as endometritis, febrile illness and wound infections will be observed d within 30 days of C-section. Vaginal cleansing will be performed in conjunction with the abdominal preparation with foam sponge that contains either chlorhexidine or iodine, sponge will be inserted into the vagina and rotated 360 degrees in the vaginal cavity for about 30 sec. All participants will receive a single body mass index (BMI) based antibiotic dose of cefazolin within 30 minutes prior to the incision.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
333 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group chlorhexidine
Arm Type
Experimental
Arm Description
Patients will receive chlorhexidine abdominal and vaginal scrubbing
Arm Title
Group iodine
Arm Type
Active Comparator
Arm Description
Patients will receive iodine abdominal and vaginal scrubbing
Intervention Type
Other
Intervention Name(s)
Chlorhexidine
Intervention Description
Vaginal cleansing will be performed in conjunction with the abdominal preparation with foam sponge that contains chlorhexidine. A sponge soaked with chlorhexidine will be inserted into the vagina and rotated 360 degrees in the vaginal cavity for about 30 seconds
Intervention Type
Other
Intervention Name(s)
Iodine
Intervention Description
Vaginal cleansing will be performed in conjunction with the abdominal preparation with foam sponge that contains iodine. A sponge soaked with iodine will be inserted into the vagina and rotated 360 degrees in the vaginal cavity for about 30 seconds
Intervention Type
Other
Intervention Name(s)
Antibiotics
Intervention Description
All participants will receive a single body mass index (BMI) based antibiotic dose of cefazolin or clindamycin within 30 minutes prior to the incision.
Primary Outcome Measure Information:
Title
Infectious morbidities
Description
post cesarean infectious morbidities: endometritis, febrile morbidity and wound infection
Time Frame
Within 30 days
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
Length of hospital stay after delivery
Time Frame
Within 30 days
Title
Readmission to the hospital
Description
Percentage of patients readmitted to the hospital
Time Frame
Within 30 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all pregnant women who will undergo cesarean delivery and willing to sign the informed consent. Exclusion Criteria: Known allergy to the antiseptics used Infection diagnosis on admission Age ≤ 17 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manal Hubesih, MD
Organizational Affiliation
Makassed General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Makassed General Hospital
City
Beirut
Country
Lebanon

12. IPD Sharing Statement

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Chlorhexidine Vaginal Cleansing Versus Iodine Prior to C-section and the Rate of Postoperative Infection

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