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

• ClinicalTrials.gov Identifier: NCT03431701
• Recruitment Status: Completed
• First Posted: February 13, 2018
• Last Update Posted: September 27, 2019
• Sponsor: Makassed General Hospital
• Information provided by (Responsible Party): Manal Hubeish, Makassed General Hospital

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.

Condition or disease	Intervention/treatment	Phase
Vaginal Scrubbing	Other: Chlorhexidine; Other: Iodine; Other: Antibiotics	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 333 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Chlorhexidine Vaginal Cleansing Versus Iodine Prior to C-section and the Rate of Postoperative Infection: Randomized Clinical Trial
• Actual Study Start Date: February 8, 2018
• Actual Primary Completion Date: June 30, 2019
• Actual Study Completion Date: June 30, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group chlorhexidine; Patients will receive chlorhexidine abdominal and vaginal scrubbing	Other: Chlorhexidine; 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; Other: Antibiotics; All participants will receive a single body mass index (BMI) based antibiotic dose of cefazolin or clindamycin within 30 minutes prior to the incision.
Active Comparator: Group iodine; Patients will receive iodine abdominal and vaginal scrubbing	Other: Iodine; 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; Other: Antibiotics; All participants will receive a single body mass index (BMI) based antibiotic dose of cefazolin or clindamycin within 30 minutes prior to the incision.

Outcome Measures

Primary Outcome Measures :

1. Infectious morbidities [ Time Frame: Within 30 days ]
   post cesarean infectious morbidities: endometritis, febrile morbidity and wound infection

Secondary Outcome Measures :

1. Length of hospital stay [ Time Frame: Within 30 days ]
   Length of hospital stay after delivery
2. Readmission to the hospital [ Time Frame: Within 30 days ]
   Percentage of patients readmitted to the hospital

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Lebanon

Makassed General Hospital

Beirut, Lebanon

Sponsors and Collaborators

Makassed General Hospital

Investigators

• Principal Investigator: Manal Hubesih, MD; Makassed General Hospital

More Information

• Responsible Party: Manal Hubeish, OBGYN attending physician, Makassed General Hospital
• ClinicalTrials.gov Identifier: NCT03431701
• Other Study ID Numbers: 01022018
• First Posted: February 13, 2018
• Last Update Posted: September 27, 2019
• Last Verified: September 2019

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

Additional relevant MeSH terms:

Infections; Anti-Bacterial Agents; Chlorhexidine; Anti-Infective Agents; Anti-Infective Agents, Local; Disinfectants