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

NCT03431701 | Completed

• 1 other identifier: 01022018
• Study Type: interventional
• Target: 333
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Scrubbing

Outcome Measures

Primary Outcomes (1)

• Infectious morbidities

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

  Within 30 days

Secondary Outcomes (2)

• Length of hospital stay

  Within 30 days

• Readmission to the hospital

  Within 30 days

Study Arms (2)

Group chlorhexidine

EXPERIMENTAL

Patients will receive chlorhexidine abdominal and vaginal scrubbing

Other: Chlorhexidine; Other: Antibiotics

Group iodine

ACTIVE COMPARATOR

Patients will receive iodine abdominal and vaginal scrubbing

Other: Iodine; Other: Antibiotics

Interventions

Chlorhexidine OTHER

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

Group chlorhexidine

Iodine OTHER

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

Group iodine

Antibiotics OTHER

All participants will receive a single body mass index (BMI) based antibiotic dose of cefazolin or clindamycin within 30 minutes prior to the incision.

Group chlorhexidine; Group iodine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Makassed General Hospital: lead

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

Location

MeSH Terms

Interventions

Chlorhexidine; Iodine; Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Halogens; Elements; Inorganic Chemicals; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Manal Hubesih, MD

  Makassed General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: OBGYN attending physician

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 13, 2018
• Study Start: February 8, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: September 27, 2019

Record last verified: 2019-09

Locations

LE (1)