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

M

Makassed General Hospital

Status

Completed

Conditions

Vaginal Scrubbing

Treatments

Other: Iodine
Other: Antibiotics
Other: Chlorhexidine

Study type

Interventional

Funder types

Other

Identifiers

NCT03431701
01022018

Details and patient eligibility

About

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.

Full 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.

Enrollment

333 patients

Sex

Female

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

333 participants in 2 patient groups

Group chlorhexidine
Experimental group
Description:
Patients will receive chlorhexidine abdominal and vaginal scrubbing
Treatment:
Other: Antibiotics
Other: Chlorhexidine
Group iodine
Active Comparator group
Description:
Patients will receive iodine abdominal and vaginal scrubbing
Treatment:
Other: Antibiotics
Other: Iodine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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