Vaginal Scrubbing Clinical Trial
Official title:
Chlorhexidine Vaginal Cleansing Versus Iodine Prior to C-section and the Rate of Postoperative Infection: Randomized Clinical Trial
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.
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.
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