Chlorhexidine Gluconate vs Povidone-Iodine Vaginal Cleansing Solution Prior to Cesarean Delivery
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Women's Studies |
| Therapuetic Areas: | Other, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/16/2018 |
| Start Date: | December 2016 |
| End Date: | May 2018 |
Chlorhexidine Gluconate vs Povidone-Iodine Vaginal Cleansing Solution Prior to Cesarean Delivery: A Randomized Comparator Controlled Trial
Endometritis, an infection of the uterus in the postpartum period, has been shown to
complicate the postoperative course of a cesarean delivery in 6% to 27% of cases. Vaginal
cleansing prior to cesarean delivery has been shown to minimize the presence of
micro-organisms and risk of infection. Although povidone-iodine is the most commonly used
anti-septic for surgical preparation of the vagina, it is not an ideal agent due to it's
diminished efficacy in acidic vaginal pH and in the presence of blood. Chlorhexidine
gluconate, on the other hand, has demonstrated superior disinfectant properties in several
clinical trials, as compared to povidone iodine. In this randomized, comparator controlled,
study the investigators will be comparing chlorhexidine gluconate vs povidone iodine for
intrapartum vaginal preparation in women undergoing non-emergent cesarean delivery.
complicate the postoperative course of a cesarean delivery in 6% to 27% of cases. Vaginal
cleansing prior to cesarean delivery has been shown to minimize the presence of
micro-organisms and risk of infection. Although povidone-iodine is the most commonly used
anti-septic for surgical preparation of the vagina, it is not an ideal agent due to it's
diminished efficacy in acidic vaginal pH and in the presence of blood. Chlorhexidine
gluconate, on the other hand, has demonstrated superior disinfectant properties in several
clinical trials, as compared to povidone iodine. In this randomized, comparator controlled,
study the investigators will be comparing chlorhexidine gluconate vs povidone iodine for
intrapartum vaginal preparation in women undergoing non-emergent cesarean delivery.
This is a randomized, comparator controlled, study of intrapartum vaginal preparation with
either chlorhexidine gluconate or povidone-iodine solution. Women undergoing non-emergent
cesarean delivery will be randomized to receive vaginal cleansing with either 4%
chlorhexidine solution or 10% providone-iodine solution.
The study will have two arms that will be randomized in a 1:1 ratio. After inclusion criteria
have been satisfied, subjects in the comparator control arm will receive vaginal preparation
with 10% provodone-iodine solution prior the skin incision. Subjects in the study arm will
receive vaginal preparation with chlorohexidine gluconate 4% solution. The selected skin
preparation will be applied according to the manufacture guidelines with a minimum of four
completed minutes of drying time before placement of surgical drapes. A block randomization
method will be used to control for variations in care. Both groups will receive standard
obstetrical care, continuous fetal monitoring, and pre-operative prophylactic antibiotics at
least one hour prior to skin incision.
either chlorhexidine gluconate or povidone-iodine solution. Women undergoing non-emergent
cesarean delivery will be randomized to receive vaginal cleansing with either 4%
chlorhexidine solution or 10% providone-iodine solution.
The study will have two arms that will be randomized in a 1:1 ratio. After inclusion criteria
have been satisfied, subjects in the comparator control arm will receive vaginal preparation
with 10% provodone-iodine solution prior the skin incision. Subjects in the study arm will
receive vaginal preparation with chlorohexidine gluconate 4% solution. The selected skin
preparation will be applied according to the manufacture guidelines with a minimum of four
completed minutes of drying time before placement of surgical drapes. A block randomization
method will be used to control for variations in care. Both groups will receive standard
obstetrical care, continuous fetal monitoring, and pre-operative prophylactic antibiotics at
least one hour prior to skin incision.
Inclusion Criteria:
- Patients at Richmond University Medical Center that have a non-emergent cesarean
delivery
Exclusion Criteria:
- Emergent cesarean delivery, less than 18 years of age, chorioamnionitis before
randomization, intrapartum fever prior to randomization, or known or suspected allergy
to chlorhexidine or iodine.
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