Wound Infection, Complication, Postoperative
Conditions
Keywords
Caesarean section, Chlorhexidine gluconate
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREPovidone Iodine
Vaginal preparation with 10% povidone iodine prior to non-emergent cesarean section.
PROCEDUREChlorhexidine gluconate
Vaginal preparation with 4% chlorhexidine gluconate prior to non-emergent cesarean section.
Sponsors
Richmond University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative wound infection | 0-14 days postpartum | Erythema surrounding the incision site or pus-like incisional drainage in the presence or absence of fever |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postpartum endometritis | 0-14 days post-partum | Clinical diagnosis with temperature of 100.4 degrees F or higher occurring 24 hours after surgery with uterine fundal tenderness or purulent lochia. |
| Postoperative fever | 0-14 days post-partum | Temperature greater than 38 degrees C or 100.4 degrees F |
| Side effects | 0-14 days post-partum | Patient reported side effects of vaginal preparation (allergy, irritation) |
Countries
United States
Outcome results
None listed