Clinical trial NCT02915289: Chlorhexidine Gluconate vs Povidone-Iodine Vaginal Cleansing Solution Prior to Cesarean Delivery
Official title: Chlorhexidine Gluconate vs Povidone-Iodine Vaginal Cleansing Solution Prior to Cesarean Delivery: A Randomized Comparator Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Wound Infection
Complication, Postoperative
Keywords: Caesarean section
Chlorhexidine gluconate
Lead sponsor: Richmond University Medical Center
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 1114
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative wound infection
timeFrame: 0-14 days postpartum
Secondary outcomes:
measure: Postpartum endometritis
timeFrame: 0-14 days post-partum
measure: Postoperative fever
timeFrame: 0-14 days post-partum
measure: Side effects
timeFrame: 0-14 days post-partum
Other outcomes:
Locations:
city: Staten Island
country: United States
facility: Richmond University Medical Center
state: New York
Study officials:
affiliation: Richmond University Medical Center
name: Nisha Lakhi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haas DM, Morgan S, Contreras K, Kimball S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2020 Apr 26;4(4):CD007892. doi: 10.1002/14651858.CD007892.pub7.
citation: Lakhi NA, Tricorico G, Osipova Y, Moretti ML. Vaginal cleansing with chlorhexidine gluconate or povidone-iodine prior to cesarean delivery: a randomized comparator-controlled trial. Am J Obstet Gynecol MFM. 2019 Mar;1(1):2-9. doi: 10.1016/j.ajogmf.2019.03.004. Epub 2019 Mar 19.