Chlorhexidine Gluconate vs Povidone-Iodine Vaginal Cleansing Solution Prior to Cesarean Delivery

NCT ID: NCT02915289

Last Updated: 2018-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-05-31

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.

Conditions

Wound Infection; Complication, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Povidone Iodine

10% povidone iodine solution will be used for vaginal cleansing prior to non-emergent cesarean section. The preparation will be applied according to the manufacture guidelines with a minimum of four completed minutes of drying time before placement of surgical drapes. The group will receive standard obstetrical care, continuous fetal monitoring, and pre-operative prophylactic antibiotics at least one hour prior to skin incision.

Group Type: ACTIVE_COMPARATOR

Povidone Iodine

Intervention Type: PROCEDURE

Vaginal preparation with 10% povidone iodine prior to non-emergent cesarean section.

Chlorhexidine gluconate

4% chlorhexidine gluconate solution will be used for vaginal cleansing prior to non-emergent cesarean section. The preparation will be applied according to manufacture guidelines. The group will receive standard obstetrical care, continuous fetal monitoring, and pre-operative prophylactic antibiotics at least one hour prior to skin incision.

Group Type: ACTIVE_COMPARATOR

Chlorhexidine gluconate

Intervention Type: PROCEDURE

Vaginal preparation with 4% chlorhexidine gluconate prior to non-emergent cesarean section.

Interventions

Povidone Iodine

Vaginal preparation with 10% povidone iodine prior to non-emergent cesarean section.

Intervention Type: PROCEDURE

Chlorhexidine gluconate

Vaginal preparation with 4% chlorhexidine gluconate prior to non-emergent cesarean section.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Richmond University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Nisha Lakhi, MD

Director of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nisha Lakhi, MD

Role: PRINCIPAL_INVESTIGATOR

Richmond University Medical Center

Locations

Richmond University Medical Center

Staten Island, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33319753 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32335895 (View on PubMed)

Other Identifiers

2016-08-04 RUMC

Identifier Type: -

Identifier Source: org_study_id