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

NCT02915289 | Completed Phase 3

• 1 other identifier: 2016-08-04 RUMC
• Study Type: interventional
• Target: 1,114
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Infection; Complication, Postoperative

Keywords

Caesarean section; Chlorhexidine gluconate

Outcome Measures

Primary Outcomes (1)

• Postoperative wound infection

  Erythema surrounding the incision site or pus-like incisional drainage in the presence or absence of fever

  0-14 days postpartum

Secondary Outcomes (3)

• Postpartum endometritis

  0-14 days post-partum

• Postoperative fever

  0-14 days post-partum

• Side effects

  0-14 days post-partum

Study Arms (2)

Povidone Iodine

ACTIVE COMPARATOR

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.

Procedure: Povidone Iodine

Chlorhexidine gluconate

ACTIVE COMPARATOR

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.

Procedure: Chlorhexidine gluconate

Interventions

Povidone Iodine PROCEDURE

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

Povidone Iodine

Chlorhexidine gluconate PROCEDURE

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

Chlorhexidine gluconate

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients at Richmond University Medical Center that have a non-emergent cesarean delivery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Richmond University Medical Center: lead

Study Sites (1)

Richmond University Medical Center

Staten Island, New York, 10310, United States

Location

Related Publications (2)

• 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.

  PMID: 33319753 DERIVED

• 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.

  PMID: 32335895 DERIVED

MeSH Terms

Conditions

Wound Infection; Postoperative Complications

Interventions

Povidone-Iodine; chlorhexidine gluconate

Condition Hierarchy (Ancestors)

Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Nisha Lakhi, MD

  Richmond University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: September 27, 2016
• Study Start: December 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: May 1, 2018
• Last Updated: September 14, 2018

Record last verified: 2018-09

Locations

US (1)