Chlorhexidine Gluconate Versus Povidone-Iodine as Vaginal Preparation Antiseptics Prior to Cesarean Delivery

A Single Site Prospective Randomized Controlled Trial Comparing Chlorhexidine Gluconate and Povidone-Iodine as Vaginal Preparation Antiseptics for Cesarean Section to Determine Effect on Bacterial Load

Primary Hypothesis: chlorhexidine gluconate antiseptic vaginal preparation is superior to povidone-iodine vaginal preparation in decreasing the bacterial load within the vagina when prepping prior to a cesarean section.

Study Overview

• Status: Completed
• Conditions: Infection, Bacterial
• Intervention / Treatment: Drug: Chlorhexidine Gluconate; Drug: Povidone-Iodine Scrub and Paint

Detailed Description

Patients who are planning cesarean will be recruited and consented for study participation at time of admission to labor and delivery.

Patients undergoing cesarean who meet inclusion/exclusion criteria will be randomized to one of two surgical preparations as follows: 1. Chlorhexidine gluconate (CHG); or, 2. Povidone-iodine scrub. Randomization will be performed by the consenting surgeon (listed as key personnel) after the patient has arrived into the operating room for cesarean. To establish baseline bacterial load, a qualitative BAL culture will be collected prior to the vaginal preparations. Pre-operative surgical site antisepsis will be performed according to randomization. All other surgical practices will remain at the surgeon's discretion according to standard of care at Metro Health Hospital.

At the completion of the cesarean, it is standard practice to perform a manual evacuation of blood clots from the lower uterine segment. The study culture will be obtained by the consenting surgeon immediately prior to manual evacuation. The cultures will then be sent to the lab for determination of total bacterial load of the vaginal area. The lab will be blinded toward which type of vaginal prep was used. Total colony count will be determined by certified lab personnel by adding all counts regardless of bacteria type. A secondary chart review will be performed by the investigator within 30 days of the postoperative period to evaluate for length of hospital stay, pain level, blood loss, any additional antibiotics received postoperatively, and the development of post-operative infection in subjects up to 30 days after discharge.

The research project will take place over a 12-month period of time at Metro Health Hospital. In review of Metro Health Labor and Delivery statistics for scheduled cesarean sections performed in 2016, an average of 18.8 were performed a month, giving a total of approximately 226 in a one-year period. Based on the research study published by Culligan, Kubik, Murphy, et al. comparing the two vaginal preparations for vaginal hysterectomy, an estimated sample size was calculated. Using the 90 minute colony counts of 20,472 (40,058) vs 1,221 (2,857), and using an alpha of .05 and power of 80% investigator found the sample size for each group should be at least 27. This sample size (27 X 2 groups) is very close to the sample size (50) in the Culligan experiment. In an attempt to ensure the most clinically significant, investigators anticipate screening between 70-100 patients with approximately 70-80% participation.

Analysis will be performed by the investigators for completeness, accuracy, strict adherence to study protocol, safety, and statistical significance. The investigators are also subject to periodic audits by the Institutional Review Board (IRB).

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Wyoming, Michigan, United States, 49519
      • Metro Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Scheduled low transverse cesarean section (can be primary or repeat)
• Term gestation ≥ 37 weeks

Exclusion Criteria:

• Allergy to either antiseptic
• Rupture of amniotic membranes
• Preterm gestation
• Active labor
• Emergency or unscheduled cesarean sections
• Infection diagnosis on admission
• Vaginal infection or any treatment of vulvovaginitis in prior 7 days
• Patients under the age of 18 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Chlorhexidine Gluconate; Pre-operative vagina preparation with Chlorhexidine Gluconate Intervention: Drug: Chlorhexidine Gluconate Other Name: Chlora-Prep	Drug: Chlorhexidine Gluconate; Pre-operative vaginal preparation with 4% Chlorhexidine Gluconate Intervention; Other Names: Chlora-Prep
EXPERIMENTAL: Povidone-Iodine Scrub and Paint; Pre-operative vagina preparation with Povidone-Iodine Scrub and Paint Intervention: Drug: Povidone-Iodine Scrub and Paint Other Name: Betadine	Drug: Povidone-Iodine Scrub and Paint; Pre-operative vaginal preparation with 10% Povidone-Iodine Scrub and Paint Intervention; Other Names: Betadine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial Load	Change in total bacterial load from baseline (pre-operative) vaginal culture	Immediately Post-operative prior to exit from operating room

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Hospital Stay	Number of days	2 or 3 post-operative days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Operative Infection	Presence of post-operative infection including endometritis, pelvic abscess, and skin/wound	up to 30 day post-operative

Collaborators and Investigators

• Sponsor: Metro Health, Michigan
• Investigators: Principal Investigator: Brad Irving, DO, FACOOG, Metro Health

Publications and helpful links

General Publications

• 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.
• Culligan PJ, Kubik K, Murphy M, Blackwell L, Snyder J. A randomized trial that compared povidone iodine and chlorhexidine as antiseptics for vaginal hysterectomy. Am J Obstet Gynecol. 2005 Feb;192(2):422-5. doi: 10.1016/j.ajog.2004.08.010.
• Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988.
• Levin I, Amer-Alshiek J, Avni A, Lessing JB, Satel A, Almog B. Chlorhexidine and alcohol versus povidone-iodine for antisepsis in gynecological surgery. J Womens Health (Larchmt). 2011 Mar;20(3):321-4. doi: 10.1089/jwh.2010.2391. Epub 2011 Feb 16.
• Tuuli MG, Liu J, Stout MJ, Martin S, Cahill AG, Odibo AO, Colditz GA, Macones GA. A Randomized Trial Comparing Skin Antiseptic Agents at Cesarean Delivery. N Engl J Med. 2016 Feb 18;374(7):647-55. doi: 10.1056/NEJMoa1511048. Epub 2016 Feb 4.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 2, 2017
• Primary Completion (ACTUAL): December 30, 2017
• Study Completion (ACTUAL): December 30, 2017

Study Registration Dates

• First Submitted: April 3, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (ACTUAL): April 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 11, 2019
• Last Update Submitted That Met QC Criteria: March 7, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Plasma Substitutes; Blood Substitutes; Chlorhexidine; Povidone-Iodine; Povidone; Chlorhexidine gluconate
• Other Study ID Numbers: VAGPrep

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No