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

NCT03133312 | Completed Phase 4 FDA Drug

• 1 other identifier: VAGPrep
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infection, Bacterial

Outcome Measures

Primary Outcomes (1)

• Bacterial Load

  Change in total bacterial load from baseline (pre-operative) vaginal culture

  Immediately Post-operative prior to exit from operating room

Secondary Outcomes (1)

• Length of Hospital Stay

  2 or 3 post-operative days

Other Outcomes (1)

• Post-Operative Infection

  up to 30 day post-operative

Study Arms (2)

Chlorhexidine Gluconate

EXPERIMENTAL

Pre-operative vagina preparation with Chlorhexidine Gluconate Intervention: Drug: Chlorhexidine Gluconate Other Name: Chlora-Prep

Drug: Chlorhexidine Gluconate

Povidone-Iodine Scrub and Paint

EXPERIMENTAL

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

Interventions

Chlorhexidine Gluconate DRUG

Pre-operative vaginal preparation with 4% Chlorhexidine Gluconate Intervention

Also known as: Chlora-Prep

Chlorhexidine Gluconate

Povidone-Iodine Scrub and Paint DRUG

Pre-operative vaginal preparation with 10% Povidone-Iodine Scrub and Paint Intervention

Also known as: Betadine

Povidone-Iodine Scrub and Paint

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Metro Health, Michigan: lead

Study Sites (1)

Metro Health

Wyoming, Michigan, 49519, United States

Location

Related Publications (5)

• 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.

  PMID: 15695981 RESULT

• 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.

  PMID: 20054046 RESULT

• 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.

  PMID: 21323582 RESULT

• 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.

  PMID: 26844840 RESULT

• 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

Bacterial Infections

Interventions

chlorhexidine gluconate; Paint; Povidone-Iodine

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Manufactured Materials; Technology, Industry, and Agriculture; 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

Study Officials

• Brad Irving, DO, FACOOG

  Metro Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participant will not know which group they have been assigned to. The surgeon and OR staff performing the vaginal preparation will know, but the nursing staff in the recovery area will not. The lab will be blinded toward which type of surgical prep was used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Drug: Chlorhexidine Gluconate Applied to vagina pre-operatively for antiseptic; regulated as a drug by FDA Other Name: CHG Drug: Povidone-Iodine Scrub and Paint Applied to vagina pre-operatively for antiseptic; regulated as a drug by FDA Other Name: Betadine

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: April 28, 2017
• Study Start: May 2, 2017
• Primary Completion: December 30, 2017
• Study Completion: December 30, 2017
• Last Updated: March 11, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)