Vaginal Preparation With Chlorhexidine-alcohol vs. Povidine-iodine vs. Saline

NCT03640507 | Completed Phase 2 Results FDA Drug

• 1 other identifier: AAAR4891
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see whether chlorhexidine is superior to povidine-iodine vaginal antisepsis at reducing bacteria colony counts in pregnant women by comparing three groups: vaginal washing with chlorhexidine-alcohol, vaginal washing with povidine-iodine, and vaginal washing with saline alone.

Conditions

Cesarean Section; Infection; Surgical Site Infection

Keywords

vaginal preparation; antisepsis; C-section

Outcome Measures

Primary Outcomes (2)

• Post-intervention Aerobic Bacterial Colony Counts

  Vaginal cultures are collected after the vaginal preparation intervention. These undergo serial dilutions and are incubated on Tryptic Soy Agar for seven days. Bacteria colony counts were determined by blinded investigators on day 7.

  From intervention to 7 days post

• Post-intervention Anaerobic Bacterial Colony Counts

  Vaginal cultures are collected after the vaginal preparation intervention. These undergo serial dilutions and are incubated on Tryptic Soy Agar for seven days. Bacteria colony counts were determined by blinded investigators on day 7.

  From intervention to 7 days post

Secondary Outcomes (2)

• Baseline Aerobic Bacterial Colony Counts

  From intervention to 7 days post

• Baseline Anaerobic Bacterial Colony Counts

  From intervention to 7 days post

Other Outcomes (1)

• Number of Participants Diagnosed With Postpartum Infections.

  Up to six weeks postpartum

Study Arms (3)

Chlorhexidine-alcohol

ACTIVE COMPARATOR

Subjects will receive vaginal preparation with chlorhexidine-alcohol.

Drug: Chlorhexidine-alcohol

Povidine-iodine

ACTIVE COMPARATOR

Subjects will receive vaginal preparation with povidine-iodine.

Drug: Povidine-iodine

Saline

PLACEBO COMPARATOR

Subjects will receive vaginal preparation with sterile saline.

Drug: Sterile saline

Interventions

Chlorhexidine-alcohol DRUG

Intervention is a 30-second vaginal preparation or topical wash with three chlorhexidine-alcohol 0.5% solution-soaked sponge sticks.

Also known as: Chlorohexidine Gluconate (CHG)

Chlorhexidine-alcohol

Povidine-iodine DRUG

Intervention is a 30-second vaginal preparation or topical wash with three povidine-iodine 10% solution-soaked sponge sticks.

Also known as: Betadine

Povidine-iodine

Sterile saline DRUG

Intervention is a 30-second vaginal preparation or topical wash with three sterile saline-soaked sponge sticks.

Also known as: Sodium chloride 0.9%

Saline

Eligibility Criteria

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

You may qualify if:

• Pregnant women admitted for cesarean delivery
• Gestational age greater than or equal to 34 weeks

You may not qualify if:

• Rupture of membranes or active labor
• Chorioamnionitis (prior to enrollment)
• Recent (within 4 weeks) antibiotic exposure
• Maternal HIV infection or immunocompromised state
• Known allergy to shellfish, iodine, or chlorhexidine

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

New York Presbyterian Hospital at Columbia University and Children's Hospital of New York

New York, New York, 10032, United States

Location

Related Publications (2)

• Duffy CR, Garcia-So J, Ajemian B, Gyamfi-Bannerman C, Han YW. A randomized trial of the bactericidal effects of chlorhexidine vs povidone-iodine vaginal preparation. Am J Obstet Gynecol MFM. 2020 Aug;2(3):100114. doi: 10.1016/j.ajogmf.2020.100114. Epub 2020 Apr 15.

  PMID: 33345865 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

Infections; Surgical Wound Infection

Interventions

Chlorhexidine; Ethanol; Povidone-Iodine; Sodium Chloride

Condition Hierarchy (Ancestors)

Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Alcohols; Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Limitations and Caveats

Small sample size.

Results Point of Contact

• Title: Cassandra R. Duffy, MD, MPH
• Organization: Beth Israel Deaconess Medical Center

cduffy3@bidmc.harvard.edu

617-667-2636

Study Officials

• Yiping Han, PhD

  Columbia University Department of Microbiology and Immunology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Microbial Sciences

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 21, 2018
• Study Start: October 1, 2018
• Primary Completion: May 8, 2019
• Study Completion: June 14, 2019
• Last Updated: June 9, 2020
• Results First Posted: June 9, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)