Clinical trial NCT03640507: Vaginal Preparation With Chlorhexidine-alcohol vs. Povidine-iodine vs. Saline
Official title: The Effect of Vaginal Preparation With Chlorhexidine-alcohol vs. Povidine-iodine vs. Saline on Vaginal Bacteria Colony Counts in Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cesarean Section; Infection
Surgical Site Infection
Keywords: vaginal preparation
antisepsis
C-section
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Detailed description: This is a prospective trial of vaginal preparation (or vaginal cleansing/washing) on late preterm and term pregnancies admitted to Labor \& Delivery unit for cesarean delivery with three arms. Randomization allocation would be performed in 1:1:1 fashion for vaginal preparation with chlorhexidine-alcohol, povidine-iodine, and saline washes. A saline wash group is included to determine if the act of cleansing the vagina with a sponge alone reduces bacterial colony counts.

Eligibility criteria: Intervention Group (vaginal preparation)

Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Post-intervention Aerobic Bacterial Colony Counts
timeFrame: From intervention to 7 days post
measure: Post-intervention Anaerobic Bacterial Colony Counts
timeFrame: From intervention to 7 days post
Secondary outcomes:
measure: Baseline Aerobic Bacterial Colony Counts
timeFrame: From intervention to 7 days post
measure: Baseline Anaerobic Bacterial Colony Counts
timeFrame: From intervention to 7 days post
Other outcomes:
measure: Number of Participants Diagnosed With Postpartum Infections.
timeFrame: Up to six weeks postpartum
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital at Columbia University and Children's Hospital of New York
state: New York
Study officials:
affiliation: Columbia University Department of Microbiology and Immunology
name: Yiping Han, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.