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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine-alcohol | Active Comparator | Subjects will receive vaginal preparation with chlorhexidine-alcohol. |
|
| Povidine-iodine | Active Comparator | Subjects will receive vaginal preparation with povidine-iodine. |
|
| Saline | Placebo Comparator | Subjects will receive vaginal preparation with sterile saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine-alcohol | Drug | Intervention is a 30-second vaginal preparation or topical wash with three chlorhexidine-alcohol 0.5% solution-soaked sponge sticks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Aerobic Bacterial Colony Counts | Vaginal cultures are collected immediately prior to 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Diagnosed With Postpartum Infections. | Chart review to assess any maternal infections diagnosed during postpartum hospitalization or at the time of the postpartum visit. | Up to six weeks postpartum |
Intervention Group (vaginal preparation)
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yiping Han, PhD | Columbia University Department of Microbiology and Immunology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Presbyterian Hospital at Columbia University and Children's Hospital of New York | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33345865 | Derived | 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. | |
| 32335895 | 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. |
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Participants need to be confirmed to be undergoing a Cesarean procedure.
Participants will be recruited in-person only by study investigators/trained research personnel after admission to labor and delivery prior to administration of sedatives, anesthetics, or other mental-altering medications (note: some patients included in study will be in labor and may have already received regional anesthesia).
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| ID | Title | Description |
|---|---|---|
| FG000 | Chlorhexidine-alcohol | Subjects will receive vaginal preparation with chlorhexidine-alcohol. Chlorhexidine-alcohol: Intervention is a 30-second vaginal preparation or topical wash with three chlorhexidine-alcohol 0.5% solution-soaked sponge sticks. |
| FG001 | Povidine-iodine | Subjects will receive vaginal preparation with povidine-iodine. Povidine-iodine: Intervention is a 30-second vaginal preparation or topical wash with three povidine-iodine 10% solution-soaked sponge sticks. |
| FG002 | Saline | Subjects will receive vaginal preparation with sterile saline. Sterile saline: Intervention is a 30-second vaginal preparation or topical wash with three sterile saline-soaked sponge sticks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chlorhexidine-alcohol | Subjects will receive vaginal preparation with chlorhexidine-alcohol. Chlorhexidine-alcohol: Intervention is a 30-second vaginal preparation or topical wash with three chlorhexidine-alcohol 0.5% solution-soaked sponge sticks. |
| BG001 | Povidine-iodine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | Log (CFU/mL) | From intervention to 7 days post |
|
From baseline to 6 weeks postpartum
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chlorhexidine-alcohol | Subjects will receive vaginal preparation with chlorhexidine-alcohol. Chlorhexidine-alcohol: Intervention is a 30-second vaginal preparation or topical wash with three chlorhexidine-alcohol 0.5% solution-soaked sponge sticks. |
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Small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cassandra R. Duffy, MD, MPH | Beth Israel Deaconess Medical Center | 617-667-2636 | cduffy3@bidmc.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 10, 2019 | May 12, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002710 | Chlorhexidine |
| D000431 | Ethanol |
| D011206 | Povidone-Iodine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D000438 |
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|
| Povidine-iodine | Drug | Intervention is a 30-second vaginal preparation or topical wash with three povidine-iodine 10% solution-soaked sponge sticks. |
|
|
| Sterile saline | Drug | Intervention is a 30-second vaginal preparation or topical wash with three sterile saline-soaked sponge sticks. |
|
|
| Baseline Anaerobic Bacterial Colony Counts |
Vaginal cultures are collected immediately prior to 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 |
Subjects will receive vaginal preparation with povidine-iodine. Povidine-iodine: Intervention is a 30-second vaginal preparation or topical wash with three povidine-iodine 10% solution-soaked sponge sticks. |
| BG002 | Saline | Subjects will receive vaginal preparation with sterile saline. Sterile saline: Intervention is a 30-second vaginal preparation or topical wash with three sterile saline-soaked sponge sticks. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Insurance Payer | Count of Participants | Participants |
|
| Parity | Median | Inter-Quartile Range | prior deliveries |
|
| GBS positivity | As assessed by routine late third trimester screening (i.e. rectovaginal culture). | Count of Participants | Participants |
|
| Co-morbidity | Includes maternal cardiac disease, diabetes on medications, hypertensive disease and cholestasis of pregnancy | Count of Participants | Participants |
|
| OG002 | Saline | Subjects will receive vaginal preparation with sterile saline. Sterile saline: Intervention is a 30-second vaginal preparation or topical wash with three sterile saline-soaked sponge sticks. |
|
|
| Primary | 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. | Posted | Mean | Standard Error | Log (CFU/mL) | From intervention to 7 days post |
|
|
|
| Secondary | Baseline Aerobic Bacterial Colony Counts | Vaginal cultures are collected immediately prior to 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. | Posted | Mean | Standard Error | Log (CFU/mL) | From intervention to 7 days post |
|
|
|
| Secondary | Baseline Anaerobic Bacterial Colony Counts | Vaginal cultures are collected immediately prior to 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. | Posted | Mean | Standard Error | Log (CFU/mL) | From intervention to 7 days post |
|
|
|
| Other Pre-specified | Number of Participants Diagnosed With Postpartum Infections. | Chart review to assess any maternal infections diagnosed during postpartum hospitalization or at the time of the postpartum visit. | Posted | Count of Participants | Participants | Up to six weeks postpartum |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Povidine-iodine | Subjects will receive vaginal preparation with povidine-iodine. Povidine-iodine: Intervention is a 30-second vaginal preparation or topical wash with three povidine-iodine 10% solution-soaked sponge sticks. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG002 | Saline | Subjects will receive vaginal preparation with sterile saline. Sterile saline: Intervention is a 30-second vaginal preparation or topical wash with three sterile saline-soaked sponge sticks. | 0 | 11 | 0 | 11 | 0 | 11 |
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| Alcohols |
| D007466 | Iodophors |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D011145 | Polyvinyls |
| D014753 | Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D011205 | Povidone |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D017670 | Sodium Compounds |