Cesarean Section; Infection, Surgical Site Infection
Conditions
Keywords
vaginal preparation, antisepsis, C-section
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.
Interventions
Intervention is a 30-second vaginal preparation or topical wash with three chlorhexidine-alcohol 0.5% solution-soaked sponge sticks.
DRUGPovidine-iodine
Intervention is a 30-second vaginal preparation or topical wash with three povidine-iodine 10% solution-soaked sponge sticks.
DRUGSterile saline
Intervention is a 30-second vaginal preparation or topical wash with three sterile saline-soaked sponge sticks.
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-intervention Aerobic Bacterial Colony Counts | From intervention to 7 days post | 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. |
| Post-intervention Anaerobic Bacterial Colony Counts | From intervention to 7 days post | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Aerobic Bacterial Colony Counts | From intervention to 7 days post | 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. |
| Baseline Anaerobic Bacterial Colony Counts | From intervention to 7 days post | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Diagnosed With Postpartum Infections. | Up to six weeks postpartum | Chart review to assess any maternal infections diagnosed during postpartum hospitalization or at the time of the postpartum visit. |
Countries
United States
Participant flow
Recruitment details
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).
Pre-assignment details
Participants need to be confirmed to be undergoing a Cesarean procedure.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 9 |
| 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. | 10 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Povidine-iodine | Saline | Total | Chlorhexidine-alcohol |
|---|---|---|---|---|
| Age, Continuous | 34.3 years STANDARD_DEVIATION 4.9 | 37.8 years STANDARD_DEVIATION 4.6 | 35.9 years STANDARD_DEVIATION 5.2 | 35.4 years STANDARD_DEVIATION 5.8 |
| BMI | 32.0 kg/m^2 STANDARD_DEVIATION 5.5 | 35.6 kg/m^2 STANDARD_DEVIATION 9.4 | 33.6 kg/m^2 STANDARD_DEVIATION 7.6 | 33.0 kg/m^2 STANDARD_DEVIATION 7.5 |
| Co-morbidity | 3 Participants | 5 Participants | 10 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 3 Participants | 11 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 7 Participants | 18 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| GBS positivity | 2 Participants | 4 Participants | 9 Participants | 3 Participants |
| Insurance Payer Private | 8 Participants | 8 Participants | 23 Participants | 7 Participants |
| Insurance Payer Public | 1 Participants | 2 Participants | 6 Participants | 3 Participants |
| Parity | 1 prior deliveries | 1 prior deliveries | 1 prior deliveries | 1 prior deliveries |
| Race/Ethnicity, Customized Black | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 1 Participants | 5 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 6 Participants | 8 Participants | 23 Participants | 9 Participants |
| Sex: Female, Male Female | 9 Participants | 10 Participants | 29 Participants | 10 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 9 | 0 / 11 |
| other Total, other adverse events | 0 / 10 | 0 / 9 | 0 / 11 |
| serious Total, serious adverse events | 0 / 10 | 0 / 9 | 0 / 11 |
Outcome results
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.
Time frame: From intervention to 7 days post
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chlorhexidine-alcohol | Post-intervention Aerobic Bacterial Colony Counts | 2.959 Log (CFU/mL) | Standard Error 0.624 |
| Povidine-iodine | Post-intervention Aerobic Bacterial Colony Counts | 0.945 Log (CFU/mL) | Standard Error 0.438 |
| Saline | Post-intervention Aerobic Bacterial Colony Counts | 5.104 Log (CFU/mL) | Standard Error 0.299 |
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.
Time frame: From intervention to 7 days post
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chlorhexidine-alcohol | Post-intervention Anaerobic Bacterial Colony Counts | 4.934 Log (CFU/mL) | Standard Error 0.514 |
| Povidine-iodine | Post-intervention Anaerobic Bacterial Colony Counts | 2.637 Log (CFU/mL) | Standard Error 0.682 |
| Saline | Post-intervention Anaerobic Bacterial Colony Counts | 5.804 Log (CFU/mL) | Standard Error 0.212 |
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.
Time frame: From intervention to 7 days post
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chlorhexidine-alcohol | Baseline Aerobic Bacterial Colony Counts | 5.942 Log (CFU/mL) | Standard Error 0.538 |
| Povidine-iodine | Baseline Aerobic Bacterial Colony Counts | 5.667 Log (CFU/mL) | Standard Error 0.437 |
| Saline | Baseline Aerobic Bacterial Colony Counts | 6.480 Log (CFU/mL) | Standard Error 0.33 |
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.
Time frame: From intervention to 7 days post
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chlorhexidine-alcohol | Baseline Anaerobic Bacterial Colony Counts | 7.096 Log (CFU/mL) | Standard Error 0.24 |
| Povidine-iodine | Baseline Anaerobic Bacterial Colony Counts | 6.745 Log (CFU/mL) | Standard Error 0.339 |
| Saline | Baseline Anaerobic Bacterial Colony Counts | 7.145 Log (CFU/mL) | Standard Error 0.316 |
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.
Time frame: Up to six weeks postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chlorhexidine-alcohol | Number of Participants Diagnosed With Postpartum Infections. | 0 Participants |
| Povidine-iodine | Number of Participants Diagnosed With Postpartum Infections. | 0 Participants |
| Saline | Number of Participants Diagnosed With Postpartum Infections. | 0 Participants |