Trial Outcomes & Findings for Vaginal Preparation With Chlorhexidine-alcohol vs. Povidine-iodine vs. Saline (NCT NCT03640507)
NCT ID: NCT03640507
Last Updated: 2020-06-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
30 participants
Primary outcome timeframe
From intervention to 7 days post
Results posted on
2020-06-09
Participant Flow
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).
Participants need to be confirmed to be undergoing a Cesarean procedure.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
11
|
|
Overall Study
COMPLETED
|
10
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
Vaginal Preparation With Chlorhexidine-alcohol vs. Povidine-iodine vs. Saline
Baseline characteristics by cohort
| Measure |
Chlorhexidine-alcohol
n=10 Participants
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.
|
Povidine-iodine
n=9 Participants
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.
|
Saline
n=10 Participants
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.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
35.4 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
34.3 years
STANDARD_DEVIATION 4.9 • n=7 Participants
|
37.8 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
35.9 years
STANDARD_DEVIATION 5.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
BMI
|
33.0 kg/m^2
STANDARD_DEVIATION 7.5 • n=5 Participants
|
32.0 kg/m^2
STANDARD_DEVIATION 5.5 • n=7 Participants
|
35.6 kg/m^2
STANDARD_DEVIATION 9.4 • n=5 Participants
|
33.6 kg/m^2
STANDARD_DEVIATION 7.6 • n=4 Participants
|
|
Insurance Payer
Private
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Insurance Payer
Public
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Parity
|
1 prior deliveries
n=5 Participants
|
1 prior deliveries
n=7 Participants
|
1 prior deliveries
n=5 Participants
|
1 prior deliveries
n=4 Participants
|
|
GBS positivity
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Co-morbidity
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From intervention to 7 days postVaginal 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.
Outcome measures
| Measure |
Chlorhexidine-alcohol
n=10 Participants
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.
|
Povidine-iodine
n=9 Participants
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.
|
Saline
n=10 Participants
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.
|
|---|---|---|---|
|
Post-intervention Aerobic Bacterial Colony Counts
|
2.959 Log (CFU/mL)
Standard Error 0.624
|
0.945 Log (CFU/mL)
Standard Error 0.438
|
5.104 Log (CFU/mL)
Standard Error 0.299
|
PRIMARY outcome
Timeframe: From intervention to 7 days postVaginal 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.
Outcome measures
| Measure |
Chlorhexidine-alcohol
n=10 Participants
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.
|
Povidine-iodine
n=9 Participants
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.
|
Saline
n=10 Participants
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.
|
|---|---|---|---|
|
Post-intervention Anaerobic Bacterial Colony Counts
|
4.934 Log (CFU/mL)
Standard Error 0.514
|
2.637 Log (CFU/mL)
Standard Error 0.682
|
5.804 Log (CFU/mL)
Standard Error 0.212
|
SECONDARY outcome
Timeframe: From intervention to 7 days postVaginal 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.
Outcome measures
| Measure |
Chlorhexidine-alcohol
n=10 Participants
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.
|
Povidine-iodine
n=9 Participants
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.
|
Saline
n=10 Participants
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.
|
|---|---|---|---|
|
Baseline Aerobic Bacterial Colony Counts
|
5.942 Log (CFU/mL)
Standard Error 0.538
|
5.667 Log (CFU/mL)
Standard Error 0.437
|
6.480 Log (CFU/mL)
Standard Error 0.330
|
SECONDARY outcome
Timeframe: From intervention to 7 days postVaginal 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.
Outcome measures
| Measure |
Chlorhexidine-alcohol
n=10 Participants
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.
|
Povidine-iodine
n=9 Participants
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.
|
Saline
n=10 Participants
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.
|
|---|---|---|---|
|
Baseline Anaerobic Bacterial Colony Counts
|
7.096 Log (CFU/mL)
Standard Error 0.240
|
6.745 Log (CFU/mL)
Standard Error 0.339
|
7.145 Log (CFU/mL)
Standard Error 0.316
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to six weeks postpartumChart review to assess any maternal infections diagnosed during postpartum hospitalization or at the time of the postpartum visit.
Outcome measures
| Measure |
Chlorhexidine-alcohol
n=10 Participants
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.
|
Povidine-iodine
n=9 Participants
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.
|
Saline
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Participants Diagnosed With Postpartum Infections.
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Chlorhexidine-alcohol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Povidine-iodine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Cassandra R. Duffy, MD, MPH
Beth Israel Deaconess Medical Center
Phone: 617-667-2636
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place