Chlorhexidine Gluconate Versus Povidone-Iodine as Vaginal Preparation Antiseptics Prior to Cesarean Delivery
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/13/2019 |
| Start Date: | May 2, 2017 |
| End Date: | December 30, 2017 |
A Single Site Prospective Randomized Controlled Trial Comparing Chlorhexidine Gluconate and Povidone-Iodine as Vaginal Preparation Antiseptics for Cesarean Section to Determine Effect on Bacterial Load
Primary Hypothesis: chlorhexidine gluconate antiseptic vaginal preparation is superior to
povidone-iodine vaginal preparation in decreasing the bacterial load within the vagina when
prepping prior to a cesarean section.
povidone-iodine vaginal preparation in decreasing the bacterial load within the vagina when
prepping prior to a cesarean section.
Patients who are planning cesarean will be recruited and consented for study participation at
time of admission to labor and delivery.
Patients undergoing cesarean who meet inclusion/exclusion criteria will be randomized to one
of two surgical preparations as follows: 1. Chlorhexidine gluconate (CHG); or, 2.
Povidone-iodine scrub. Randomization will be performed by the consenting surgeon (listed as
key personnel) after the patient has arrived into the operating room for cesarean. To
establish baseline bacterial load, a qualitative BAL culture will be collected prior to the
vaginal preparations. Pre-operative surgical site antisepsis will be performed according to
randomization. All other surgical practices will remain at the surgeon's discretion according
to standard of care at Metro Health Hospital.
At the completion of the cesarean, it is standard practice to perform a manual evacuation of
blood clots from the lower uterine segment. The study culture will be obtained by the
consenting surgeon immediately prior to manual evacuation. The cultures will then be sent to
the lab for determination of total bacterial load of the vaginal area. The lab will be
blinded toward which type of vaginal prep was used. Total colony count will be determined by
certified lab personnel by adding all counts regardless of bacteria type. A secondary chart
review will be performed by the investigator within 30 days of the postoperative period to
evaluate for length of hospital stay, pain level, blood loss, any additional antibiotics
received postoperatively, and the development of post-operative infection in subjects up to
30 days after discharge.
The research project will take place over a 12-month period of time at Metro Health Hospital.
In review of Metro Health Labor and Delivery statistics for scheduled cesarean sections
performed in 2016, an average of 18.8 were performed a month, giving a total of approximately
226 in a one-year period. Based on the research study published by Culligan, Kubik, Murphy,
et al. comparing the two vaginal preparations for vaginal hysterectomy, an estimated sample
size was calculated. Using the 90 minute colony counts of 20,472 (40,058) vs 1,221 (2,857),
and using an alpha of .05 and power of 80% investigator found the sample size for each group
should be at least 27. This sample size (27 X 2 groups) is very close to the sample size (50)
in the Culligan experiment. In an attempt to ensure the most clinically significant,
investigators anticipate screening between 70-100 patients with approximately 70-80%
participation.
Analysis will be performed by the investigators for completeness, accuracy, strict adherence
to study protocol, safety, and statistical significance. The investigators are also subject
to periodic audits by the Institutional Review Board (IRB).
time of admission to labor and delivery.
Patients undergoing cesarean who meet inclusion/exclusion criteria will be randomized to one
of two surgical preparations as follows: 1. Chlorhexidine gluconate (CHG); or, 2.
Povidone-iodine scrub. Randomization will be performed by the consenting surgeon (listed as
key personnel) after the patient has arrived into the operating room for cesarean. To
establish baseline bacterial load, a qualitative BAL culture will be collected prior to the
vaginal preparations. Pre-operative surgical site antisepsis will be performed according to
randomization. All other surgical practices will remain at the surgeon's discretion according
to standard of care at Metro Health Hospital.
At the completion of the cesarean, it is standard practice to perform a manual evacuation of
blood clots from the lower uterine segment. The study culture will be obtained by the
consenting surgeon immediately prior to manual evacuation. The cultures will then be sent to
the lab for determination of total bacterial load of the vaginal area. The lab will be
blinded toward which type of vaginal prep was used. Total colony count will be determined by
certified lab personnel by adding all counts regardless of bacteria type. A secondary chart
review will be performed by the investigator within 30 days of the postoperative period to
evaluate for length of hospital stay, pain level, blood loss, any additional antibiotics
received postoperatively, and the development of post-operative infection in subjects up to
30 days after discharge.
The research project will take place over a 12-month period of time at Metro Health Hospital.
In review of Metro Health Labor and Delivery statistics for scheduled cesarean sections
performed in 2016, an average of 18.8 were performed a month, giving a total of approximately
226 in a one-year period. Based on the research study published by Culligan, Kubik, Murphy,
et al. comparing the two vaginal preparations for vaginal hysterectomy, an estimated sample
size was calculated. Using the 90 minute colony counts of 20,472 (40,058) vs 1,221 (2,857),
and using an alpha of .05 and power of 80% investigator found the sample size for each group
should be at least 27. This sample size (27 X 2 groups) is very close to the sample size (50)
in the Culligan experiment. In an attempt to ensure the most clinically significant,
investigators anticipate screening between 70-100 patients with approximately 70-80%
participation.
Analysis will be performed by the investigators for completeness, accuracy, strict adherence
to study protocol, safety, and statistical significance. The investigators are also subject
to periodic audits by the Institutional Review Board (IRB).
Inclusion Criteria:
- Scheduled low transverse cesarean section (can be primary or repeat)
- Term gestation ≥ 37 weeks
Exclusion Criteria:
- Allergy to either antiseptic
- Rupture of amniotic membranes
- Preterm gestation
- Active labor
- Emergency or unscheduled cesarean sections
- Infection diagnosis on admission
- Vaginal infection or any treatment of vulvovaginitis in prior 7 days
- Patients under the age of 18 years
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