Infection, BacterialPhase 4NCT03133312
Chlorhexidine Gluconate Versus Povidone-Iodine as Vaginal Preparation Antiseptics Prior to Cesarean Delivery
A Phase 4 study testing Chlorhexidine Gluconate and Povidone-Iodine Scrub and Paint in people with Infection, Bacterial, run by Metro Health, Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infection, Bacterial
- What is being tested?
- Chlorhexidine Gluconate and Povidone-Iodine Scrub and Paint
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2017to 30 Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled low transverse cesarean section (can be primary or repeat)
- Term gestation ≥ 37 weeks
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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).
- Conditions
- Infection, Bacterial
- Being tested
- Chlorhexidine Gluconate, Povidone-Iodine Scrub and Paint
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine GluconateDrug
Also called Chlora-Prep
Pre-operative vaginal preparation with 4% Chlorhexidine Gluconate Intervention
Povidone-Iodine Scrub and PaintDrug
Also called Betadine
Pre-operative vaginal preparation with 10% Povidone-Iodine Scrub and Paint Intervention
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine Gluconate | Experimental | Pre-operative vagina preparation with Chlorhexidine Gluconate Intervention: Drug: Chlorhexidine Gluconate Other Name: Chlora-Prep Receives: Drug: Chlorhexidine Gluconate |
| Povidone-Iodine Scrub and Paint | Experimental | Pre-operative vagina preparation with Povidone-Iodine Scrub and Paint Intervention: Drug: Povidone-Iodine Scrub and Paint Other Name: Betadine Receives: Drug: Povidone-Iodine Scrub and Paint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial Load
Change in total bacterial load from baseline (pre-operative) vaginal culture
Measured: Immediately Post-operative prior to exit from operating room
Secondary outcomes (1)
Length of Hospital Stay
Number of days
Measured: 2 or 3 post-operative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start2 May 2017
- Primary completion30 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Infection, BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Drug: Chlorhexidine Gluconate Applied to vagina pre-operatively for antiseptic; regulated as a drug by FDA Other Name: CHG Drug: Povidone-Iodine Scrub and Paint Applied to vagina pre-operatively for antiseptic; regulated as a drug by FDA Other Name: Betadine
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metro Health, Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brad Irving, DO, FACOOG, Metro Health, Michigan
- Investigators
- Brad Irving, DO, FACOOG, Principal investigator, Metro Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133312
- Sponsor's protocol ID
- VAGPrep
- Status last verified
- Mar 2019
- First submitted
- 3 Apr 2017
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Culligan PJ, Kubik K, Murphy M, Blackwell L, Snyder J. A randomized trial that compared povidone iodine and chlorhexidine as antiseptics for vaginal hysterectomy. Am J Obstet Gynecol. 2005 Feb;192(2):422-5. doi: 10.1016/j.ajog.2004.08.010.
PubMed 15695981Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988.
PubMed 20054046Levin I, Amer-Alshiek J, Avni A, Lessing JB, Satel A, Almog B. Chlorhexidine and alcohol versus povidone-iodine for antisepsis in gynecological surgery. J Womens Health (Larchmt). 2011 Mar;20(3):321-4. doi: 10.1089/jwh.2010.2391. Epub 2011 Feb 16.
PubMed 21323582Tuuli MG, Liu J, Stout MJ, Martin S, Cahill AG, Odibo AO, Colditz GA, Macones GA. A Randomized Trial Comparing Skin Antiseptic Agents at Cesarean Delivery. N Engl J Med. 2016 Feb 18;374(7):647-55. doi: 10.1056/NEJMoa1511048. Epub 2016 Feb 4.
PubMed 26844840Haas 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.
PubMed 32335895
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03133312
- Acronym / sponsor ID
- VAGPrep
- Conditions
- Infection, Bacterial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Metro Health, MichiganUniversity, hospital or other
- Study start
- 2 May 2017 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Drug: Chlorhexidine Gluconate Applied to vagina pre-operatively for antiseptic; regulated as a drug by FDA Other Name: CHG Drug: Povidone-Iodine Scrub and Paint Applied to vagina pre-operatively for antiseptic; regulated as a drug by FDA Other Name: Betadine
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine Gluconate | Experimental | Drug: Chlorhexidine GluconatePre-operative vagina preparation with Chlorhexidine Gluconate Intervention: Drug: Chlorhexidine Gluconate Other Name: Chlora-Prep |
| Povidone-Iodine Scrub and Paint | Experimental | Drug: Povidone-Iodine Scrub and PaintPre-operative vagina preparation with Povidone-Iodine Scrub and Paint Intervention: Drug: Povidone-Iodine Scrub and Paint Other Name: Betadine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled low transverse cesarean section (can be primary or repeat)
- Term gestation ≥ 37 weeks
Key exclusion criteria (8 listed)
- Allergy to either antiseptic
- Rupture of amniotic membranes
- Preterm gestation
- Active labor
- Emergency or unscheduled cesarean sections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine GluconateAlso: Chlora-PrepPre-operative vaginal preparation with 4% Chlorhexidine Gluconate Intervention | Drug | Chlorhexidine Gluconate |
| Povidone-Iodine Scrub and PaintAlso: BetadinePre-operative vaginal preparation with 10% Povidone-Iodine Scrub and Paint Intervention | Drug | Povidone-Iodine Scrub and Paint |
Primary outcome
Bacterial Load
Time frame: Immediately Post-operative prior to exit from operating room
Change in total bacterial load from baseline (pre-operative) vaginal culture
1 secondary outcome
Length of Hospital Stay
Time frame: 2 or 3 post-operative days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Results publication: PubMed 15695981Culligan PJ, Kubik K, Murphy M, Blackwell L, Snyder J. A randomized trial that compared povidone iodine and chlorhexidine as antiseptics for vaginal hysterectomy. Am J Obstet Gynecol. 2005 Feb;192(2):422-5. doi: 10.1016/j.ajog.2004.08.010.
- Results publication: PubMed 20054046Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988.
- Results publication: PubMed 21323582Levin I, Amer-Alshiek J, Avni A, Lessing JB, Satel A, Almog B. Chlorhexidine and alcohol versus povidone-iodine for antisepsis in gynecological surgery. J Womens Health (Larchmt). 2011 Mar;20(3):321-4. doi: 10.1089/jwh.2010.2391. Epub 2011 Feb 16.
- Results publication: PubMed 26844840Tuuli MG, Liu J, Stout MJ, Martin S, Cahill AG, Odibo AO, Colditz GA, Macones GA. A Randomized Trial Comparing Skin Antiseptic Agents at Cesarean Delivery. N Engl J Med. 2016 Feb 18;374(7):647-55. doi: 10.1056/NEJMoa1511048. Epub 2016 Feb 4.
- Derived from this study: PubMed 32335895Haas 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brad Irving, DO, FACOOG principal investigator
Metro Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chlorhexidine Gluconate and Povidone-Iodine Scrub and Paint in people with Infection, Bacterial, run by Metro Health, Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial Load (time frame: Immediately Post-operative prior to exit from operating room). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03133312, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019.