Cesarean Section; InfectionPhase 2/3NCT03640507
Vaginal Preparation With Chlorhexidine-alcohol vs. Povidine-iodine vs. Saline
A Phase 2/3 study testing Chlorhexidine-alcohol, Povidine-iodine and Sterile saline in people with Cesarean Section; Infection and Surgical Site Infection, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cesarean Section; Infection, Surgical Site Infection
- What is being tested?
- Chlorhexidine-alcohol, Povidine-iodine and Sterile saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 14 Jun 2019
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women admitted for cesarean delivery
- Gestational age greater than or equal to 34 weeks
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterian Hospital at Columbia University and Children's Hospital of New York
New York, New York, 10032
About this study
Official title: The Effect of Vaginal Preparation With Chlorhexidine-alcohol vs. Povidine-iodine vs. Saline on Vaginal Bacteria Colony Counts in Pregnant Women
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.
Read the 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.
- Being tested
- Chlorhexidine-alcohol, Povidine-iodine, Sterile saline
- Keywords
- vaginal preparation, antisepsis, C-section
- Medical subject headings
- Infections, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine-alcoholDrug
Also called Chlorohexidine Gluconate (CHG)
Intervention is a 30-second vaginal preparation or topical wash with three chlorhexidine-alcohol 0.5% solution-soaked sponge sticks.
Povidine-iodineDrug
Also called Betadine
Intervention is a 30-second vaginal preparation or topical wash with three povidine-iodine 10% solution-soaked sponge sticks.
Sterile salineDrug
Also called Sodium chloride 0.9%
Intervention is a 30-second vaginal preparation or topical wash with three sterile saline-soaked sponge sticks.
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine-alcohol | Active comparator | Subjects will receive vaginal preparation with chlorhexidine-alcohol. Receives: Drug: Chlorhexidine-alcohol |
| Povidine-iodine | Active comparator | Subjects will receive vaginal preparation with povidine-iodine. Receives: Drug: Povidine-iodine |
| Saline | Placebo comparator | Subjects will receive vaginal preparation with sterile saline. Receives: Drug: Sterile saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From intervention to 7 days post
Secondary outcomes (2)
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.
Measured: From intervention to 7 days post
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.
Measured: From intervention to 7 days post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start1 Oct 2018
- Primary completion8 May 2019
- Study completion14 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section; InfectionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yiping Weng Han, Columbia University
- Investigators
- Yiping Han, PhD, Principal investigator, Columbia University Department of Microbiology and Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640507
- Sponsor's protocol ID
- AAAR4891
- Status last verified
- May 2020
- First submitted
- 17 Aug 2018
- Last updated
- 9 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33345865Haas 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 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vaginal Preparation With Chlorhexidine-alcohol vs. Povidine-iodine vs. Saline on Vaginal Bacteria Colony Counts in Pregnant Women
- ClinicalTrials.gov ID
- NCT03640507
- Acronym / sponsor ID
- AAAR4891
- Keywords
- vaginal preparation, antisepsis, C-section
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 8 May 2019 (actual)
- Study completion
- 14 Jun 2019 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Posted 9 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine-alcohol | Active comparator | Drug: Chlorhexidine-alcoholSubjects will receive vaginal preparation with chlorhexidine-alcohol. |
| Povidine-iodine | Active comparator | Drug: Povidine-iodineSubjects will receive vaginal preparation with povidine-iodine. |
| Saline | Placebo comparator | Drug: Sterile salineSubjects will receive vaginal preparation with sterile saline. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant women admitted for cesarean delivery
- Gestational age greater than or equal to 34 weeks
Key exclusion criteria (5 listed)
- 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
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-alcoholAlso: Chlorohexidine Gluconate (CHG)Intervention is a 30-second vaginal preparation or topical wash with three chlorhexidine-alcohol 0.5% solution-soaked sponge sticks. | Drug | Chlorhexidine-alcohol |
| Povidine-iodineAlso: BetadineIntervention is a 30-second vaginal preparation or topical wash with three povidine-iodine 10% solution-soaked sponge sticks. | Drug | Povidine-iodine |
| Sterile salineAlso: Sodium chloride 0.9%Intervention is a 30-second vaginal preparation or topical wash with three sterile saline-soaked sponge sticks. | Drug | Saline |
Primary outcome
Post-intervention Aerobic Bacterial Colony Counts
Time frame: 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
Time frame: 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.
2 secondary outcomes
Baseline Aerobic Bacterial Colony Counts
Time frame: From intervention to 7 days post
Baseline Anaerobic Bacterial Colony Counts
Time frame: From intervention to 7 days post
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33345865Duffy 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.
- 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
Related trials for Cesarean Section; Infection
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
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Restoration of the Gut Microbiome After Cesarean Section
Microbial Colonization
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Timing of Cesarean Wound Dressing Removal on Wound Healing in Women With BMI ≥ 30 kg/m²
Cesarean Section, Surgical Wound Infection
Enrolling by invitation
A Randomized Controlled Trial Comparing the Incidence of Surgical Site Infections in Cesarean Section With and Without Subcutaneous Drain Placement at Queen Savang Vadhana Memorial Hospital
Surgical Site Infection (SSI)
Not yet recruiting
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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.
Yiping Han, PhD principal investigator
Columbia University Department of Microbiology and Immunology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Chlorhexidine-alcohol, Povidine-iodine and Sterile saline in people with Cesarean Section; Infection and Surgical Site Infection, run by Columbia University 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 5 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 9 Jun 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Post-intervention Aerobic Bacterial Colony Counts (time frame: From intervention to 7 days post). The study lists 2 primary outcomes in all. 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 NCT03640507, which also lists 2 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 9 Jun 2020.