Complications; Cesarean SectionNCT02495753
Vaginal Cleansing Before Cesarean Delivery to Reduce Infection
A study testing Vaginal Cleansing and Abdominal Cleansing in people with Complications; Cesarean Section, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to test the hypothesis that vaginal cleansing with povidone-iodine solution immediately prior to cesarean delivery reduces postcesarean infectious morbidity. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Complications; Cesarean Section
- What is being tested?
- Vaginal Cleansing and Abdominal Cleansing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 608 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Apr 2021
- Phase
- Interventional
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women undergoing cesarean delivery after labor at Barnes-Jewish Hospital.
Who cannot join
- Inability to obtain consent
- known or suspected allergy to iodine or shellfish
- women with active herpes simplex virus infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vaginal Cleansing Before Cesarean Delivery to Reduce Infection: A Randomized Trial
The purpose of this study is to test the hypothesis that vaginal cleansing with povidone-iodine solution immediately prior to cesarean delivery reduces postcesarean infectious morbidity.
Read the detailed description
Cesarean delivery is the most common surgical procedure performed on women in the US; nearly 1.3 million are performed each year. Postoperative infectious morbidity is the most common complication of cesarean delivery. Post-cesarean infectious morbidity is often the result of indigenous vaginal flora that ascend into the uterus at the time of surgery. Thus, reducing vaginal microbial load may reduce post-cesarean infection. However, results from studies assessing the role of vaginal cleansing prior to cesarean have been mixed.
The investigators will perform a randomized controlled clinical trial to test the hypothesis that vaginal cleansing with povidone-iodine solution immediately prior to cesarean delivery reduces postcesarean infectious morbidity.
- Conditions
- Complications; Cesarean Section
- Being tested
- Vaginal Cleansing, Abdominal Cleansing
- Keywords
- cesarean section, wound infection, vaginal cleansing, endometritis
- Medical subject headings
- Wound Infection, Endometritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal CleansingProcedure or surgery
The vagina will be prepped in two passes with sponge sticks soaked in 1% povidone-iodine solution from a prepackaged sterile pouch.
Abdominal CleansingProcedure or surgery
The abdomen will be cleansed using chlorhexidine or betadine according to surgeon's preference prior to cesarean.
| Study group | Role | What they receive |
|---|---|---|
| Abdominal and Vaginal Cleansing | Experimental | In the treatment arm, the vagina will be cleansed prior to usual abdominal cleansing before cesarean section. Receives: Procedure: Vaginal Cleansing; Procedure: Abdominal Cleansing |
| Abdominal Cleansing Alone | Active comparator | In the control arm, abdominal cleansing will be performed per routine with no vaginal cleansing. Receives: Procedure: Abdominal Cleansing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Postoperative Infectious Morbidity
Maternal fever, endometritis, intrabdominal infection or abscess, wound complication within 30 days of delivery or wound infection.
Measured: 30 days postoperatively
Secondary outcomes (5)
Adverse Reaction to Vaginal Cleansing
Hypersensitivity Reaction or more severe allergic reaction
Measured: 30 days postoperatively
Length of Hospital Stay
Days in hospital
Measured: 30 days postoperatively
Number of readmissions to hospital for infectious morbidity.
Number of times patient is readdmitted for any infectious morbidity.
Measured: 30 days postoperatively
Treatment for neonatal Sepsis
Any antibioitics given for neonate with suspected sepsis.
Measured: 30 days postoperatively
Number of outpatient visits for infectious morbidiy.
Number of outpatient or emergency room visits related to infectious morbidity.
Measured: 30 days postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionJan 2021
- Study completionApr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Complications; Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 608 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495753
- Sponsor's protocol ID
- 201505127
- Status last verified
- Aug 2021
- First submitted
- 28 Jun 2015
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Temming LA, Frolova AI, Raghuraman N, Tuuli MG, Cahill AG. Vaginal cleansing before unscheduled cesarean delivery to reduce infection: a randomized clinical trial. Am J Obstet Gynecol. 2023 Jun;228(6):739.e1-739.e14. doi: 10.1016/j.ajog.2022.11.1300. Epub 2022 Nov 30.
PubMed 36462539Haas 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 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Cleansing Before Cesarean Delivery to Reduce Infection: A Randomized Trial
- ClinicalTrials.gov ID
- NCT02495753
- Acronym / sponsor ID
- 201505127
- Conditions
- Complications; Cesarean Section
- Keywords
- cesarean section, wound infection, vaginal cleansing, endometritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 608 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jan 2021 (actual)
- Study completion
- Apr 2021 (actual)
- First posted
- 13 Jul 2015 (estimated)
- 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.
The purpose of this study is to test the hypothesis that vaginal cleansing with povidone-iodine solution immediately prior to cesarean delivery reduces postcesarean infectious morbidity.
Detailed description
Cesarean delivery is the most common surgical procedure performed on women in the US; nearly 1.3 million are performed each year. Postoperative infectious morbidity is the most common complication of cesarean delivery. Post-cesarean infectious morbidity is often the result of indigenous vaginal flora that ascend into the uterus at the time of surgery. Thus, reducing vaginal microbial load may reduce post-cesarean infection. However, results from studies assessing the role of vaginal cleansing prior to cesarean have been mixed.
The investigators will perform a randomized controlled clinical trial to test the hypothesis that vaginal cleansing with povidone-iodine solution immediately prior to cesarean delivery reduces postcesarean infectious morbidity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominal and Vaginal Cleansing | Experimental | Procedure: Vaginal Cleansing, Procedure: Abdominal CleansingIn the treatment arm, the vagina will be cleansed prior to usual abdominal cleansing before cesarean section. |
| Abdominal Cleansing Alone | Active comparator | Procedure: Abdominal CleansingIn the control arm, abdominal cleansing will be performed per routine with no vaginal cleansing. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women undergoing cesarean delivery after labor at Barnes-Jewish Hospital.
Key exclusion criteria (3 listed)
- Inability to obtain consent
- known or suspected allergy to iodine or shellfish
- women with active herpes simplex virus infection
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 |
|---|---|---|
| Vaginal CleansingThe vagina will be prepped in two passes with sponge sticks soaked in 1% povidone-iodine solution from a prepackaged sterile pouch. | Procedure or surgery | Abdominal and Vaginal Cleansing |
| Abdominal CleansingThe abdomen will be cleansed using chlorhexidine or betadine according to surgeon's preference prior to cesarean. | Procedure or surgery | Abdominal Cleansing Alone, Abdominal and Vaginal Cleansing |
Primary outcome
Composite Postoperative Infectious Morbidity
Time frame: 30 days postoperatively
Maternal fever, endometritis, intrabdominal infection or abscess, wound complication within 30 days of delivery or wound infection.
5 secondary outcomes
Adverse Reaction to Vaginal Cleansing
Time frame: 30 days postoperatively
Length of Hospital Stay
Time frame: 30 days postoperatively
Number of readmissions to hospital for infectious morbidity.
Time frame: 30 days postoperatively
Treatment for neonatal Sepsis
Time frame: 30 days postoperatively
Number of outpatient visits for infectious morbidiy.
Time frame: 30 days postoperatively.
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 6 Aug 2021.
- Derived from this study: PubMed 36462539Temming LA, Frolova AI, Raghuraman N, Tuuli MG, Cahill AG. Vaginal cleansing before unscheduled cesarean delivery to reduce infection: a randomized clinical trial. Am J Obstet Gynecol. 2023 Jun;228(6):739.e1-739.e14. doi: 10.1016/j.ajog.2022.11.1300. Epub 2022 Nov 30.
- 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal Cleansing and Abdominal Cleansing in people with Complications; Cesarean Section, run by Washington University School of Medicine 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 1 inclusion and 3 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 6 Aug 2021. 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.
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?
Composite Postoperative Infectious Morbidity (time frame: 30 days postoperatively). 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 NCT02495753, 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 6 Aug 2021.