Vaginal Cleansing Before Cesarean Delivery to Reduce Infection

August 5, 2021 updated by: Washington University School of Medicine

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
608

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Barnes Jewish Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women undergoing cesarean delivery after labor at Barnes-Jewish Hospital.

Exclusion Criteria:

  • Inability to obtain consent
  • known or suspected allergy to iodine or shellfish
  • women with active herpes simplex virus infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Abdominal and Vaginal Cleansing
In the treatment arm, the vagina will be cleansed prior to usual abdominal cleansing before cesarean section.
Procedure: Vaginal Cleansing
The vagina will be prepped in two passes with sponge sticks soaked in 1% povidone-iodine solution from a prepackaged sterile pouch.
Procedure: Abdominal Cleansing
The abdomen will be cleansed using chlorhexidine or betadine according to surgeon's preference prior to cesarean.
Active Comparator: Abdominal Cleansing Alone
In the control arm, abdominal cleansing will be performed per routine with no vaginal cleansing.
Procedure: Abdominal Cleansing
The abdomen will be cleansed using chlorhexidine or betadine according to surgeon's preference prior to cesarean.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
30 days postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse Reaction to Vaginal Cleansing
Time Frame: 30 days postoperatively
Hypersensitivity Reaction or more severe allergic reaction
30 days postoperatively
Length of Hospital Stay
Time Frame: 30 days postoperatively
Days in hospital
30 days postoperatively
Number of readmissions to hospital for infectious morbidity.
Time Frame: 30 days postoperatively
Number of times patient is readdmitted for any infectious morbidity.
30 days postoperatively
Treatment for neonatal Sepsis
Time Frame: 30 days postoperatively
Any antibioitics given for neonate with suspected sepsis.
30 days postoperatively
Number of outpatient visits for infectious morbidiy.
Time Frame: 30 days postoperatively.
Number of outpatient or emergency room visits related to infectious morbidity.
30 days postoperatively.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Prespecified Stratified Analysis for Subgroups
Time Frame: 30 days postoperatively
Planned secondary analysis will be aimed at obtaining adjusted assessments of treatment effectiveness with interaction tests used to determine if the effectiveness of vaginal cleansing differs across subgroups. Subgroups include BMI categories, rupture status, chorioamnionitis, stage of labor, cervical dilation >6 cm, gestational age, use of monitors, time in labor, duration of rupture, presence of GBS, labor status, and use of ripening agents.
30 days postoperatively
Prespecified Stratified Analysis for Subgroups
Time Frame: 30 days postoperatively
Planned secondary analysis will be performed in order to obtain adjusted assessment of treatment effectiveness in subgroups stratified based on the following: administration of azithromycin and time of enrolment date in relation to hospital protocol adjustments for Covid19 screening.
30 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201505127

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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