STRIPES Study: Study To Reduce Infection Post cEsarean Section
NCT ID: NCT02402907
Last Updated: 2020-11-09
Study Results
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View full resultsBasic Information
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COMPLETED
NA
1356 participants
INTERVENTIONAL
2015-04-30
2019-10-11
Brief Summary
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The study will be offered to women who present for a scheduled primary or repeat cesarean section at Mount Sinai Medical Center. The eligible women will be randomized to use of a 2% chlorhexidine gluconate (CHG) cloth or placebo cloth (a fragrance free cleansing cloth) the night before and the morning of their scheduled procedure. Participants will be blinded to the arm in which they have been assigned. This study intends to show that the use of 2% CHG cloths prior to cesarean section will reduce the rate of surgical site infections.
Detailed Description
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All patients with a scheduled cesarean section surgery will be approached for enrollment during their pre-admission testing visit on the labor floor 2 days before the scheduled cesarean section, a visit that is standard procedure for this surgery. Once a patient is consented, she will be randomly assigned to one of the 2 arms of the study: the eligible women will be randomized to use of 2% chlorhexidine gluconate (CHG) cloths or placebo cloths (a fragrance free cleansing cloths) on the body the night before and the morning of their scheduled procedure. Participants will be blinded to the arm in which they have been assigned.
The purpose of this study is to determine if the use of 2% chlorhexidine gluconate cloths prior to cesarean section reduces the rate of surgical site wound infection and/or postpartum endometritis, which is an infection or inflammation of the endometrium (the inner lining of the uterus).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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CHG cloth
2% chlorhexidine gluconate (CHG) cloth
2% chlorhexidine gluconate (CHG) cloth
administration of a 2% CHG cloth at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
Placebo cloth
A fragrance free cleansing cloth
Placebo cloth
administration of a cloth with the placebo (commercial cleansing cloth) at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
Interventions
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2% chlorhexidine gluconate (CHG) cloth
administration of a 2% CHG cloth at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
Placebo cloth
administration of a cloth with the placebo (commercial cleansing cloth) at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* \> 24 weeks gestation
* scheduled for a primary or repeat cesarean section
Exclusion Criteria
* unplanned or emergency cesarean section
18 Years
FEMALE
Yes
Sponsors
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Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Joanne L Stone
Professor
Principal Investigators
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Joanne Stone, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Icahn School of Medicine at Mount Sinai
New York, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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GCO 14-1410
Identifier Type: -
Identifier Source: org_study_id