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Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial

Primary Purpose

Cesarean Section, Endometritis, Surgical Wound Infection

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vaginal cleansing before cesarean delivery
Sponsored by
Indiana University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cesarean Section focused on measuring Povidone iodine, postoperative infection, presurgical cleansing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Woman undergoing cesarean delivery
  • At least 18 years of age

Exclusion Criteria:

  • Allergy to iodine containing solutions
  • Planned cesarean hysterectomy
  • Prisoner

Sites / Locations

  • Methodist Hospital
  • University Hospital
  • Wishard Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vag prep

Arm Description

Vagina cleansed prior to performing cesarean

Outcomes

Primary Outcome Measures

Number of Participants Who Experienced Composite Endometritis Plus Wound Complications.
Endometritis was diagnosed clinically as uterine pain and fever requireing antibiotics. Wound complications included wound infection, seroma, hematoma, or separation.

Secondary Outcome Measures

Full Information

First Posted
October 9, 2006
Last Updated
January 14, 2010
Sponsor
Indiana University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00386477
Brief Title
Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial
Official Title
Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Terminated
Why Stopped
Difficulty recruiting
Study Start Date
September 2006 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Indiana University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of the project is to find out whether cleansing the vagina before a cesarean delivery decreases the risk of complications and infections after having the baby. If this is the case, cleansing the vagina before cesarean delivery can help improve outcomes for many women and make their early postpartum recovery much more pleasant, giving a healthier start for the family.
Detailed Description
Infectious morbidity frequently complicates cesarean delivery. Endometritis can complicate the postoperative course of a cesarean delivery 6-27% of the time. This complication, up to 10 times more frequent than after vaginal delivery, can lead to serious complications. Additionally, cesarean deliveries are frequently complicated by maternal fever and wound complications including seroma, hematoma, infection, and separation. These morbidities can lead to significant delay in a return to normal function. Our study will randomize 1000 women who are about to undergo a cesarean delivery into one of two groups. The control group will receive the standard surgical preparation of the abdomen alone, the current standard pre-cesarean preparation. The other group will also receive a povidone iodine washing/scrub of the vagina before the cesarean delivery. Maternal and surgical variables will be recorded. At one months postpartum, maternal outpatient data will be reviewed and the incidence of postpartum uterine infection, wound separations, and other wound and infectious complications will be determined and compared between the two treatment groups. Comparison: Women receiving standard surgical abdominal cleansing versus women receiving standard abdominal and preoperative vaginal cleansing before cesarean delivery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section, Endometritis, Surgical Wound Infection
Keywords
Povidone iodine, postoperative infection, presurgical cleansing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vag prep
Arm Type
Experimental
Arm Description
Vagina cleansed prior to performing cesarean
Intervention Type
Procedure
Intervention Name(s)
Vaginal cleansing before cesarean delivery
Other Intervention Name(s)
1% betadine scrub of vagina with vaginal scrub spongesticks.
Intervention Description
Cleansing vagina with 1% betadine scrub before cesarean.
Primary Outcome Measure Information:
Title
Number of Participants Who Experienced Composite Endometritis Plus Wound Complications.
Description
Endometritis was diagnosed clinically as uterine pain and fever requireing antibiotics. Wound complications included wound infection, seroma, hematoma, or separation.
Time Frame
1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Woman undergoing cesarean delivery At least 18 years of age Exclusion Criteria: Allergy to iodine containing solutions Planned cesarean hysterectomy Prisoner
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Haas, MD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Wishard Memorial Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32335895
Citation
Haas 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.
Results Reference
derived
PubMed Identifier
20207251
Citation
Haas DM, Pazouki F, Smith RR, Fry AM, Podzielinski I, Al-Darei SM, Golichowski AM. Vaginal cleansing before cesarean delivery to reduce postoperative infectious morbidity: a randomized, controlled trial. Am J Obstet Gynecol. 2010 Mar;202(3):310.e1-6. doi: 10.1016/j.ajog.2010.01.005.
Results Reference
derived

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Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial

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