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Vaginal Preparation and Azithromycin to Reduce Post Cesarean Infections

Primary Purpose

Infection, Obstetric Labor Complications, Endometritis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vaginal Preparation
Sponsored by
Womack Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infection

Eligibility Criteria

18 Years - 64 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • full term pregnancy
  • undergoing labored, non-emergent cesarean section
  • patient in labor

Exclusion Criteria:

Azithromycin contraindicated:

  • Known hypersensitivity to azithromycin, erythromycin, macrolides or ketolide medications.
  • liver dysfunction
  • Prescription medications which may interact with azithromycin, such as nelfinavir or warfarin
  • A history of a cardiac dysrhythmia (irregular heartbeats)
  • Known hypersensitivity to iodine
  • Patients carrying fetuses with known congenital anomalies
  • Immunodeficiency
  • Patients who are not in labor at the time of delivery
  • Non-english speaking subjects or subjects with language barriers

Sites / Locations

  • Womack Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Vaginal Preparation

Standard Infection Procedures

Arm Description

In addition to standard care, subjects will undergo vaginal preparation (VP). A VP kit includes sponge sticks and sponges soaked in a povidone-iodine 10% solution.

The very staff will follow hospital protocols for the cesarean delivery. The subject and the infant will be provided care in accordance with current medical standards and be discharged at the discretion of the attending physician.

Outcomes

Primary Outcome Measures

Infection rates
wound infection
Infection rates
endometritis

Secondary Outcome Measures

Infant Birth Weight
record their birth weight (gm)
Infant Apgar scores
Apgar scores
Infant Length of hospital stay
Hospital stay (days)
Numbers of Infants admitted to NICU
Infant admission to neonatal intensive care unit
Number of Infants that develop respiratory distress
The infant acquiring the condition of respiratory distress
Number of Infants that develop sepsis
Infant acquiring sepsis
Number of infants that die
Infant death

Full Information

First Posted
November 8, 2019
Last Updated
October 6, 2021
Sponsor
Womack Army Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04163679
Brief Title
Vaginal Preparation and Azithromycin to Reduce Post Cesarean Infections
Official Title
Combining Vaginal Preparation and Azithromycin in Reduction of Post Cesarean Infections: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Enrollment issues
Study Start Date
September 18, 2019 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
July 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Womack Army Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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Detailed Description
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6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Obstetric Labor Complications, Endometritis, Cesarean Delivery Affecting Fetus, Wounds Injuries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vaginal Preparation
Arm Type
Experimental
Arm Description
In addition to standard care, subjects will undergo vaginal preparation (VP). A VP kit includes sponge sticks and sponges soaked in a povidone-iodine 10% solution.
Arm Title
Standard Infection Procedures
Arm Type
Sham Comparator
Arm Description
The very staff will follow hospital protocols for the cesarean delivery. The subject and the infant will be provided care in accordance with current medical standards and be discharged at the discretion of the attending physician.
Intervention Type
Procedure
Intervention Name(s)
Vaginal Preparation
Intervention Description
One sponge stick will be inserted into the vagina, where it will stay during the scrubbing of thighs and genitals. One sponge will be used to scrub the right inner thigh from mid-thigh to right labia majora. This sponge will then be discarded. A second sponge will be used to scrub the left inner thigh from mid-thigh to left labia majora. This sponge will then be discarded. A third sponge will be used to scrub the mons pubs, labia majora and minor, perineum and rectum in that order then will be discarded. This will be repeated with a fourth sponge. The existing sponge stick in the vagina will be rotated in the vagina twice then removed. This will be discarded. A second sponge stick will be inserted in the vagina, rotated twice then removed. As it is removed from the vagina, the perineum and rectum will be swabbed with the stick in that order then discarded. This will be repeated using a third sponge stick.
Primary Outcome Measure Information:
Title
Infection rates
Description
wound infection
Time Frame
Six weeks postpartum
Title
Infection rates
Description
endometritis
Time Frame
six weeks postpartum
Secondary Outcome Measure Information:
Title
Infant Birth Weight
Description
record their birth weight (gm)
Time Frame
Four weeks after birth
Title
Infant Apgar scores
Description
Apgar scores
Time Frame
Four weeks after birth
Title
Infant Length of hospital stay
Description
Hospital stay (days)
Time Frame
Four weeks after birth
Title
Numbers of Infants admitted to NICU
Description
Infant admission to neonatal intensive care unit
Time Frame
four weeks after birth
Title
Number of Infants that develop respiratory distress
Description
The infant acquiring the condition of respiratory distress
Time Frame
Four weeks after birth
Title
Number of Infants that develop sepsis
Description
Infant acquiring sepsis
Time Frame
Four weeks after birth
Title
Number of infants that die
Description
Infant death
Time Frame
Four weeks after birth

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant females admitted to Womack Army Medical Center who deliver full term via unscheduled, non-emergent cesarean section following labor
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: full term pregnancy undergoing labored, non-emergent cesarean section patient in labor Exclusion Criteria: Azithromycin contraindicated: Known hypersensitivity to azithromycin, erythromycin, macrolides or ketolide medications. liver dysfunction Prescription medications which may interact with azithromycin, such as nelfinavir or warfarin A history of a cardiac dysrhythmia (irregular heartbeats) Known hypersensitivity to iodine Patients carrying fetuses with known congenital anomalies Immunodeficiency Patients who are not in labor at the time of delivery Non-english speaking subjects or subjects with language barriers
Facility Information:
Facility Name
Womack Army Medical Center
City
Fort Bragg
State/Province
North Carolina
ZIP/Postal Code
28310
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25479008
Citation
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Results Reference
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22866185
Citation
Conroy K, Koenig AF, Yu YH, Courtney A, Lee HJ, Norwitz ER. Infectious morbidity after cesarean delivery: 10 strategies to reduce risk. Rev Obstet Gynecol. 2012;5(2):69-77.
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27682034
Citation
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Results Reference
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PubMed Identifier
24657794
Citation
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Results Reference
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PubMed Identifier
28690864
Citation
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Results Reference
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PubMed Identifier
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Citation
Tita AT, Hauth JC, Grimes A, Owen J, Stamm AM, Andrews WW. Decreasing incidence of postcesarean endometritis with extended-spectrum antibiotic prophylaxis. Obstet Gynecol. 2008 Jan;111(1):51-6. doi: 10.1097/01.AOG.0000295868.43851.39.
Results Reference
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PubMed Identifier
25350672
Citation
Smaill FM, Grivell RM. Antibiotic prophylaxis versus no prophylaxis for preventing infection after cesarean section. Cochrane Database Syst Rev. 2014 Oct 28;2014(10):CD007482. doi: 10.1002/14651858.CD007482.pub3.
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PubMed Identifier
28796683
Citation
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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Citation
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Vaginal Preparation and Azithromycin to Reduce Post Cesarean Infections

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