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
About this trial
This is an interventional prevention trial for Infection
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
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
NCT ID
NCT04163679
First Posted
November 8, 2019
Last Updated
October 6, 2021
Sponsor
Womack Army Medical Center
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
Mackeen AD, Packard RE, Ota E, Berghella V, Baxter JK. Timing of intravenous prophylactic antibiotics for preventing postpartum infectious morbidity in women undergoing cesarean delivery. Cochrane Database Syst Rev. 2014 Dec 5;(12):CD009516. doi: 10.1002/14651858.CD009516.pub2.
Results Reference
background
PubMed Identifier
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.
Results Reference
result
PubMed Identifier
27682034
Citation
Tita AT, Szychowski JM, Boggess K, Saade G, Longo S, Clark E, Esplin S, Cleary K, Wapner R, Letson K, Owens M, Abramovici A, Ambalavanan N, Cutter G, Andrews W; C/SOAP Trial Consortium. Adjunctive Azithromycin Prophylaxis for Cesarean Delivery. N Engl J Med. 2016 Sep 29;375(13):1231-41. doi: 10.1056/NEJMoa1602044.
Results Reference
result
PubMed Identifier
24657794
Citation
Tuuli MG, Liu L, Longman RE, Odibo AO, Macones GA, Cahill AG. Infectious morbidity is higher after second-stage compared with first-stage cesareans. Am J Obstet Gynecol. 2014 Oct;211(4):410.e1-6. doi: 10.1016/j.ajog.2014.03.040. Epub 2014 Mar 18.
Results Reference
result
PubMed Identifier
28690864
Citation
Kawakita T, Landy HJ. Surgical site infections after cesarean delivery: epidemiology, prevention and treatment. Matern Health Neonatol Perinatol. 2017 Jul 5;3:12. doi: 10.1186/s40748-017-0051-3. eCollection 2017.
Results Reference
result
PubMed Identifier
18165392
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.
Results Reference
result
PubMed Identifier
28796683
Citation
Caissutti C, Saccone G, Zullo F, Quist-Nelson J, Felder L, Ciardulli A, Berghella V. Vaginal Cleansing Before Cesarean Delivery: A Systematic Review and Meta-analysis. Obstet Gynecol. 2017 Sep;130(3):527-538. doi: 10.1097/AOG.0000000000002167.
Results Reference
result
PubMed Identifier
29112658
Citation
Skeith AE, Niu B, Valent AM, Tuuli MG, Caughey AB. Adding Azithromycin to Cephalosporin for Cesarean Delivery Infection Prophylaxis: A Cost-Effectiveness Analysis. Obstet Gynecol. 2017 Dec;130(6):1279-1284. doi: 10.1097/AOG.0000000000002333.
Results Reference
result
PubMed Identifier
23963423
Citation
American College of Obstetricians and Gynecologists Women's Health Care Physicians; Committee on Gynecologic Practice. Committee Opinion No. 571: Solutions for surgical preparation of the vagina. Obstet Gynecol. 2013 Sep;122(3):718-20. doi: 10.1097/01.AOG.0000433982.36184.95.
Results Reference
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PubMed Identifier
11152924
Citation
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Results Reference
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Citation
Dalton E, Castillo E. Post partum infections: A review for the non-OBGYN. Obstet Med. 2014 Sep;7(3):98-102. doi: 10.1177/1753495X14522784. Epub 2014 Feb 27.
Results Reference
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Citation
Zuarez-Easton S, Zafran N, Garmi G, Salim R. Postcesarean wound infection: prevalence, impact, prevention, and management challenges. Int J Womens Health. 2017 Feb 17;9:81-88. doi: 10.2147/IJWH.S98876. eCollection 2017.
Results Reference
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Citation
Haas DM, Morgan S, Contreras K, Enders S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2018 Jul 17;7(7):CD007892. doi: 10.1002/14651858.CD007892.pub6.
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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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