Vaginal Preparation and Azithromycin to Reduce Post Cesarean Infections
NCT ID: NCT04163679
Last Updated: 2021-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
84 participants
INTERVENTIONAL
2019-09-18
2021-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Vaginal Preparation
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.
Vaginal Preparation
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.
Standard Infection Procedures
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.
Vaginal Preparation
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.
Interventions
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Vaginal Preparation
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.
Eligibility Criteria
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Inclusion Criteria
* undergoing labored, non-emergent cesarean section
* patient in labor
Exclusion Criteria
* 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
18 Years
64 Years
FEMALE
Yes
Sponsors
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Womack Army Medical Center
FED
Responsible Party
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Karen L Wilson
Program Director of Obstetrics and Gynecology Residency Chief of Maternal Fetal Medicine and Obstetrics Chief
Locations
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Womack Army Medical Center
Fort Bragg, North Carolina, United States
Countries
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References
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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;2014(12):CD009516. doi: 10.1002/14651858.CD009516.pub2.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Reid VC, Hartmann KE, MCMahon M, Fry EP. Vaginal preparation with povidone iodine and postcesarean infectious morbidity: a randomized controlled trial. Obstet Gynecol. 2001 Jan;97(1):147-52. doi: 10.1016/s0029-7844(00)01087-5.
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.
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.
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.
Kawakita T, Iqbal SN, Desale S, Fries M. Decrease in surgical site infection after cesarean delivery by implementing surgical bundle. Am J Obstet Gynecol 2018; 218:S323-S323.
Guzman MA, Prien SD, Blann DW. Post-cesarean related infection and vaginal preparation with povidone-iodine revisited. Prim Care Update Ob Gyns 2002; 9:206-209.
Other Identifiers
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RHC-A-19-033
Identifier Type: -
Identifier Source: org_study_id
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