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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03133312
Other study ID # VAGPrep
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 2, 2017
Est. completion date December 30, 2017

Study information

Verified date March 2019
Source Metro Health, Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Primary Hypothesis: chlorhexidine gluconate antiseptic vaginal preparation is superior to povidone-iodine vaginal preparation in decreasing the bacterial load within the vagina when prepping prior to a cesarean section.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Chlorhexidine Gluconate
Pre-operative vaginal preparation with 4% Chlorhexidine Gluconate Intervention
Povidone-Iodine Scrub and Paint
Pre-operative vaginal preparation with 10% Povidone-Iodine Scrub and Paint Intervention

Locations

Country Name City State
United States Metro Health Wyoming Michigan

Sponsors (1)

Lead Sponsor Collaborator
Metro Health, Michigan

Country where clinical trial is conducted

United States, 

References & Publications (4)

Culligan PJ, Kubik K, Murphy M, Blackwell L, Snyder J. A randomized trial that compared povidone iodine and chlorhexidine as antiseptics for vaginal hysterectomy. Am J Obstet Gynecol. 2005 Feb;192(2):422-5. — View Citation

Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 1 — View Citation

Levin I, Amer-Alshiek J, Avni A, Lessing JB, Satel A, Almog B. Chlorhexidine and alcohol versus povidone-iodine for antisepsis in gynecological surgery. J Womens Health (Larchmt). 2011 Mar;20(3):321-4. doi: 10.1089/jwh.2010.2391. Epub 2011 Feb 16. — View Citation

Tuuli MG, Liu J, Stout MJ, Martin S, Cahill AG, Odibo AO, Colditz GA, Macones GA. A Randomized Trial Comparing Skin Antiseptic Agents at Cesarean Delivery. N Engl J Med. 2016 Feb 18;374(7):647-55. doi: 10.1056/NEJMoa1511048. Epub 2016 Feb 4. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Post-Operative Infection Presence of post-operative infection including endometritis, pelvic abscess, and skin/wound up to 30 day post-operative
Primary Bacterial Load Change in total bacterial load from baseline (pre-operative) vaginal culture Immediately Post-operative prior to exit from operating room
Secondary Length of Hospital Stay Number of days 2 or 3 post-operative days
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