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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal Preparation | Experimental | 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. |
|
| Standard Infection Procedures | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal Preparation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Infection rates | wound infection | Six weeks postpartum |
| Infection rates | endometritis | six weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Infant Birth Weight | record their birth weight (gm) | Four weeks after birth |
| Infant Apgar scores | Apgar scores | Four weeks after birth |
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Inclusion Criteria:
Exclusion Criteria:
Azithromycin contraindicated:
Pregnant females admitted to Womack Army Medical Center who deliver full term via unscheduled, non-emergent cesarean section following labor
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Womack Army Medical Center | Fort Bragg | North Carolina | 28310 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25479008 | Background | 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. | |
| 22866185 | Result | 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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| ID | Term |
|---|---|
| D007239 | Infections |
| D007744 | Obstetric Labor Complications |
| D004716 | Endometritis |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000292 | Pelvic Inflammatory Disease |
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| Infant Length of hospital stay | Hospital stay (days) | Four weeks after birth |
| Numbers of Infants admitted to NICU | Infant admission to neonatal intensive care unit | four weeks after birth |
| Number of Infants that develop respiratory distress | The infant acquiring the condition of respiratory distress | Four weeks after birth |
| Number of Infants that develop sepsis | Infant acquiring sepsis | Four weeks after birth |
| Number of infants that die | Infant death | Four weeks after birth |
| 27682034 | Result | 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. |
| 24657794 | Result | 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. |
| 28690864 | Result | 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. |
| 18165392 | Result | 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. |
| 25350672 | Result | 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. |
| 28796683 | Result | 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. |
| 29112658 | Result | 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. |
| 23963423 | Result | 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. |
| 11152924 | Result | 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. |
| 27512432 | Result | 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. |
| 28255256 | Result | 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. |
| 30016540 | Result | 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. |
| Result | 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. |
| Result | 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. |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D014591 | Uterine Diseases |
| D000091662 | Genital Diseases |