Infection Clinical Trial
Official title:
Combining Vaginal Preparation and Azithromycin in Reduction of Post Cesarean Infections: A Randomized Controlled Trial
Verified date | October 2021 |
Source | Womack Army Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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Status | Terminated |
Enrollment | 84 |
Est. completion date | July 30, 2021 |
Est. primary completion date | July 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 64 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Womack Army Medical Center | Fort Bragg | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Womack Army Medical Center |
United States,
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 — View 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. Review. — View 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. — View 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. — View Citation
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.
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:CD007892. doi: 10.1002/14651858.CD007892.pub6. Review. Update — View Citation
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.
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. Review. — View 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. Review. — View Citation
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. — View 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. — View Citation
Smaill FM, Grivell RM. Antibiotic prophylaxis versus no prophylaxis for preventing infection after cesarean section. Cochrane Database Syst Rev. 2014 Oct 28;(10):CD007482. doi: 10.1002/14651858.CD007482.pub3. Review. — View 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. — View 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 M — View 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. — View 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. Review. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Infection rates | wound infection | Six weeks postpartum | |
Primary | Infection rates | endometritis | six weeks postpartum | |
Secondary | Infant Birth Weight | record their birth weight (gm) | Four weeks after birth | |
Secondary | Infant Apgar scores | Apgar scores | Four weeks after birth | |
Secondary | Infant Length of hospital stay | Hospital stay (days) | Four weeks after birth | |
Secondary | Numbers of Infants admitted to NICU | Infant admission to neonatal intensive care unit | four weeks after birth | |
Secondary | Number of Infants that develop respiratory distress | The infant acquiring the condition of respiratory distress | Four weeks after birth | |
Secondary | Number of Infants that develop sepsis | Infant acquiring sepsis | Four weeks after birth | |
Secondary | Number of infants that die | Infant death | Four weeks after birth |
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