Vaginal Preparation and Azithromycin to Reduce Post Cesarean Infections

Infection Clinical Trial

Official title:

Combining Vaginal Preparation and Azithromycin in Reduction of Post Cesarean Infections: A Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04163679
• Other study ID #: RHC-A-19-033
• Status: Terminated
• Phase: N/A
• Start date: September 18, 2019
• Est. completion date: July 30, 2021

Study information

• Verified date: October 2021
• Source: Womack Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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Description:

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Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cesarean Delivery Affecting Fetus
• Communicable Diseases
• Endometritis
• Infection
• Infections
• Obstetric Labor Complications
• Wounds Injuries

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Womack Army Medical Center	Fort Bragg	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Womack Army Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (16)

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

Outcome

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