Clinical trial NCT04163679: Vaginal Preparation and Azithromycin to Reduce Post Cesarean Infections
Official title: Combining Vaginal Preparation and Azithromycin in Reduction of Post Cesarean Infections: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infection
Obstetric Labor Complications
Endometritis
Cesarean Delivery Affecting Fetus
Wounds Injuries
Lead sponsor: Womack Army Medical Center
Sponsor class: FED
First posted: 2019-11-15
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: asdgf

Detailed description: asdf

Eligibility criteria: 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

Primary outcomes:
measure: Infection rates
timeFrame: Six weeks postpartum
measure: Infection rates
timeFrame: six weeks postpartum
Secondary outcomes:
measure: Infant Birth Weight
timeFrame: Four weeks after birth
measure: Infant Apgar scores
timeFrame: Four weeks after birth
measure: Infant Length of hospital stay
timeFrame: Four weeks after birth
measure: Numbers of Infants admitted to NICU
timeFrame: four weeks after birth
measure: Number of Infants that develop respiratory distress
timeFrame: Four weeks after birth
measure: Number of Infants that develop sepsis
timeFrame: Four weeks after birth
measure: Number of infants that die
timeFrame: Four weeks after birth
Other outcomes:
Locations:
city: Fort Bragg
country: United States
facility: Womack Army Medical Center
state: North Carolina
Study officials:
References:
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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 Med. 2016 Sep 29;375(13):1231-41. doi: 10.1056/NEJMoa1602044.
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citation: 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.
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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.
citation: 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.
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