title: Association of 17α-Hydroxyprogesterone Caproate and Risk of Infection.
abstract: OBJECTIVE
  To evaluate whether exposure to 17α-hydroxyprogesterone caproate is associated with the rate of peripartum infection in women who deliver preterm and their neonates.
  
  
  METHODS
  This is a retrospective cohort study of patients who delivered before 37 weeks of gestation at a tertiary care hospital between July 1, 2005, and December 31, 2012. Women in the case group (women exposed to 17α-hydroxyprogesterone caproate) were matched to women in a control group (unexposed patients) by gestational age and delivery date. The primary outcome was a composite infection rate comprising histologic or clinical chorioamnionitis, endometritis, or early-onset neonatal sepsis. To detect a 15% difference in composite infection rate between women exposed to 17α-hydroxyprogesterone caproate and those unexposed (two-tailed α=0.05 and power=80%), 183 patients per group were required. Logistic regression was performed to control for a history of prior spontaneous preterm birth and exposure to betamethasone.
  
  
  RESULTS
  The primary outcome frequency for women exposed to 17α-hydroxyprogesterone caproate was 34.6% (64 patients) compared with 33% (61 patients) in those unexposed (P=.74). There was no significant difference between women exposed to 17α-hydroxyprogesterone caproate and those unexposed in frequency of clinical chorioamnionitis (1.9% compared with 1.1%, P=.66), histologic chorioamnionitis (39.4% compared with 40%, P=.92), or early-onset neonatal sepsis (2.7% compared with 1.1%, P=.28). A total of 7.1% of women exposed to 17α-hydroxyprogesterone caproate developed endometritis compared with 2.7% of those unexposed (P=.05). The adjusted odds ratio for the primary outcome in women exposed to 17α-hydroxyprogesterone caproate was 0.65 (95% confidence interval 0.31-1.38).
  
  
  CONCLUSIONS
  Exposure to 17α-hydroxyprogesterone caproate does not increase the risk of peripartum infection among women who deliver preterm or their neonates.
  
  
  METHODS
  II.
authors.affiliation: Women & Infants Hospital of Rhode Island/Warren Alpert Medical School of Brown University, Providence, Rhode Island.
authors.forename: Alexandra D
authors.initials: AD
authors.lastname: Mainiero
authors.forename: Dwight J
authors.initials: DJ
authors.lastname: Rouse
authors.forename: Vrishali
authors.initials: V
authors.lastname: Lopes
authors.forename: Brenna L
authors.initials: BL
authors.lastname: Hughes
mesh_terms: D000077713:17 alpha-Hydroxyprogesterone Caproate; D000328:Adult; D002821:Chorioamnionitis / Q000139:chemically induced* / Q000453:epidemiology; D015331:Cohort Studies; D004716:Endometritis / Q000139:chemically induced* / Q000453:epidemiology; D005260:Female; D006801:Humans; D006908:Hydroxyprogesterones / Q000009:adverse effects* / Q000627:therapeutic use; D007231:Infant, Newborn; D016015:Logistic Models; D011247:Pregnancy; D047928:Premature Birth / Q000517:prevention & control*; D011372:Progestins / Q000009:adverse effects* / Q000627:therapeutic use; D012189:Retrospective Studies; D012307:Risk Factors; D018805:Sepsis / Q000139:chemically induced* / Q000453:epidemiology; D016896:Treatment Outcome
chemical_list: D006908:Hydroxyprogesterones; D011372:Progestins; D000077713:17 alpha-Hydroxyprogesterone Caproate