title: Comparison of 25 µg sublingual and 50 µg intravaginal misoprostol for cervical ripening and labor: a randomized controlled equivalence trial.
abstract: BACKGROUND
  Sublingual misoprostol, used for labor induction, produces earlier and higher peak plasma concentrations of misoprostol than vaginal or rectal misoprostol. The sublingual route could be expected to be more effective and safer than the vaginal route and by avoiding a direct effect on the cervix, it might reduce the risk of uterine hyperstimulation and be safer. This study aimed to compare the efficacy of 25-µg sublingual misoprostol with 50-µg intravaginal misoprostol for cervical ripening prior to labor induction in primiparous women.
  
  
  METHODS
  In a double-blind, parallel randomized controlled equivalence trial, we recruited 131 primiparous women at 36-42 weeks of gestation requiring labor induction who referred to Alzahara hospital in Rasht, Iran. The women were randomly assigned to receive 25-µg sublingual misoprostol with vaginal placebo (n = 63) or 50-µg intravaginal misoprostol with sublingual placebo (n = 63). The dose was repeated every 4 h (maximum 4 doses). The primary outcome was the interval from the start of induction to vaginal delivery.
  
  
  RESULTS
  There were no significant differences between the two groups with regard to the interval from the start of induction to vaginal delivery(13.2 ± 3.07 h in the vaginal group vs. 13.1 ± 3.46 h in the sublingual group), duration of active phase, Bishop Scores after 4h, and rate of the vaginal delivery under 12 h. Also, the rate of hyperstimulation, tachysystole, type of delivery, cause of cesarean section, Apgar scores less than 7 and admission to the NICU were similar in these two groups. The mean dose of misoprostol applied was significantly lower in the sublingual group (P = 0.001).
  
  
  CONCLUSIONS
  Sublingual administration of 25-µg of misoprostol appears to be as effective as 50 µg intravaginal misoprostol for cervical ripening and labor induction.
  
  
  BACKGROUND
  This trial has been registered under IRCT 38903131096N3.
authors.affiliation: Reproductive Health Research Center, Guilan university of Medical Sciences, Guilan, Iran.forozanmilani@yahoo.com.
authors.forename: Seyedeh Hajar
authors.initials: SH
authors.lastname: Sharami
authors.affiliation: Reproductive Health Research Center, Guilan university of Medical Sciences, Guilan, Iran.
authors.forename: Forozan
authors.initials: F
authors.lastname: Milani
authors.affiliation: Reproductive Health Research Center, Guilan university of Medical Sciences, Guilan, Iran.
authors.forename: Roya
authors.initials: R
authors.lastname: Faraji
authors.affiliation: Department of Neonatology, Guilan University of Medical Sciences, Guilan, Iran.
authors.forename: Kobra
authors.initials: K
authors.lastname: Bloukimoghadam
authors.affiliation: Vice-chancellorship Guilan University of Medical Sciences, Guilan, Iran.
authors.forename: Fatemeh
authors.initials: F
authors.lastname: Salamat
authors.affiliation: Reproductive Health Research Center, Guilan university of Medical Sciences, Guilan, Iran.
authors.forename: Salma
authors.initials: S
authors.lastname: Momenzadeh
authors.affiliation: Reproductive Health Research Center, Guilan university of Medical Sciences, Guilan, Iran.
authors.forename: Hanan
authors.initials: H
authors.lastname: Ebrahimi
mesh_terms: D000282:Administration, Intravaginal; D000286:Administration, Sublingual; D000328:Adult; D020070:Cervical Ripening / Q000187:drug effects*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007751:Labor, Induced / Q000379:methods*; D016595:Misoprostol / Q000008:administration & dosage* / Q000627:therapeutic use; D011247:Pregnancy; D011256:Pregnancy Outcome; D055815:Young Adult
chemical_list: D016595:Misoprostol