title: Comparison of vaginal misoprostol tablets and prostaglandin E2 gel for the induction of labor in premature rupture of membranes at term: a randomized comparative trial.
abstract: OBJECTIVE
  To compare immediate induction with vaginal misoprostol tablets and immediate induction with vaginal dinoprostone (naturally occurring prostaglandin E2 [PGE2]) gel in women with premature rupture of membranes (PROM) at term.
  
  
  METHODS
  Two hundred and twelve women with PROM at term were assigned randomly to receive either an intravaginal 25 µg misoprostol tablet, 4-hourly, with a maximum of five doses, or 0.5 mg intravaginal PGE2 gel, 6-hourly, with a maximum of two doses. The primary outcome measures were the admission-to-delivery interval and the induction-to-delivery interval. Secondary outcomes included cesarean section rate, mode of delivery, and maternal and neonatal safety outcome. Results were calculated applying Fisher's exact test, χ2-test, t-test and calculating the P-value using an alpha level of 0.05 for Type I errors.
  
  
  RESULTS
  The mean time from admission to delivery was 13.53 h in the misoprostol group and 12.30 h in the PGE2 group (P = 0.090). The induction-to-delivery interval was also comparable between the groups (10.75 h vs. 9.37 h), while the cesarean section rate did not differ significantly between them (7.61% vs. 15.30%). More women in the misoprostol group had an instrumental delivery (12.38% vs. 2.94%). The only significant difference in neonatal outcome was a greater number of babies born with Apgar score < 7 at 1 min in the misoprostol group. Maternal outcomes were not significantly different, except for a higher number of digital vaginal examinations in the misoprostol group.
  
  
  CONCLUSIONS
  Vaginal misoprostol is equally efficacious in labor induction and demonstrates a similar fetal and maternal safety profile to PGE2 gel.
authors.affiliation: Department of Obstetrics and Gynecology, NRS Medical College, Kolkata, West Bengal, India. snehamay_chaudhuri_dr@yahoo.com
authors.forename: Snehamay
authors.initials: S
authors.lastname: Chaudhuri
authors.forename: Sankar Nath
authors.initials: SN
authors.lastname: Mitra
authors.forename: Pradip Kumar
authors.initials: PK
authors.lastname: Banerjee
authors.forename: Pranab Kumar
authors.initials: PK
authors.lastname: Biswas
authors.forename: Sudipta
authors.initials: S
authors.lastname: Bhattacharyya
mesh_terms: D000282:Administration, Intravaginal; D000328:Adult; D036861:Delivery, Obstetric; D015232:Dinoprostone / Q000008:administration & dosage* / Q000627:therapeutic use; D005260:Female; D005322:Premature Rupture of Fetal Membranes / Q000188:drug therapy*; D005782:Gels; D006801:Humans; D007751:Labor, Induced / Q000379:methods*; D016595:Misoprostol / Q000008:administration & dosage* / Q000627:therapeutic use; D010120:Oxytocics / Q000008:administration & dosage* / Q000627:therapeutic use; D011247:Pregnancy; D011256:Pregnancy Outcome; D013607:Tablets; D016896:Treatment Outcome
chemical_list: D005782:Gels; D010120:Oxytocics; D013607:Tablets; D016595:Misoprostol; D015232:Dinoprostone