title: Efficacy and safety of six hourly vaginal misoprostol versus intracervical dinoprostone: a randomized controlled trial.
abstract: OBJECTIVE
  To compare the efficacy and safety of intravaginal misoprostol versus dinoprostone cervical gel for cervical ripening and labour induction.
  
  
  METHODS
  We carried out an experimental clinical trial in which we enrolled 130 cervical consecutive patients with cervical ripening, randomly assigned to one of the following two treatment groups: (1) intravaginal misoprostol and (2) intracervical dinoprostone gel. A total of 50 microm of misoprostol was placed in the posterior vaginal fornix every 6 h for a maximum period of 24 h and 0.5 mg of dinoprostone was administrated in the uterine cervix every 6 h, for a maximum period of 24 h. The primary outcome measure was the number (rate) of women who went to vaginally deliver within 24 h of the protocol initiation.
  
  
  RESULTS
  Among 130 patients evaluated, 65 were allocated to the misoprostol group and 65 to the dinoprostone group. The proportion of vaginal delivery within 24 h was significantly higher in the misoprostol group (75%) than in the dinoprostone group (53.8%) (RR = 1.40, 95% CI [1.07-1.45], P = 0.02). There was no significant difference between the mean time interval of delivery in the misoprostol group and the dinoprostone group (14.9 vs.15.8 h) (P = 0.51). The Bishop score was significantly higher in the misoprostol group, 6 h after the onset of the study (1.38; relative risk, 95% CI [1.02-1.85], P = 0.03). The Caesarean delivery rate for fetal distress was higher in the dinoprostone group (21 vs. 10.8%, P = 0.15). The tachysystole (Misoprostol 6.1% vs. dinoprostone 4.6%, relative risk 1.15, 95% CI [0.6-2.24]) and hyperstimulation syndrome rates (Misoprostol 7.6% vs. dinoprostone 4.6%, relative risk 1.26, 95% CI [0.72-2.24]) were slightly increased in the misoprostol group than in the dinoprostone group without reaching the level of statistical signification.
  
  
  CONCLUSIONS
  Misoprostol as used in this protocol is more effective than cervical dinoprostone gel application in the cervical ripening and labour induction. There is a tendency for an increase in the rate of tachysystole and hyperstimulation syndrome.
authors.affiliation: University Hospital Fattouma Bourguiba, Unit of Obstetrics and Gynaecology, 5000 Monastir, Tunisia. walid.denguezli@rns.tn
authors.forename: Walid
authors.initials: W
authors.lastname: Denguezli
authors.forename: Adnene
authors.initials: A
authors.lastname: Trimech
authors.forename: Anis
authors.initials: A
authors.lastname: Haddad
authors.forename: Awatef
authors.initials: A
authors.lastname: Hajjaji
authors.forename: Zahra
authors.initials: Z
authors.lastname: Saidani
authors.forename: Raja
authors.initials: R
authors.lastname: Faleh
authors.forename: Mohamed
authors.initials: M
authors.lastname: Sakouhi
mesh_terms: D000282:Administration, Intravaginal; D000287:Administration, Topical; D000328:Adult; D020070:Cervical Ripening / Q000187:drug effects*; D036861:Delivery, Obstetric / Q000379:methods; D015232:Dinoprostone / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007751:Labor, Induced / Q000379:methods*; D016595:Misoprostol / Q000008:administration & dosage* / Q000009:adverse effects; D010120:Oxytocics / Q000008:administration & dosage* / Q000009:adverse effects; D011247:Pregnancy
chemical_list: D010120:Oxytocics; D016595:Misoprostol; D015232:Dinoprostone