Efficacy and safety of six hourly vaginal misoprostol versus intracervical dinoprostone: a randomized controlled trial.
ABSTRACT To compare the efficacy and safety of intravaginal misoprostol versus dinoprostone cervical gel for cervical ripening and labour induction.
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.
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.
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.
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ABSTRACT: Our purpose was to compare the effect of vaginal administration of misoprostol (Cytotec) with that of dinoprostone (Cervidil) on cervical ripening and labor induction. Two hundred patients with indications for induction of labor and unfavorable cervical examinations were randomly assigned to receive vaginally administered misoprostol (prostaglandin E1) or the dinoprostone (prostaglandin E2) vaginal insert. Twenty-five microgram tablets of misoprostol were placed in the posterior vaginal fornix every 4 hours for a maximum of six doses. Additional misoprostol was not given after either spontaneous rupture of membranes, adequate cervical ripening (Bishop score of > or = 8 or cervical dilatation of > or = 3 cm), or beginning of active labor. The vaginal insert, Cervidil, containing 10 mg of dinoprostone in a timed-release preparation was placed in the posterior vaginal formix for a maximum period of 24 hours. The vaginal insert was removed for spontaneous rupture of membranes, entry into active labor, adequate cervical ripening, or abnormality of uterine contractile pattern or fetal cardiac activity. Of the 200 patients enrolled, 99 were randomized to misoprostol and 101 to dinoprostone. The average interval from start of induction to vaginal delivery was 1 hour shorter in the misoprostol group (1296.7 +/- 722.1 minutes) than in the dinoprostone group (1360.0 +/- 792.0 minutes), but this difference was not statistically significant (p = 0.97). Oxytocin augmentation of labor was used in 50 (50.5%) misoprostol-treated patients and 43 (43.5%) dinoprostone-treated patients (relative risk 1.14, 95% confidence interval 0.86 to 1.51, p = 0.35). There were no significant differences between routes of delivery with misoprostol or dinoprostone. Overall, 38 patients (19.3%) had cesarean deliveries. There was a significantly lower prevalence of tachysystole (six or more uterine contractions in a 10-minute window for two consecutive 10-minute periods) in the misoprostol group (7.1%) than in the dinoprostone group (18.4%) (relative risk 0.52, 95% confidence interval 0.31 to 0.89, p = 0.02). There were no significant differences in frequency of uterine hyperstimulation or hypertonus. Abnormal fetal heart rate tracings were found in 23 (23.2%) of misoprostol-treated patients and 35 (35.7%) of dinoprostone-treated patients (relative risk 0.73, 95% confidence interval 0.52 to 1.01, p = 0.0546). No significant differences were found in meconium passage, 1- or 5-minute Apgar scores < 7, neonatal resuscitations, or admissions to the neonatal intensive care unit between the two groups. Vaginally administered misoprostol is as effective as dinoprostone for cervical ripening and the induction of labor. Mean time intervals to delivery, need for oxytocin augmentation, and routes of delivery were similar between the two groups. Incidence of uterine tachysystole with misoprostol every 4 hours was significantly less than with dinoprostone.American Journal of Obstetrics and Gynecology 09/1997; 177(3):612-8. · 3.88 Impact Factor
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ABSTRACT: Misoprostol (prostaglandin E1) compares favorably with dinoprostone (prostaglandin E2) and oxytocin for labor induction at term. Excessive uterine activity has been reported using high-dose regimens, but no negative effect on outcomes has been observed. Labor was induced in a 34-year-old multipara at 39 weeks' gestation using intravaginal misoprostol tablets. Five hours after administration of the second 25-microgram dose, fetal bradycardia prompted emergency cesarean delivery. Hysterectomy and left salpingo-oophorectomy were necessary to control bleeding from a 15-cm posterior uterine wall rupture. Misoprostol can cause excessive uterine activity and uterine rupture.Obstetrics and Gynecology 06/1997; 89(5 Pt 2):832-3. · 4.80 Impact Factor
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ABSTRACT: The aim of this randomized controlled study was to compare the efficacy and the safety of different regimens of misoprostol for labor induction. MATERIALS AND METHODS Eligible women received intravaginal 100 microg, every 6 h or 50 microg every 4 h. Treatment continued until: (1) dilatation >3 cm; (2) rupture of membranes (artificial); (3) signs of uterine hyperstimulation; (4) adequate contraction pattern (three contraction/10 min). Managing clinician might use oxytocin during labor. Cesarean section rate was the main outcome that was considered variably. Other outcome measures were neonatal outcome (Apgar scores, meconium staining, and umbilical artery pH) and induction to delivery interval. A total number of 72 women received either misoprostol 100 microg (n=37), or 50 microg (n=35) randomly. The two groups had similar mean Bishops scores at induction (4.10+/-2.4 versus 4.2+/-2.1; P=0.85), rates of nulliparity, use of epidural anesthesia, and oxytocin augmentation. In two groups the number of doses of misoprostol used was similar (1.6+/-0.5 versus 1.7+/-0.3) There was not any difference between the two groups in the mean+/-S.D. time to delivery (h) and cesarean rate. Likewise, there was not a significance between two groups in the rates of 5 min Apgar score, and of meconium passage.European Journal of Obstetrics & Gynecology and Reproductive Biology 03/2004; 113(1):41-4. · 1.84 Impact Factor