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At least 19 recordsLinked to original sources
PubMed2006

Induction of labor at term using isosorbide mononitrate simultaneously with dinoprostone compared to dinoprostone treatment alone: a randomized, controlled trial.

OBJECTIVE: We aimed to determine whether isosorbide mononitrate (IMN) given simultaneously with dinoprostone in term pregnancies is superior to dinoprostone alone to promote delivery. STUDY DESIGN: One hundred and twenty nulliparous women at term were randomly assigned to receive per vaginam IMN 40 mg or placebo in addition to 3 mg dinoprostone 2 times daily for up to 2 days. Analysis was by intention to treat. RESULTS: Baseline characteristics of both groups were comparable. The induction to delivery intervals did not differ between the IMN and the placebo group (26.4 +/- 14.4 vs 23.4 +/- 14.8 hours, P = .408). IMN resulted in more headache compared to placebo (32/55 [58.2%] vs 2/55 [3.6%], P < .001). CONCLUSION: Vaginally administered IMN does not play a role in promoting delivery in term pregnancy if given at the same time as dinoprostone. This might reflect its relaxant effect on the uterine fundus, which may overcome its cervical softening effect.

Administration, Intravaginal↗
PubMed2003

Comparative efficacy and cost of the prostaglandin analogs dinoprostone and misoprostol as labor preinduction agents.

OBJECTIVE: The purpose of this study was to compare the relative efficacy and cost of three commercially available prostaglandin analogs, misoprostol (Cytotec), dinoprostone gel (Prepidil), and dinoprostone insert (Cervidil), as labor preinduction agents. STUDY DESIGN: One-hundred eleven women with an unfavorable cervix who underwent labor induction were assigned randomly to receive either misoprostol 50 microg every 6 hours for two doses, dinoprostone gel 0.5 mg every 6 hours for two doses, or dinoprostone insert 10 mg for one dose intravaginally. Twelve hours later, oxytocin induction was initiated per standardized protocol. Efficacy and cost of the labor preinduction/induction with the study treatments were compared. RESULTS: Mean Bishop score change (+/-SD) over the initial 12-hour interval was significantly greater in the misoprostol group (5.2 +/- 3.1) compared with the dinoprostone insert (3.2 +/- 2.3) or the dinoprostone gel groups (2.2 +/- 1.3, P <.0001). The proportion of women who reached complete dilation (68.4%, 50.0%, 51.4%, respectively; P =.14) and who were delivered (60.5%, 47.4%, 40.0%, respectively; P =.10) within 24 hours of the initiation of induction were not significantly different between the misoprostol, dinoprostone insert, and dinoprostone gel groups. Induction-to-delivery intervals, however, were significantly shorter among women who treated with misoprostol (24.0 +/- 10.8 hours) compared with either the dinoprostone gel (31.6 +/- 13.4 hours) or the dinoprostone insert (32.2 +/- 14.7 hours, P <.05). Overall mean cost per patient that was incurred by labor induction was significantly less for the misoprostol group ($1036.13) compared with the dinoprostone insert group ($1565.72) or the dinoprostone gel group ($1572.92, P <.0001). No significant differences were noted with respect to the mode of delivery or to the adverse maternal/neonatal outcome. CONCLUSION: Misoprostol is more cost-effective than the comparable commercial dinoprostone prostaglandin preparations as an adjuvant to labor induction in women with an unfavorable cervix.

Cervical Ripening↗
PubMed2007

Efficacy and safety of six hourly vaginal misoprostol versus intracervical dinoprostone: a randomized controlled trial.

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. CONCLUSION: 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.

Administration, Intravaginal↗
PubMed1997

A comparison of intermittent vaginal administration of misoprostol with continuous dinoprostone for cervical ripening and labor induction.

OBJECTIVE: Our purpose was to compare the effect of vaginal administration of misoprostol (Cytotec) with that of dinoprostone (Cervidil) on cervical ripening and labor induction. STUDY DESIGN: 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. RESULTS: 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. CONCLUSIONS: 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.

Cervix Uteri↗
PubMed2002

Oral and vaginal misoprostol compared with dinoprostone for induction of labor: a randomized controlled trial.

OBJECTIVE: To evaluate the efficacy of oral and vaginal misoprostol compared with the standard regimen using dinoprostone for induction of labor. METHODS: We conducted a multicenter, randomized controlled trial in Cape Town, South Africa. A total of 573 women admitted for induction of labor were randomized to receive oral misoprostol, vaginal misoprostol, or the control, dinoprostone. Misoprostol was given orally or vaginally as a 50-microg dose at 6-hour intervals to a maximum of four doses. The dinoprostone gel was given as a 1-mg dose in the posterior fornix every 6 hours (maximum two doses). RESULTS: There was no significant difference in vaginal delivery rate in 24 hours between the vaginal misoprostol and dinoprostone groups. However, significantly fewer women delivered vaginally in the oral misoprostol group compared with those in the dinoprostone group (relative risk 0.71, 99% confidence interval 0.51, 0.99). The median induction to vaginal delivery time in the vaginal misoprostol, oral misoprostol, and dinoprostone groups was 12 hours, 23 hours, and 14 hours, respectively. The cesarean rate was approximately 33% in all the groups. There were more cesareans performed for fetal distress in the vaginal misoprostol group compared with the dinoprostone group (relative risk 2.86, 99% confidence interval 1.49, 5.46). There was a higher incidence of tachysystole in the vaginal misoprostol group (5.8%) compared with the other two groups: oral misoprostol (0.8%) and dinoprostone (0.8%), but this difference was not statistically significant. There were no differences in maternal or fetal complications. CONCLUSION: Vaginal misoprostol is as effective as dinoprostone in induction of labor, but it is associated with more tachysystole and cesarean sections for fetal distress compared with dinoprostone. Oral misoprostol results in fewer vaginal deliveries in 24 hours, but it is not associated with increased tachysystole or fetal distress.

Administration, Intravaginal↗
PubMed2005

Cardiotocographic abnormalities associated with dinoprostone and misoprostol cervical ripening.

OBJECTIVE: To characterize the frequency and timing of cardiotocographic abnormalities associated with the use of 3 commercially available prostaglandin analogues, misoprostol, dinoprostone gel, and dinoprostone pessary, as labor preinduction agents. METHODS: One-hundred and eleven women undergoing induction of labor with an unfavorable cervix were randomized to receive either misoprostol 50 microg every 6 hours x 2 doses, dinoprostone gel 0.5 mg every 6 hours x 2 doses, or dinoprostone pessary 10 mg x 1 dose for 12 hours intravaginally. Oxytocin induction was initiated per standardized protocol. Cardiotocographic tracings were blindly reviewed, with abnormalities coded using established definitions. RESULTS: Fifty-five percent of women treated with misoprostol demonstrated an abnormal tracing event within the initial 24 hours of induction, compared with 21.1% with dinoprostone pessary and 31.4% with the dinoprostone gel. The mean (+/- standard deviation) number of abnormal events was significantly greater in women treated with misoprostol (5.0 +/- 5.9) versus the dinoprostone pessary (1.6 +/- 2.5) and gel (2.2 +/- 3.1) (P < .05). In addition, these events occurred earlier after initial misoprostol dosing (5.0 +/- 4.0 hours), compared with the dinoprostone pessary (9.4 +/- 5.6 hours) and gel (7.7 +/- 6.6). Thirty-nine percent of the misoprostol-treated women had abnormal patterns within 6 hours of initial dosing, compared with those treated with the dinoprostone pessary (7.9%) and gel (17.1%). CONCLUSION: Cardiotocographic abnormalities are more frequent after misoprostol administration compared with the dinoprostone analogues. The early onset and frequent nature of the tracing abnormalities associated with misoprostol raises concern for the potential use of misoprostol for outpatient cervical ripening.

Adult↗
PubMed1998

Labor induction with prostaglandin E1 misoprostol compared with dinoprostone vaginal insert: a randomized trial.

OBJECTIVE: To compare the safety, efficacy, and costs of intravaginal misoprostol versus dinoprostone vaginal inserts for cervical ripening and labor induction. METHODS: Two hundred twenty-three labor induction patients were assigned randomly to one of two treatment groups: 1) intravaginal misoprostol or 2) dinoprostone vaginal inserts. Fifty micrograms of misoprostol were placed in the posterior vaginal fornix every 3 hours for a maximum period of 24 hours. Ten milligrams of dinoprostone was administered in a single application as a vaginal insert for 12 hours. RESULTS: Among 223 patients evaluated, 108 were allocated to the misoprostol group and 115 to the dinoprostone group. The median interval from induction to vaginal delivery was significantly shorter in the misoprostol group: 698 (range 395-1053) versus 1041 (range 792-1531) minutes (P < .001). Vaginal delivery within 12 hours of ripening occurred in 40.7% of patients who received misoprostol compared with 19.1% for those receiving dinoprostone (P < .001); no significant difference between the groups was noted for vaginal delivery within 24 hours. Uterine tachysystole occurred more frequently in patients in the misoprostol group (21.3%) than in the dinoprostone group (7.0%) (P = .004). Nevertheless, no statistically significant differences were noted between the groups with respect to intrapartum complications, including uterine hyperstimulation, mode of delivery, and neonatal or maternal adverse outcomes. The average cost per patient for misoprostol treatment was $85 compared with $606 for treatment with the vaginal insert. CONCLUSION: Intravaginal misoprostol and the dinoprostone vaginal insert appear to be safe agents for cervical ripening and labor induction. However, misoprostol is less expensive and more effective than the dinoprostone vaginal insert.

Dinoprostone↗
PubMed1999

[Induction of labor in patients with premature rupture of membranes in term pregnancy using dinoprostone vs oxytocin. An aleatory study].

It was accomplished a random comparative study to evaluate the effects of dinoprostone in the Hospital de Gineco Obstetricia No. 60 of the Mexican Institute of the Social Security, from June of 1997 to December of the same year, in relationship to the inducement cervical repening and vaginal delivery in patients with score less than or equal Bishop to 4. They were studied a total of 156 patients split into two groups: 78 patients who were administered by intracervical gel of Dinoprostone and to the remainders 78 were administered oxitocin with the same purpose, being this last the control group. We found that the duration time of induction with dinoprostone is 2 hours in average less than the inducement with oxitocin (p > 0.05). The were achieved 67 deliveries with dinoprostone and 65 deliveries with oxitocina, being not significantly. (p < 0.05) The percentage of inducement defect was considered in relationship to the absence of cervical modifications in 12 hours of administration of dinoprostone or oxitocin, being only 3 patients in each group in these conditions. The observed complications were the same in both groups and the conditions of the newborn were better in the Dinoprostone group. The septic complications of mothers were smaller in Dinoprostone group than Oxitocin group and were significantly (p > 0.05). We can conclude that the dinoprostone intracervical application reduce the induction and expulsion time, with better conditions of the new born, and less percent of infectious complications, in relationship to the Oxitocin control group.

Adult↗
PubMed2006

A randomized comparison of vaginal misoprostol and dinoprostone for cervical priming in nulliparous women before operative hysteroscopy.

OBJECTIVE: To compare the efficacy and side effects of vaginal misoprostol with dinoprostone for cervical priming before operative hysteroscopy and to assess the cervicouterine complications related to cervical dilatation and hysteroscopic surgery. DESIGN: A prospective randomized study. SETTING: Tertiary university hospital. PATIENT(S): Three hundred ten nulliparous women with definite intrauterine lesions. INTERVENTION(S): Hysteroscopic surgery of intrauterine lesions. MAIN OUTCOME MEASURE(S): Cervical response, outcome, complications of hysteroscopic surgery, and side effects of both drugs. RESULT(S): Among the 310 patients recruited, 152 were randomized to the vaginal misoprostol group and 158 to the dinoprostone group. Mean cervical dilatation, cervical dilatation rate, and mean time for cervical dilatation to Hegar 9 were significantly different between the misoprostol group (7.4 +/- 0.8 mm, 70.4%, and 39.5 +/- 18.8 seconds, respectively) and the dinoprostone group (7.0 +/- 0.9 mm, 80.4%, and 43.6 +/- 17.1 seconds, respectively). Cervical tearing during hysteroscopic surgery occurred in 3 patients (2.0%) in the misoprostol group and in 12 patients (7.6%) in the dinoprostone group. There were more side effects in the misoprostol group. The significant difference of side effects between the two groups were abdominal pain, vaginal bleeding, and feeling feverish, which occurred in 36.2%, 29.6%, and 7.2% in the misoprostol group compared to 21.5%, 16.5%, and 1.3%, respectively, in the dinoprostone group. CONCLUSION(S): Vaginal misoprostol is more effective than dinoprostone for cervical priming in nulliparous women before hysteroscopic surgery. Although more side effects occurred in the misoprostol-treated patients, they were mild. We suggest using vagina misoprostol for cervical priming instead of dinoprostone.

Administration, Intravaginal↗
PubMed1999

A randomized comparison of extra-amniotic saline infusion and intracervical dinoprostone gel for cervical ripening.

OBJECTIVE: To compare extra-amniotic saline infusion to intracervical dinoprostone gel for preinduction cervical ripening. METHODS: Women with Bishop scores less than 5 were assigned randomly to either extra-amniotic saline infusion (n = 26) or intracervical dinoprostone gel (n = 26) for preinduction cervical ripening. A sample size of 50 would have 80% power to detect a 10-hour difference in the mean time from start of cervical ripening to delivery for the two methods of intervention, with a type I error of .05. RESULTS: The study populations were similar in age, gestational age, and initial Bishop score. They differed in parity, with 22 nulliparas in the extra-amniotic saline infusion group versus 13 in the dinoprostone gel group (relative risk [RR] 1.69, 95% confidence interval [CI] 1.11, 2.57). The number of women achieving a favorable Bishop score at 6 hours was greater with extra-amniotic saline infusion (n = 20) than dinoprostone gel (n = 9) (RR 2.14, 95% CI 1.22, 3.75). Mean time from start of ripening to delivery was 25.9 hours with extra-amniotic saline infusion and 30.2 hours with dinoprostone gel (P = .25). Birth weight, Apgar scores, umbilical artery pH, and infectious morbidity were similar between groups. CONCLUSION: More women achieved a favorable Bishop score at 6 and 12 hours after the start of cervical ripening with extra-amniotic saline infusion compared with dinoprostone gel. Saline infusion is as safe as dinoprostone gel for preinduction cervical ripening.

Adult↗
PubMed2003

Six hourly vaginal misoprostol versus intracervical dinoprostone for cervical ripening and labor induction.

AIM: Prospective clinical trials were conducted to assess the safety and efficacy of 6-hourly vaginal misoprostol versus intracervical dinoprostone for induction of labor. METHODS: A total of 120 pregnant women requiring induction of labor were recruited. Cases were randomized to receive either 50 microg vaginal misoprostol 6 hourly (group 1, n = 60) or 0.5 mg intracervical dinoprostone 6 hourly (group II, n = 60). Outcome measures, such as change in Bishop's score, need of oxytocin, induction delivery interval; complications like tachysystoly, hyperstimulation, abnormal fetal heart rate, and meconium passage were compared between two groups. Statistical analysis was performed by Wilcoxan's Rank sum and Student's t-test. RESULTS: Bishop score rise, after 6 h of initiation of therapy was significantly higher in the misoprostol group than dinoprostone, 2.98 +/- 2.57 versus 2.05 +/- 1.83 (P = 0.04). The need of oxytocin augmentation was reduced in misoprostol versus dinoprostone group, 16.6% versus 78.3% (P = <0.001). Induction delivery interval was shorter in misoprostol; 12.8 +/- 6.4 h versus 18.53 +/- 8.5 h in dinoprostone group (P = <0.01). One case (1.6%) in misoprostol group, but none in dinoprostone had tachystole (P = 1.00). Abnormal heart rate pattern was found more in misoprostol than dinoprostone 16.6% versus 4.9% (P = 0.14) and so was the incidence of cesarean section, 26.6 versus 15%, respectively (P = 0.47). Meconium passage was the same in both groups, 10% in each group. CONCLUSION: Vaginal misoprostol 50 microg 6-hourly is safe and effective for induction of labor with lesser need of oxytocin augmentation and shorter induction delivery interval.

Administration, Intravaginal↗
PubMed2005

Outpatient misoprostol compared with dinoprostone gel for preinduction cervical ripening: a randomized controlled trial.

OBJECTIVE: To determine whether a single outpatient dose of intravaginal misoprostol (versus intracervical dinoprostone gel) reduces the oxytocin use for induction. Despite the numerous trials examining misoprostol for induction, the efficacy of a single outpatient dose of misoprostol followed by oxytocin induction is unknown. METHODS: Patients with a term, vertex, singleton pregnancy and a Bishop score of 6 or less were randomly assigned to receive misoprostol (n = 42, 0.25 microg intravaginally) or dinoprostone gel (n = 42, 0.5 mg intracervically) the evening before oxytocin induction. Patients were monitored for 3 hours after administration and discharged to home if fetal assessment was reassuring, for readmission the next morning for oxytocin. Primary outcomes were oxytocin dose, time, and dose intensity (dose divided by duration). Secondary outcomes were incidence of labor, uterine hyperstimulation, cesarean delivery, Apgar score. Statistics used were chi(2), Student t test, Mann-Whitney rank sum test, and Fisher exact test. P < .05 was accepted as statistically significant. RESULTS: A single dose of misoprostol significantly decreased the cumulative dose of oxytocin, the cumulative time of oxytocin administration, and the dose intensity of oxytocin (dose divided by time). Data are as follows (mean +/- standard error of the mean): oxytocin dose-dinoprostone 10,929 +/- 219 mU, misoprostol 6,081 +/- 170 mU, P = .008; oxytocin time-dinoprostone 798 +/- 11 minutes, misoprostol 531 +/- 11 minutes, P = .009; dose intensity-dinoprostone 11.3 +/- 0.1 mU/min, misoprostol 7.4 +/- 0.2 mU/min, P = .003. Misoprostol induced labor during the ripening period in 19 of 41 of patients, compared with 6 of 42 after dinoprostone (P = .002). There was no difference in cesarean delivery (dinoprostone, 8/42; misoprostol, 9/42; P = 1.00). There was no difference in short-term neonatal outcome. No patient had hyperstimulation or required cesarean delivery for nonreassuring fetal assessment during the ripening period. CONCLUSION: A single dose of misoprostol administered in the outpatient setting significantly decreases oxytocin use, largely due to labor within the ripening period.

Administration, Intravaginal↗
PubMed1999

Cervical ripening and labor induction with a controlled-release dinoprostone vaginal insert: a meta-analysis.

OBJECTIVE: To systematically review published randomized trials that compared efficacy of a 10-mg, controlled-release dinoprostone vaginal insert with other prostaglandins for cervical ripening and labor induction. DATA SOURCES: We supplemented a search of entries in electronic databases with references cited in original studies and review articles to identify randomized clinical trials of dinoprostone vaginal inserts for cervical ripening and labor induction. METHODS OF STUDY SELECTION: We evaluated, abstracted data, and assessed the quality of randomized clinical trials on the efficacy of dinoprostone vaginal inserts as cervical ripening and labor induction agents. Only published randomized trials were included in this meta-analysis. TABULATION, INTEGRATION, AND RESULTS: Seventeen studies were identified, eight of which met our criteria for metaanalysis. Those eight trials included 964 subjects, 490 of whom were allocated to dinoprostone vaginal inserts and 474 to other prostaglandin (PG) preparations. We calculated an estimate of the odds ratio (OR) and risk difference for dichotomous outcomes, using a random- and fixed-effects model. Continuous outcomes were pooled using a variance-weighted average of within-study difference in means. Compared with women who received other PG preparations, those who received dinoprostone vaginal inserts had lower incidence of vaginal delivery within 12 hours of PG application (OR 0.55, 95% confidence interval 0.39, 0.79). Vaginal inserts were associated with longer intervals to vaginal delivery and lower rates of active labor. There were no differences in cesarean delivery rates, incidence of hyperstimulation, or need for oxytocin augmentation between dinoprostone and other PGs. CONCLUSION: Dinoprostone vaginal insert was less effective than other prostaglandins for cervical ripening and labor induction.

Administration, Intravaginal↗
PubMed2000

A randomized comparison of one single dose of vaginal 50 microg misoprostol with 3 mg dinoprostone in pre-induction cervical ripening.

OBJECTIVE: To compare the efficacy and safety of one single dose of 50 pg misoprostol to one single dose of 3 mg dinoprostone administered vaginally for pre-induction cervical ripening in term-pregnant women, who had indications for induction of labor with unripe cervices. STUDY DESIGN: A randomized double-blind controlled trial. SETTING: Bangkok Metropolitan Administration Medical College and Vajira Hospital, Bangkok, Thailand. SUBJECTS: One hundred and forty-three singleton pregnant women of > or = 37 weeks of gestation, who had indications for termination of pregnancy. All patients had a Bishop score of 0-6, without contraindications for labor induction. INTERVENTION: The subjects were stratified by parity to nullipara and multipara group. The subjects in each stratum were allocated by randomization to receive a single dose of 50 microg misoprostol or 3 mg dinoprostone, administered vaginally. Twenty-four hours after medication, oxytocin augmentation was given to both groups. MAIN OUTCOME MEASURE: The Bishop score of cervix at 24 hours after insertion of the studied drugs, the occurrence of abnormal uterine contraction, and the number of vaginal deliveries within 24, 48 hours. RESULTS: The demographic data and the initial Bishop score (median score 3.5 versus 4.0) were comparable in both groups. The change of score at 24 hours was one unit higher in misoprostol-treated patients compared with dinoprostone-treated patients (mean change score 6.5 versus 5.5, with 95 per cent CI 0.04 to 2.1, p=0.042) but was not of clinical importance. There was a higher frequency of hyperstimulation syndrome in the misoprostol group (6.9% vs 0%) during 8 hours of cervical ripening. Although the difference was not statistically significant (p=0.058), it was clinically important. Comparing vaginal deliveries between the misoprostol and dinoprostone groups, the frequencies of delivery within 24 hours were 46.3 per cent versus 35.7 per cent (p=0.350), and within 48 hours were 88.9 per cent versus 89.3 per cent (p>0.05), non-significantly different. No significant differences were noted between misoprostol and dinoprostone in terms of interval from start of medication to vaginal delivery and neonatal outcomes. CONCLUSION: The efficacy of a single 50 microg dose of vaginally administered misoprostol, is not clinically different to 3 mg dinoprostone in cervical ripening. Although the study was not sufficiently large to detect the differences in abnormal uterine contractions between the two groups, there was a higher frequency of hyperstimulation syndrome in the misoprostol group compared to the dinoprostone group. Close utero-fetal monitoring in misoprostol-treated patients is needed.

Adolescent↗
PubMed2006

Intravaginal glyceryl trinitrate and dinoprostone for cervical ripening and induction of labor.

OBJECTIVE: This study was undertaken to evaluate the efficacy and safety of intravaginal administration of glyceryl trinitrate plus dinoprostone versus dinoprostone, for cervical ripening and induction of labor. STUDY DESIGN: A prospective, double-blind, placebo-controlled, randomized clinical trial was conducted among 196 singleton low-risk nullipara women with term pregnancies and unfavorable cervices who were randomly assigned to receive intravaginal glyceryl trinitrate plus dinoprostone or placebo plus dinoprostone. The main outcome variables were time from application to active phase of labor and to delivery. Secondary outcomes were change in Bishop score, fetal and maternal morbidity, and incidence of cesarean deliveries. RESULTS: The interval from application of the initial dose to the beginning of active phase of labor was 868 +/- 582 and 1136 +/- 692 minutes (P = .004) and from initial dose to delivery was 1339 +/- 826 and 1620 +/- 975 minutes (P = .03) for the glyceryl trinitrate and placebo groups, respectively. There were no significant differences in Bishop score change, cesarean section rate, and in the incidence of hypersystole and hyperstimulation. The incidence of tachysystole was significantly lower in the glyceryl trinitrate group (4% vs 15%, P < or = .02). No maternal and neonatal adverse effects were noted. CONCLUSION: The association of glyceryl trinitrate with dinoprostone is more effective than dinoprostone alone for labor induction in low-risk patients at term with unfavorable cervices.

Administration, Intravaginal↗
PubMed2003

Misoprostol and dinoprostone therapy for labor induction: a Doppler comparison of uterine and fetal hemodynamic effects.

OBJECTIVE: To compare the effect of misoprostol (PGE(1)) versus dinoprostone (PGE(2)) on blood flow in uteroplacental circulation during labor induction. STUDY DESIGN: Eighty-four women with indications for induction of labor were assigned to receive either misoprostol 50 microg per vagina every 4 h as needed or 0.5 mg doses of dinoprostone given intra-cervically every 6 h by means of a randomization table generated by computer. Doppler velocimetry of umbilical, uterine and arcuate arteries was performed immediately before and 2-3 h after the administration of misoprostol or dinoprostone. The SAS system was used to perform statistical analysis. RESULTS: There were no significant changes of pulsatility index (PI), resistance index (RI) and systolic/diastolic (S/D) ratio in umbilical arteries after both prostaglandin compounds. Vaginal application of misoprostol significantly increased all ratios in arcuate artery and S/D ratio in uterine artery. Intra-cervically dinoprostone significantly increased PI, RI and S/D ratio in arcuate and uterine arteries. CONCLUSIONS: Our results indicate that vaginal misoprostol and cervical dinoprostone administration increases uteroplacental resistance but does not affect umbilical blood flow. Misoprostol would be as safe and effective agent as dinoprostone for cervical ripening and labor induction.

Blood Flow Velocity↗
PubMed2004

A randomised trial comparing low dose vaginal misoprostol and dinoprostone for labour induction.

OBJECTIVE: To compare vaginal misoprostol with dinoprostone for induction of labour. DESIGN: Randomised multicentre trial. SETTING: Labour wards of one university hospital and two teaching hospitals. POPULATION: Six hundred and eighty-one women with indication for labour induction at >or=36 weeks of gestation, singleton pregnancy and no previous ceasarean section. METHODS: Misoprostol (25 mcg, hospital-prepared capsule) in the posterior vaginal fornix, every four hours, maximum three times daily or dinoprostone gel (1 mg) every four hours. Oxytocin was administered if necessary. MAIN OUTCOME MEASURES: Primary: 'adverse neonatal outcome' (5-minute Apgar score <7 and/or umbilical cord pH <7.15). Secondary: labour duration, mode of delivery and patient satisfaction. RESULTS: Three hundred and forty-one women received misoprostol and 340 dinoprostone. The median induction-delivery interval was longer in the misoprostol group compared with the dinoprostone group (25 versus 19 hours, P= 0.008). The caesarean section rate was lower in the misoprostol group: 16.1%versus 21%, but this difference was not statistically significant RR = 0.8 (95% CI 0.6-1.04). 'Adverse neonatal outcome' was found to be similar in both groups: 21% in the misoprostol and 23% in the dinoprostone groups. Significantly fewer neonates were admitted to NICU in the misoprostol group compared with dinoprostone 19%versus 26% (RR = 0.7, 95% CI 0.5-0.98). CONCLUSIONS: Misoprostol in this dosing regimen is a safe method of labour induction. NICU admission rates were lower in the misoprostol group. No difference could be detected in patient satisfaction between groups.

Administration, Intravaginal↗