Oral misoprostol or vaginal dinoprostone for labor induction: a randomized controlled trial

OBJECTIVE: The objective of the study was to compare the effectiveness, safety, and side effects of low-dose oral misoprostol with vaginal dinoprostone for cervical ripening and labor induction. STUDY DESIGN: Women with Bishop score 6 or less admitted for labor induction at term were eligible for this randomized controlled trial. Exclusion criteria were multiple pregnancy, breech, fetal distress, or previous uterine scar. The allocation to the oral misoprostol group (20 microg given every 2 hours increased to 40 microg depending on uterine contractions) or to the vaginal dinoprostone group (2 mg twice, 6 hours apart) was contained in a sealed, opaque, and consecutively numbered envelope. RESULTS: Two hundred women (100 in each group) were included. The proportion of vaginal delivery within 24 hours was 56% in the misoprostol group and 62% in the dinoprostone group (relative risk 0.90, 95% CI 0.72-1.14). The risk of cesarean section was 18% and 19%, respectively. The median interval to delivery, calculated from survival analysis, was longer in the misoprostol group (1305 minutes) compared with the dinoprostone group (1080 minutes). The log-rank test was not significant (P =.35). Uterine hyperstimulation occurred in 9% of women in the misoprostol group compared with 14% in the dinoprostone group (P =.27). The only significant difference in neonatal outcomes was a more frequent presence of thick meconium in the misoprostol group (P =.03). CONCLUSION: We found no difference in terms of effectiveness and safety between low-dose oral misoprostol and vaginal dinoprostone used for induction of labor. This regimen avoids the excessive uterine contractility noted in previous studies, where higher doses of misoprostol were administered at longer intervals.     

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 ≥8 or cervical dilatation of ≥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 fornix 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.     

Efficacy and safety of misoprostol compared with the dinoprostone for labor induction at term: a meta-analysis

Objective: The purpose of this study was to compare the efficacy and safety of intravaginal misoprostol and the dinoprostone vaginal insert for labor induction at term.

Method: PubMed, EMBASE, MEDLINE, CNKI, EBSCO and the Cochrane Library were searched for articles published in English language from 2000 to 2014, Using the keywords misoprostol, dinoprostone, labor induction.

Results: Eight of 436 studies (1669 women) identified met the criteria for meta-analysis. We assigned a quality rating to each included article. The use of misoprostol showed less oxytocin augmentation when compared with dinoprostone (RR?=?0.78, 95% CI?=?0.67–0.90). There was no difference in the risk of tachysystole (RR?=?1.18, 95% CI?=?0.78–1.79), uterine hyperstimulation (RR?=?1.24, 95% CI?=?0.75–2.06), vaginal delivery within 24?h (RR?=?1.10, 95% CI?=?1.00–1.20), cesarean delivery (RR?=?0.84, 95% CI?=?0.56–1.24), Neonatal Intensive Care Unit admission (RR?=?0.86, 95% CI?=?0.58–1.28), Apgar scores <7 in 5?min (RR?=?1.18, 95% CI?=?0.39–3.63) between misoprostol and dinoprostone.

Conclusion: Misoprostol compared with dinoprostone appears to show less oxytocin augmentation for labor induction at term. The other outcomes of both drugs were similar. However, these findings were based on small-scale trials. Further studies assessing the effectiveness and safety of misoprostol and dinoprostone in selected groups of patients are warranted.     

Titrated oral compared with vaginal misoprostol for labor induction: a randomized controlled trial

OBJECTIVE: To compare the efficacy and safety of titrated oral misoprostol and vaginal misoprostol for labor induction. METHODS: Women between 34 and 42 weeks of gestation with an unfavorable cervix (Bishop score less than or equal to 6) and an indication for labor induction were randomLy assigned to receive titrated oral or vaginal misoprostol. The titrated oral misoprostol group received a basal unit of 20 mL misoprostol solution (1 mcg/mL) every 1 hour for four doses and then were titrated against individual uterine response. The vaginal group received 25 mcg every 4 hours until attaining a more favorable cervix. Vaginal delivery within 12 hours was the primary outcome. The data were analyzed by intention-to-treat. RESULTS: Titrated oral misoprostol was given to 101 (48.8%) women and vaginal misoprostol to 106 (51.2%) women. Completed vaginal delivery occurred within 12 hours in 75 (74.3%) women in the titrated oral group and 27 (25.5%) women in the vaginal group (relative risk [RR] 8.44, 95% confidence interval [CI] 4.52-15.76). The incidence of hyperstimulation was 0.0% in the titrated oral group compared with 11.3% in the vaginal group (RR 0.08, 95% CI 0.01-0.61). Although more women experienced nausea (10.9%) in the titrated oral group (RR 27.07, 95% CI 1.57-465.70), fewer infants had Apgar scores of less than 7 at 1 minute in the titrated oral group than in the vaginal group (RR 0.10, 95% CI 0.01-0.76). CONCLUSION: Titrated oral misoprostol is associated with a lower incidence of uterine hyperstimulation and a lower cesarean delivery rate than vaginal misoprostol for labor induction in patients with unfavorable cervix. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00529295 LEVEL OF EVIDENCE: I.     

Oral versus vaginal misoprostol for induction of labor: a double-blind randomized controlled trial

OBJECTIVE: To determine the efficacy of oral misoprostol (50 microg) administered every 3 hours compared to vaginal misoprostol (50 microg) administered every 6 hours for induction of labor. STUDY DESIGN: In this double-blind randomized trial, 126 women received misoprostol (50 microg) either orally every 3 hours or vaginally every 6 hours for induction of labor. Outcomes included time from induction to delivery, oxytocin augmentation, incidence of hyperstimulation and tachysystole, mode of delivery, and neonatal outcomes. RESULTS: Median time to delivery was shorter in those women who were receiving vaginal misoprostol (vaginal 14.3 hours vs oral 23.1 hours; P =.0004) and more women in the oral group required oxytocin augmentation of labor (73% vs 42%) (RR, 1.98; 95% CI, 1.29 to 3.06). The incidence of hyperstimulation was similar between the groups, but there was an increased incidence of tachysystole in the vaginal group (26.5% vs 9.7%)(RR, 2.74; 95% CI, 1.16 to 6.51). There was no difference between the groups with respect to mode of delivery or neonatal outcome. CONCLUSION: Vaginal misoprostol administered every 6 hours is more effective for induction of labor than oral misoprostol administered every 3 hours. The higher rates of tachysystole with use of vaginal misoprostol in the current study warrant further investigation.     

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.     

A prospective randomized study comparing misoprostol and oxytocin for premature rupture of membranes at term.

OBJECTIVE: The aim of this randomized trial was to compare the efficacy and safety of vaginal misoprostol and oxytocin for cervical ripening and labor induction in patients with premature rupture of membrane (PROM) at term. METHODS: Ninety-seven women with PROM at term were assigned randomly to receive intravaginal misoprostol or oxytocin. The primary outcome measure was the induction-delivery interval. Secondary outcomes included the number of women who delivered vaginally within 12 hours of the start of the induction in the two groups, the cesarean, hyperstimulation, and failed induction rates, the mode of delivery, and the neonatal outcome. RESULTS: Forty-eight women were assigned to intravaginal misoprostol and 49 to oxytocin administration. The mean interval from induction to delivery was 10.61 +/- 2.45 hours in the misoprostol group and 11.57 +/- 1.91 hours in the oxytocin group (p = 0.063). The rates of vaginal delivery were 83.3% and 87.7% and cesarean delivery were 16.7% and 8.2% in the misoprostol and oxytocin groups, respectively. Neonatal outcomes were not significantly different. Of the cases, 8.3% in the misoprostol group and 8.2% in the oxytocin group revealed uterine contraction abnormalities. CONCLUSION: Our study demonstrates that, intravaginally, misoprostol results in a similar interval from induction of labor to delivery when compared to oxytocin.     

Misoprostol for induction of labour at term: a more effective agent than dinoprostone vaginal gel.

OBJECTIVE: To compare the efficacy of vaginal misoprostol and dinoprostone vaginal gel for induction of labour at term. DESIGN: A single-blind randomised comparative trial. SETTING: Induction and labour wards of a UK teaching hospital. PARTICIPANTS: Two hundred and eleven pregnant women at term in whom induction of labour was indicated, and with no contra-indication to the use of prostaglandins for the induction of labour. INTERVENTION: The women were randomly assigned to receive vaginal administration of either misoprostol 50 microg four hourly (to a maximum of four doses) or dinoprostone gel 1 mg six hourly (to a maximum of three doses). MAIN OUTCOME MEASURES: Time from induction to delivery, oxytocin requirement in labour, analgesic requirement, mode of delivery, neonatal outcome. RESULTS: The misoprostol group had a highly significant reduction in median induction-delivery interval compared with the dinoprostone group (14.4 hours vs 22.9 hours; P < 0.00001). In addition, more women delivered after only one dose (77% vs 49%; P < 0.0001, OR 3.51, 95% CI 1.94-6.35), and within 12 and 24 hours. There was a reduced need for oxytocin augmentation in labour (21% vs 47%; P < 0.0001, OR 0.30, 95% CI 0.16-0.54). There was no difference in analgesia requirement in labour, or in mode of delivery. There were no adverse neonatal outcomes associated with the use of misoprostol. Women in the misoprostol group experienced more pain in the interval between induction and being given analgesia in labour, but this did not reach statistical significance. CONCLUSIONS: Misoprostol 50 microg vaginally is a more effective induction agent than 1 mg dinoprostone vaginal gel, with no apparent adverse effects on mode of delivery, or on the fetus. The higher pain scores in the misoprostol group must be balanced against the reduction in time spent having labour induced, and the reduction in need for intravenous oxytocin augmentation. Further randomised studies must continue to exclude the possibility of rare adverse side effects.     

Oral, vaginal and sublingual misoprostol for induction of labor.

OBJECTIVE: To evaluate the effectiveness and safety of different administration routes of misoprostol for induction of labor. METHOD: PubMed, Cochrane Library and EMBASE searches were carried out using the keywords oral, vaginal, sublingual, buccal, misoprostol, labor induction, identifying randomized case-controlled trials comparing different routes for giving misoprostol to induce labor, published in English between 1994 and 2004. RESULTS: Seventeen studies (3549 participants) were included. Compared to vaginal administration, oral misoprostol was associated with higher failure rates for achieving vaginal delivery within 24 h (odds ratio (OR) 1.61, 95% confidence interval (CI) 1.23-2.10), higher rates of uterine hyperstimulation without fetal heart rate (FHR) changes (OR 2.21, 95% CI 1.12-4.34) and lower cesarean section rates (OR 0.74, 95% CI 0.56-0.97). A lower dose of oral misoprostol (50 microg) compared to the 25-50 microg administered vaginally was associated with a higher rate of vaginal delivery not being achieved within 24 h (OR 3.60, 95% CI 2.10-6.18), more need for oxytocin augmentation (OR 2.19, 95% CI 1.65-2.92), less uterine hyperstimulation both without FHR changes (OR 0.58, 95% CI 0.42-0.80) and with FHR changes (OR 0.34, 95% CI 0.17-0.67) and fewer cesarean sections (OR 0.69, 95% CI 0.51-0.91). Compared to vaginal administration, buccal misoprostol resulted in a higher rate of failure to achieve vaginal delivery after 24 h, more frequent uterine hyperstimulation and lower rates of cesarean section, but these differences were not significant. When 50 mug of misoprostol used sublingually was compared to oral administration, the sublingual misoprostol was associated with less failure to achieve vaginal delivery after 24 h, less oxytocin augmentation and reduced cesarean section, but none of the differences were statistically significant. CONCLUSIONS: Vaginal misoprostol appears more effective than the equivalent dosage administered orally. However, the vaginal route appears to be associated with a higher risk of uterine hyperstimulation. Sublingual misoprostol seems an effective route of administration, but a lack of data necessitates more clinical trials to establish the effectiveness and safety of the buccal/sublingual route.     

Induction of labor: the misoprostol controversy

Misoprostol (Cytotec) is safe and effective for induction of labor, although it is not approved by the Food and Drug Administration (FDA) for use in pregnancy. In August 2000, the manufacturer of misoprostol warned against its use in pregnancy because of its abortifacient properties and cited reports of maternal and fetal deaths when misoprostol was used to induce labor, fueling the misoprostol controversy. More than 45 randomized trials including more than 5400 women have found vaginal misoprostol to be more effective than oxytocin or vaginal prostaglandin E2 at effecting vaginal delivery within 24 hours. Cesarean delivery rates with vaginal misoprostol are lower than with oxytocin alone, but similar to prostaglandin E2. There have been no significant differences in the frequency of serious adverse maternal or neonatal outcomes with low-dose misoprostol compared with oxytocin or prostaglandin E2; however, the relative risk of rare adverse outcomes with misoprostol is unknown. The data suggest that absolute risks are low when misoprostol is used appropriately. We recommend 25 mcg vaginally every 4 to 6 hours for carefully selected patients in closely monitored settings. Whether misoprostol will prove to be the most cost-effective agent for inducing labor in women with an unfavorable cervix remains to be determined.     

Labor induction in preeclampsia: is misoprostol more effective than dinoprostone?

OBJECTIVE: To compare the efficacy of vaginal misoprostol versus dinoprostone for induction of labor (IOL) in patients with preeclampsia according to the WHO criteria. STUDY DESIGN: Ninety-eight patients were retrospectively analyzed. A total of 47 patients received 3 mg dinoprostone suppositories every 6 h (max. 6 mg/24 h) whereas 51 patients in the misoprostol group received either 50 mug misoprostol vaginally every 12 h, or 25 mug every 6 h (max. 100 mug/24 h). Primary outcomes were vaginal delivery within 24 and 48 h, respectively. RESULTS: The probability of delivering within 48 h was more than three-fold higher in the misoprostol than in the dinoprostone group: odds ratio (OR)=3.48; 95% confidence interval (CI) 1.24, 10.30, whereas no significant difference was observed within 24 h (P=0.34). No correlation was seen between a ripe cervix prior to IOL and delivery within 24/48 h (P=0.33 and P=1.0, respectively). More cesarean sections were performed in the dinoprostone group due to failed IOL (P=0.0009). No significant differences in adverse maternal outcome were observed between both study groups, whereas more neonates (12 vs. 6) of the dinoprostone group were admitted to the NICU (P=0.068). CONCLUSION: This study suggests that misoprostol may have some advantages compared to dinoprostone, including improved efficacy and lower cost of the drug, even in cases of preeclampsia.     

A prospective randomized study comparing misoprostol and oxytocin for premature rupture of membranes at term

Objective.?The aim of this randomized trial was to compare the efficacy and safety of vaginal misoprostol and oxytocin for cervical ripening and labor induction in patients with premature rupture of membrane (PROM) at term.

Methods.?Ninety-seven women with PROM at term were assigned randomly to receive intravaginal misoprostol or oxytocin. The primary outcome measure was the induction–delivery interval. Secondary outcomes included the number of women who delivered vaginally within 12 hours of the start of the induction in the two groups, the cesarean, hyperstimulation, and failed induction rates, the mode of delivery, and the neonatal outcome.

Results.?Forty-eight women were assigned to intravaginal misoprostol and 49 to oxytocin administration. The mean interval from induction to delivery was 10.61 ± 2.45 hours in the misoprostol group and 11.57 ± 1.91 hours in the oxytocin group (p = 0.063). The rates of vaginal delivery were 83.3% and 87.7% and cesarean delivery were 16.7% and 8.2% in the misoprostol and oxytocin groups, respectively. Neonatal outcomes were not significantly different. Of the cases, 8.3% in the misoprostol group and 8.2% in the oxytocin group revealed uterine contraction abnormalities.

Conclusion.?Our study demonstrates that, intravaginally, misoprostol results in a similar interval from induction of labor to delivery when compared to oxytocin.     

A comparison of orally administered misoprostol with vaginally administered misoprostol for cervical ripening and labor induction.

OBJECTIVE: Our purpose was to compare orally administered with vaginally administered misoprostol for cervical ripening and labor induction. MATERIAL AND METHODS: Two hundred twenty subjects with medical or obstetric indications for labor induction and undilated, uneffaced cervices were randomly assigned to receive orally administered or vaginally administered misoprostol. Fifty micrograms of oral misoprostol or 25 microgram of vaginal misoprostol was given every 4 hours. If cervical ripening (Bishop score of >/=8 or cervical dilatation of >/=3) or active labor did not occur, repeated doses were given to a maximum of 6 doses or 24 hours. Thereafter, oxytocin was administered intravenously by a standardized incremental infusion protocol to a maximum of 22 mU/min. RESULTS: Of the 220 subjects evaluated, 110 received orally administered misoprostol and 110 received vaginally administered misoprostol. Fewer subjects who received the oral preparation (34/110, 30.9%) were delivered vaginally within 24 hours of initiation of induction, in comparison with those who received the vaginal preparation (52/110, 47.3%) (P =.01). The average interval from start of induction to vaginal delivery was nearly 6 hours longer in the oral treatment group (mean and SD 1737.9 +/- 845.7 minutes) than in the vaginal treatment group (mean and SD 1393.2 +/- 767.9) (P =.005, log-transformed data). Orally treated patients required significantly more doses than vaginally treated patients (orally administered doses: mean and SD 3.3 +/- 1.7; vaginally administered doses: mean and SD 2.3 +/- 1.2) (P <.0001). Oxytocin administration was necessary in 83 (75.4%) of 110 orally treated subjects and in 65 (59.1%) of 110 vaginally treated subjects (P =.01, relative risk 1. 28, 95% confidence interval 1.06-1.54). Vaginal delivery occurred in 95 (86.4%) orally treated subjects and in 85 (77.3%) vaginally treated subjects (P =.08, relative risk 1.12, 95% confidence interval 0.99-1.27), with the remainder undergoing cesarean delivery. There was no difference in the incidence of uterine contractile abnormalities (tachysystole, hypertonus, or hyperstimulation), intrapartum complications, or neonatal outcomes between the 2 groups. CONCLUSIONS: Oral administration of 50-microgram doses of misoprostol appears less effective than vaginal administration of 25-microgram doses of misoprostol for cervical ripening and labor induction. Further investigation is needed to determine whether orally administered misoprostol should be used for cervical ripening and labor induction.     

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 μm 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.     

Oral misoprostol (100 microg) versus vaginal misoprostol (25 microg) in term labor induction: a randomized comparison

OBJECTIVE: To compare the efficacy of vaginal misoprostol (25 microg) to oral misoprostol (100 microg) in labor induction at term. METHODS: One hundred and one women at term, with indications for labor induction and cervical Bishop's scores of less than 8, were randomly assigned to receive 100 microg of oral misoprostol or 25 microg vaginal misoprostol after random allocation. This could be repeated every 4 h to a maximum of five doses. The number delivering vaginally within 24 h of the induction was the main outcome measure. RESULTS: Of those who delivered vaginally (74.5% in the oral group vs. 72% in the vaginal group), significantly fewer women delivered within 24 h of induction in the oral group (42.1% vs. 72.2%, RR 0.6, 95% CI 0.4-0.9), with more women receiving more than one dose (45.7% vs. 16.7%, RR 2.7, 95% CI 1.2-6.0). More women in the oral group received oxytocin (68.6% vs. 44%, RR 1.6, 95% CI 1.1-2.2), and the induction to delivery interval was shorter in the vaginal group, although this was not statistically significant [28.9 h (SD 20.2) vs. 20.6 h (SD 16.1), mean difference - 8.3 h, 95% CI - 16.8 to 0.2]. There were no differences in the modes of delivery, uterine hyperstimulation rates or in the neonatal outcomes. CONCLUSION: Vaginal misoprostol in its currently recommended dose of 25 microg seems to be more efficacious than the 100 microg oral dose.     

Abruptio placentae associated with misoprostol use in women with preeclampsia

OBJECTIVE: To evaluate complications associated with cervical ripening with vaginal administration of misoprostol and dinoprostone vaginal inserts in women with preeclampsia. preeclampsia. STUDY DESIGN: Retrospective study of patients with preeclampsia undergoing cervical ripening with vaginal misoprostol and dinoprostone vaginal inserts prior to labor induction. RESULTS: Among 203 patients with preeclampsia undergoing cervical ripening prior to induction, 95 received vaginal misoprostol, and 108 received dinoprostone. The incidence of uterine hyperstimulation requiring medical therapy and the need for emergency cesarean section due tofetal heart rate abnormalities were significantly higher among patients receiving misoprostol (22.1% versus 12.0%, p = 0.04, and 17.9% versus 8.3%, p = 0.03, respectively). The overall incidence of abruptio placentae was 7.4%, with a significantly higher incidence among those receiving misoprostol as compared to dinoprostone (13.7% versus 1.9%, p = 0.001). CONCLUSION: Among patients with preeclampsia undergoing cervical ripening prior to labor induction, there is a higher incidence of acute intrapartum complications (uterine hyperstimulation, cesarean section for fetal heart rate abnormalities and abruptio placentae) with vaginal misoprostol, as compared to dinoprostone, vaginal insert.     

Excessive uterine activity accompanying induced labor

OBJECTIVE: To estimate the incidence and timing of excessive uterine activity accompanying induction of labor with misoprostol using different routes (oral or vaginal) and forms (intact tablet or crushed) and to compare these with dinoprostone gel, oxytocin, and spontaneous labor. METHODS: This retrospective cohort study included 519 women at term who had labor induced and 86 women at term in spontaneous labor. Induction agents included misoprostol, dinoprostone, or oxytocin. Fetal heart rate and uterine activity tracings were analyzed independently by three maternal-fetal medicine physicians. The diagnosis of tachysystole or hyperstimulation required the agreement of two or more reviewers. RESULTS: The incidence of tachysystole was highest with misoprostol administered by vaginal tablet (misoprostol vaginal tablet 50 microg every 4 hours, 48.6%; vaginal tablet crushed 50 microg and suspended in hydroxyethyl gel every 4 hours, 30.7%, P =.009; oral tablet 50 microg every 4 hours, 22.2%, P =.001; oral tablet crushed 50 microg every 4 hours, 15.5%, P <.001; dinoprostone gel, 33.0%, P =.022; intravenous oxytocin, 30.2%, P =.027; and spontaneous onset of labor, 23.3%, P <.001). Hyperstimulation occurred more often with dinoprostone gel (16.5%) than with other forms of induction or spontaneous labor. Hyperstimulation occurred significantly more often with vaginal misoprostol crushed tablet (7.9%) and vaginal misoprostol intact tablet (7.6%) than with crushed oral misoprostol (1.0%) (P =.016 and.018, respectively). There was a shorter time to tachysystole with increasing doses of vaginal misoprostol tablet (P =.01). CONCLUSION: The incidence of tachysystole and hyperstimulation, and time to tachysystole, varied depending on the route and form of misoprostol given.     

Comparison of induction of labor methods for unfavorable cervices in trial of labor after cesarean delivery

Objective: To compare induction of labor methods in patients attempting a trial of labor after cesarean (TOLAC) with an unfavorable cervix.

Methods: This is a retrospective cohort study from patients attempting TOLAC from 2009 to 2013. Patients with a simplified Bishop score of three or less where labor was initiated with either a Cook balloon or oxytocin were included. Our primary outcome was mode of delivery. Our secondary outcomes included duration of labor and multiple maternal and neonatal morbidities.

Results: Two-hundred and fourteen women met inclusion criteria: 150 received oxytocin and 64 had the Cook balloon placed. The vaginal birth after cesarean delivery rate was significantly higher in the oxytocin group at 70.7% versus 50.0% in the Cook balloon group (p?=?0.004). In the multivariable analysis, odds for cesarean delivery were two times higher with the Cook balloon than with oxytocin (Adjusted OR?=?2.09, 95% CI?=?1.05-4.18, p?=?0.036). The duration of labor was longer with the Cook balloon versus oxytocin (21.9 versus 16.3?hours, p?=?0.0002). There were no significant differences in maternal and neonatal health outcomes.

Conclusion: Oxytocin induction of labor was associated with a higher rate of vaginal delivery and a shorter duration of labor compared to the Cook balloon in women undergoing TOLAC with an unfavorable cervix.     

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.     

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 dinoprosone 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.