Influence of misoprostol or prostaglandin E(2) for induction of labor on the incidence of pathological CTG tracing: a randomized trial

OBJECTIVE: To compare the efficacy and safety of misoprostol (prostaglandin E(1) (PGE(1))) with dinoprostone (prostaglandin E(2) (PGE(2))) for third trimester cervical ripening and labor induction. STUDY DESIGN: Patients requiring induction of labor were randomly assigned to receive either 50 microg of intravaginal misoprostol every 4 h or 0.5 mg of intracervical dinoprostone gel every 6 h. Eligibility criteria included gestation = 36 weeks. Primary outcome was the time interval from induction to delivery; secondary outcomes were mode of delivery, perinatal outcome, and interpretation of cardiotocogram (CTG) records. RESULTS: Two hundred women were randomly enrolled to receive either misoprostol (n = 100) or dinoprostone (n = 100). Time induction-to-delivery at 12, 24 and 48 h and the need for oxytocin were reduced with misoprostol (P < 0.05). Pathological CTG tracing according to FIGO and Melchior scores were more frequent in the misoprostol-treated group (P < 0.001). CONCLUSION: Misoprostol shortened the induction-to-delivery interval, but is associated with a higher incidence of abnormal CTG than prostaglandin E(2).     

A comparison of intermittent vaginal administration of two different doses of misoprostol suppositories with continuous dinoprostone for cervical ripening and labor induction

Purpose : To compare the efficacy of a vaginal insert administering continuous dinoprostone with vaginal suppositories containing two different doses of misoprostol for cervical ripening and induction of labor. Study design : In this prospective, randomized, double-blinded study, 118 patients with indications for induction of labor and an unfavorable Bishop score were randomly assigned to receive either continuous dinoprostone, misoprostol 35- &#119 g suppositories, or misoprostol 50- &#119 g suppositories. Results : No significant differences were noted among the three groups in the change of Bishop score, induction of active labor or the time from initial treatment to delivery. Active labor occurred in roughly two-thirds of the patients in an average of about 5.7-6.7 h regardless of treatment assignment. When the two misoprostol groups were combined, a shorter interval from insertion to vaginal delivery was observed in the nulliparous women receiving misoprostol than those receiving continuous dinoprostone (21.3 vs. 27.2 h, p = 0.019). Except for the significantly lower incidence of tachysystole observed in the combined misoprostol group (3.8% vs. 15.4%, p = 0.036), there were no other significant differences between the groups in mode of delivery or in adverse maternal, fetal, or neonatal effects. Conclusion : Misoprostol suppositories appeared to be as effective and safe as continuous dinoprostone in inducing cervical ripening in this sample.     

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

PURPOSE: To compare the efficacy of a vaginal insert administering continuous dinoprostone with vaginal suppositories containing two different doses of misoprostol for cervical ripening and induction of labor. STUDY DESIGN: In this prospective, randomized, double-blinded study, 118 patients with indications for induction of labor and an unfavorable Bishop score were randomly assigned to receive either continuous dinoprostone, misoprostol 35-microg suppositories, or misoprostol 50-microg suppositories. RESULTS: No significant differences were noted among the three groups in the change of Bishop score, induction of active labor or the time from initial treatment to delivery. Active labor occurred in roughly two-thirds of the patients in an average of about 5.7-6.7 h regardless of treatment assignment. When the two misoprostol groups were combined, a shorter interval from insertion to vaginal delivery was observed in the nulliparous women receiving misoprostol than those receiving continuous dinoprostone (21.3 vs. 27.2 h, p = 0.019). Except for the significantly lower incidence of tachysystole observed in the combined misoprostol group (3.8% vs. 15.4%, p = 0.036), there were no other significant differences between the groups in mode of delivery or in adverse maternal, fetal, or neonatal effects. CONCLUSION: Misoprostol suppositories appeared to be as effective and safe as continuous dinoprostone in inducing cervical ripening in this sample.     

Cervical ripening: A randomized comparison between intravaginal misoprostol and an intracervical balloon catheter combined with intravaginal dinoprostone

OBJECTIVES: Our purpose was to compare the efficacy of intravaginal misoprostol and intracervical Foley catheter/intravaginal dinoprostone for cervical ripening. STUDY DESIGN: Patients admitted for induction of labor were randomized to receive intravaginal misoprostol 25 μg every 4 hours or intracervical Foley catheter/intravaginal dinoprostone 4 mg every 4 hours. Patients not entering active labor and having ruptured membranes or arrest of dilatation received intravenous oxytocin. RESULTS: Sixty-five patients received Foley catheter/dinoprostone gel and 62 patients received misoprostol. The mean time until cervical ripening was less in the catheter/gel group (7.5 ± 3.4 vs 12.0 ± 5.9 hours, p < 0.01). The mean time until vaginal delivery was less in the catheter/gel group (17.4 ± 6.9 vs 21.2 ± 7.5 hours, p = 0.004). Among vaginal deliveries, more patients in the catheter/gel group delivered within 24 hours (90% vs 69%, p = 0.013). CONCLUSIONS: Intracervical Foley catheter/intravaginal dinoprostone was associated with more rapid cervical ripening, shorter induction to vaginal delivery interval, and greater number of vaginal deliveries within 24 hours. (Am J Obstet Gynecol 1998;178:1333-40.)     

Randomized comparison between intravaginal misoprostol and dinoprostone for cervical ripening and induction of labor.

OBJECTIVE: We sought to evaluate the efficacy and safety of intravaginal misoprostol and dinoprostone for labor induction. STUDY DESIGN: One hundred eighty-nine women with singleton term pregnancies and unfavorable cervices were randomly assigned to receive intravaginal misoprostol or dinoprostone. The outcome variables were change in Bishop score, time from application to active phase of labor and delivery, fetal and maternal morbidity, and the incidence of cesarean deliveries. RESULTS: The interval from application of the initial dose to the beginning of the active phase of labor was 9.8 +/- 5.8 and 14.2 +/- 10.2 hours (P <.01), and the interval from initial dose to delivery was 15.3 +/- 9.8 and 19.1 +/- 13.2 hours (P =.027) for the misoprostol and dinoprostone groups, respectively. There were no significant differences in Bishop score change, cesarean delivery rate, and the incidence of tachysystole, hypersystole, and hyperstimulation. No maternal and neonatal adverse effects were noted. CONCLUSION: Intravaginal misoprostol is more effective than intravaginal dinoprostone for labor induction in low-risk patients at term with unfavorable cervices.     

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.     

Induction of labor with intravaginal misoprostol versus intracervical dinoprostone

Sixty five pregnant women who had the indication for labor induction were randomized in a clinical trial to receive 100 μg. intravaginal misoprostol or intracervical gel of 0.5 mg dinoprostone. The mean time from induction to delivery for the misoprostol group was 7.6±1.9 versus 8.2±5.9 (hours±SD) for the dinoprostone group. There were no significant differences between groups in gestational age, induced labor rates, type of delivery, fetal outcome and maternal complications. We found that intravaginal misoprostol tablet is as effective as intracervical dinoprostone for inducing second and third trimester labor. Received: 15 July 1996 / Accepted: 10 September 1996     

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.     

Randomized trial in multiparous patients: investigating a single vs. two-dose regimen of intravaginal misoprostol for induction of labor

BACKGROUND: Multiparous patients have a higher risk of hyperstimulation and uterine rupture than nulliparous patients. The minimum possible dose of uterotonic drug should be used in induction of labor for multiparous patients to avoid excessive uterine activity, which could increase both maternal and fetal risks. METHODS: One hundred and four women were randomized to either a single dose of 50 micro g of intravaginal misoprostol in 24 h, or two consecutive doses of intravaginal 50 micro g misoprostol 6 h apart. RESULTS: The mean induction to delivery interval (789 min [95% CI: 637-941] vs. 576 min [95% CI: 484-667], p = 0.018) and delivery rate within 12 h (63% vs. 83%, p = 0.035) were higher in the two-dose group. The oxytocin augmentation rate (14% vs. 2%, p = 0.03) was higher in the single-dose group. There was a higher rate of clinician input related to suspicious cardiotocographic readings in the single-dose arm (p = 0.04). There was no statistical difference (p > 0.05) between the one- and two-dose regimens with respect to the rates of tachysystole (21% vs. 15%), hyperstimulation (3.9% vs. 0%), and meconium staining at delivery (9.8% vs. 13.2%). CONCLUSIONS: The two-dose regimen was most efficient, but both regimens were well tolerated by the fetuses.     

Randomized trial between two active labor management protocols in the presence of an unfavorable cervix

OBJECTIVE: The purpose of this study was to compare the efficacy of two protocols for active management of labor at term in the presence of an unfavorable cervix. STUDY DESIGN: Pregnancies that underwent labor induction at > or =37 weeks of gestation with an unfavorable cervix (Bishop score, < or =6) were randomly assigned to receive vaginally either a single dose of sustained-release dinoprostone (Cervidil) with concurrent low-dose oxytocin or multidosing of misoprostol (25 microg every 4 hours) followed by high-dose oxytocin. The primary outcome was the time interval from induction to vaginal delivery. Other parameters included excess uterine activity and cesarean delivery rates. RESULTS: A total of 151 patients (dinoprostone, 74 patients; misoprostol, 77 patients) were enrolled. The mean time from the initiation of induction to vaginal delivery was the same in the dinoprostone and misoprostol groups (15.7 hours; 95% CI, 13.7-17.7 hours vs 16.0 hours; 95% CI, 14.1-17.8 hours; P=.34), regardless of parity. The dinoprostone and misoprostol groups did not differ statistically in the percent of patients who were delivered vaginally by 12 hours (36.2% vs 29.7%), 18 hours (63.8% vs 56.3%), and 24 hours (81.0% vs 81.3%). Excess uterine activity was not more common in either group, and hyperstimulation syndrome was absent in all cases. Primary cesarean delivery rates were similar (dinoprostone, 21.6%; misoprostol, 16.9%; relative risk, 1.3; 95% CI, 0.7-2.5), with a failed induction that occurred in one case in each group. CONCLUSION: Sustained-release dinoprostone with concurrent low-dose oxytocin and intermittent misoprostol with delayed high-dose oxytocin are effective alternatives for active management of labor with an unfavorable cervix.     

Is misoprostol safe for labor induction in twin gestations?

OBJECTIVE: To compare the safety and efficacy of intravaginal misoprostol to oxytocin for the induction of labor in twin gestations. METHODS: All twin gestations that underwent induction of labor with misoprostol or oxytocin during a 4-year period were identified from the Mount Sinai obstetrical database. Only twins > or = 34 weeks with a vertex presenting twin A were included. Labor and delivery characteristics, maternal complications and neonatal outcomes were compared between the two groups. RESULTS: Of 134 patients with twins, 57 initially received misoprostol and 77 received oxytocin. These groups had similar demographics, but women who received misoprostol had less cervical dilation (0.8 vs. 2.2 cm, p < 0.0001) and were less likely to be multiparous (19% vs. 44%, p = 0.003). There was a shorter length of induction to delivery (7.8 hours vs. 15.1 hours, p = 0.001) and a trend toward a lower cesarean section rate (16.9% vs. 31.6%, p = 0.06) in the oxytocin-only group. There were no cases of uterine rupture or maternal mortality in this series. There were no significant differences in neonatal outcomes between the two groups, but the sample size was underpowered to detect significant differences between the groups. CONCLUSIONS: Misoprostol and oxytocin both appear to be safe and efficacious for use in inductions of labor in twins in this limited retrospective investigation. The safety of these agents with regard to neonatal outcomes should be confirmed by larger studies.     

Misoprostol versus dinoprostone for cervical priming prior to induction of labour in term pregnancy: a randomised controlled trial

A prospective randomised controlled trial was performed to compare the efficacy and safety of intravaginal misoprostol to that of intravaginal dinoprostone when used for cervical priming prior to the induction of labour; 126 women were recruited to the study and randomised to receive either intravaginal dinoprostone (n = 63) or misoprostol (n = 63) for cervical priming prior to induction of labour. The mean time from insertion of the priming agent to vaginal delivery was significantly shorter in the misoprostol group (925.8 versus 1577.6 minutes), the mean duration of the active length of labour was significantly shorter in the misoprostol group (353.7 versus 496.8 minutes) and more women in the misoprostol group delivered in less than 12 hours (92% versus 76.5%). Women in the misoprostol group were less likely to require a repeated dose of prostaglandin for cervical priming and less likely to require oxytocin for augmentation of labour. There was no difference in the number of women who were delivered vaginally or by Ceasarean section between the two groups. More women developed hyperstimulation during labour in the misoprostol group; however there was no difference between the groups in neonatal outcome in respect to low cord pH or Apgar score at delivery or admission to the neonatal special care nursery.     

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.     

Oral misoprostol versus intracervical dinoprostone for induction of labor.

OBJECTIVES: To compare oral misoprostol with dinoprostone for induction of labor and their effects on the fetal heart rate patterns. METHODS: In a randomized controlled trial, 200 patients received either misoprostol 50 mug orally for every 4 h, or dinoprostone 0.5 mg intracervically for every 6 h. Cardiotocographic recordings, in 10-min windows 30, 60, and 80 min after prostaglandin administration during induction and continuously during labor, were compared between the two groups. Primary outcome for effectiveness and safety was assessed in terms of the number of vaginal deliveries within 24 h and fetal heart rate abnormalities during induction and labor respectively. RESULTS: Data from 96 patients in the misoprostol group and 95 in the dinoprostone group were analyzed. There were no significant differences in respect of the number of vaginal deliveries within 24 h (RR 1.12; 95% CI 0.88-1.42). The frequency of suspicious and pathological fetal heart rate patterns did not differ significantly but significantly more cardiotocographs in the dinoprostone group had non-reassuring baseline variability 60 min after dose administration (RR 0.33; 95% CI 0.14-0.77). Maternal and neonatal outcomes did not differ significantly. CONCLUSION: Oral misoprostol is as effective as intracervical dinoprostone for induction of labor with no difference in the frequency of fetal heart rate abnormalities.     

A comparison of misoprostol and prostaglandin E2 gel for preinduction cervical ripening and labor induction

Objective: Our purpose was to compare the safety ad efficacy of intravaginal misoprostal versus intracervical prostaglandin E₂ (dinoprostone) gel for preinduction cervical ripening and induction of labor.Study design: One hundred thirty-five patients with indications for induction of labor and unfavorable cercices were randomly assigned to receive either intravaginal misoprostol or intracervical dinoprostate. Fifty microgram tablets of misoprostol were placed in the posterior vaginal fornix every 3 hours for a maximum of six doses. Prostaglandin E₂ in gel form, 0.5 mg, was placed into the endocervix every 6 hours for a maximum of three doses. Medication was not given after either spontaneous rupture of membranes or beginning of active labor.Results: Among 135 patients enrolled, 68 received misprostol and 67 dinoprostone. The average interval from start of induction to vaginal delivery was shorter in the misoprostol group (903.3 ± 482.1 minutes) than in the dinoprostone group (1410.9 ± 869.1 minutes) (p < 0.001). Oxytocin augmentation of labor occurred more often in the dinoprostone group (65.7%) than in the misoprostal group (33.8%) p < 0.001). There were no significant differences between routes of delivery. Ten of the misoprostol-treated patients (14.7%) and 13 of the dinoprostone-treated patients (19.4%) had cesarean deliveries. There was a higher prevalence of tachysystole (six or more uterine contractions in a 10-minute window for two consecutive 10-minute periods) in the misoprostol group (36.7%) than in the dinoprostone group (11.9%) (p < 0.001). However, there were no significant differences in frequency of uterine hyperstimulation or hypertonus. There was a higher prevalence of meconium passage in the misoprostol group (27.9%) than in the dinoprostone group (10.5%) (p < 0.05). Thee was no significant difference in frequency of abnormal fetal heart rate tracings, 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 an effective agent for cervical ripening and induction of labor; however when given at this dosage, it is associated with a higher prevalence of tachysystole and meconium passage than is dinoprostone. Further studies to compare the safety of misoprostol to that of dinoprostone and to delineate an optimal dosing regimen for misoprostol are needed.     

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.     

Randomized controlled trial of 50 and 100 mcg of misoprostol for induction of labor at term

To compare the safety and efficacy of two different regimens of misoprostol for labor induction at term, we conducted a randomized controlled trial on women presenting for induction of labor at >37 weeks’ gestation. Eligible women were randomized to receive intra-vaginal misoprostol 50 μg every 4 h or 100 μg every 6 h until any of the following: 1) adequate contraction pattern (3 contractions/10 min); 2) dilatation >3 cm; 3) artificial rupture of membranes; or 4) signs of uterine hyperstimulation. Use of oxytocin during labor was at the discretion of the managing clinician. The main outcome variable considered for analysis was cesarean section rate. Secondary outcome measures were induction to delivery interval and neonatal outcome (Apgar scores, meconium staining, and umbilical artery pH). A total of 58 women were randomized to receive either misoprostol 100 μg (n=26) or 50 μg (n=32). The 100 and 50 μg groups had similar mean Bishop’s scores at induction (4.0±2.3 vs 4.1±2.2, p=0.87), rates of nulliparity, use of epidural anesthesia, and oxytocin augmentation. The number of doses of misoprostol used was similar in the two groups (1.4±0.6 vs 1.8±1.2). The mean±standard deviation time to delivery (hours) (11.9± 7.3 vs 14.3±9.6 h, p=0.30) and cesarean section rate (35% vs 19%, p=0.30, relative risk: 1.8, 95% confidence interval 0.7–5.4) were not different in the 100 vs 50 μg group. Power analysis demonstrated that 132 women would be required in each group to achieve statistical significance in the primary outcome measure (α=0.05, β=0.80). Similarly, rates of 5-minute Apgar scores <7 (4% vs 3%, p=1.0), and of meconium passage (17% vs 25%, p=0.73) were not significantly different between the two groups. Received: 20 January 2001 / Accepted: 7 March 2001     

Is high-dose misoprostol able to lower the incidence of cesarean section? A randomized controlled trial

OBJECTIVE: To determine whether high-dose (100 microg) misoprostol was able to increase the rate of successful labor induction and lower the incidence of Cesarean section without adverse fetal effects. METHODS: A total of 360 women were randomized to receive either oxytocin (n = 192) by intravenous infusion, or misoprostol (n = 168) 100 microg intravaginally every 4 h. The Cesarean section rate was the primary end-point. Incidences of uterine and fetal heart rate abnormalities during labor and adverse neonatal outcomes were assessed as secondary end-points. RESULTS: Compared with those women receiving oxytocin, patients given misoprostol had a significantly shortened labor (10.7+/-6.0 vs. 15.4+/-10.4 h, p < 0.001). The Cesarean section rate did not differ between patients receiving misoprostol or oxytocin (36 (21.4%) vs. 38 (19.8%), p = 0.79) despite a sample size adequate to detect a 13 percentage point difference in this outcome. Patients receiving misoprostol had a higher incidence of the hyperstimulation syndrome (27 (16.1%) vs. 9 (4.7%), p < 0.001), and of fetal intolerance of labor as an indication for Cesarean delivery (23 (63.9%) vs. 15 (39.5%), p = 0.06), and had a greater number of umbilical artery cord blood pH findings of< 7.20 (20 (43.5%) vs. 6 (17.1%), p = 0.02). These worrisome trends on interim analysis resulted in our prematurely terminating the study. CONCLUSION: High-dose intravaginal misoprostol did not reduce the Cesarean section rate and was associated with a greater hazard of fetal intolerance of labor.     

A comparison between intravaginal and oral misoprostol for labor induction: a randomized controlled trial

AIM: To compare the effectiveness and safety between intravaginal and oral misoprostol for labor induction. METHODS: One hundred and six pregnant women at term with unfavorable cervix (Bishop score < or = 4) and no contraindication to prostaglandin therapy were randomized to receive either intravaginal misoprostol 50 microg every 4 h or oral misoprostol 50 microg every 4 h for prospective randomized controlled trial study. Treatment interval from induction to vaginal delivery, maternal and neonatal complications were the main outcome measures. RESULTS: There were no statistical differences of baseline characteristics and Bishop score prior to intervention between both groups. Time interval from induction to vaginal delivery in the oral group was slightly, but significantly, longer than that of the intravaginal group (886.1 +/- 443.5 min vs 637.0 +/- 373.3 min, respectively.) Additionally, the number of doses required was significantly higher in the oral group. Nonetheless, there was no significant difference between both groups with regard to failure of induction and maternal-neonatal complications. CONCLUSION: The effectiveness in terms of failed induction and safety were comparable between intravaginal and oral misoprostol, but intravaginal route was better with respect to treatment interval and number of required doses. Both routes of administration can alternatively be used for labor induction.     

Misoprostol: An effective agent for cervical ripening and labor induction

Objective: Our purpose was to compare the safety and efficacy of intravaginal misoprostol versus intracervical prostaglandin E₂ gel (dinoprostone) for preinduction cervical ripening and induction of labor.Study design: Two hundred seventy-six patients with indications for induction of labor and unfavorable cervices were randomly assigned to receive either intravaginal misoprostol or intracervical dinoprostone. Twenty-five micrograms of misoprostol were placed in the posterior vaginal fornix every 3 hours, with a potential maximum of eight doses. Prostaglandin E₂ in gel form, 0.5 mg, was placed in the endocervix every 6 hours, with a maximum of three doses. Further medication was withheld with the occurence of spontaneous rupture of membranes, entry into active phase of labor, or a “prolonged contraction response.”Results: Among those evaluated, 138 received misoprostol and 137 received dinoprostone. The average interval from start of induction to vaginal delivery was shorter in the misprostal group (1323.0 ± 844.4 minutes) than in the dinoprostone group (1532.4 ± 706.5 minutes) (p < 0.05). Need for oxytocin augmentation of labor occurred more commonly in the dinoprostone group (72.6%) than in the misprostol group (45.7%) (p < 0.0001). There were no significant differences in the routes of delivery. Twenty-eight of the misoprostol-treated patients (20.3%) and thirty-eight of the dinoprostone-treated patients (27.7%) required abdominal delivery. Complications such as uterine lachysystole and thick meconium passage occurred with similar frequency in the two treatment groups.Conclusions: Intravaginal administration of misoprostol appears to be as effective as intracervical dinoprostone for cervical ripening and labor induction. Complications associated with prostaglandin administration were not statistically different between the two treatment groups. The cost of misoprostol ($0.36/100μg) is much less than that of dinoprostone ($75/0.5mg).