A randomized trial comparing vaginal misoprostol versus Foley catheter with concurrent oxytocin for labor induction in nulliparous women

The objective of this study was to compare the efficacy and safety of intracervical Foley catheter with concurrent use of oxytocin versus vaginal misoprostol for labor induction in nulliparous women. Nulliparous women with Bishop score <6 who presented for labor induction were randomized to either 25 microg vaginal misoprostol every 4 hours followed by oxytocin, if indicated, or intracervical Foley catheter with simultaneous use of oxytocin. Among the 162 patients enrolled, 79 (49%) received misoprostol and 83 (51%) received Foley/oxytocin. We were unable to demonstrate a statistically significant difference between the misoprostol group and Foley/oxytocin group in the incidence of cesarean delivery (35% versus 29%; p = 0.37). The induction-to-delivery time was significantly shorter in the Foley/oxytocin group (18 versus 24 hours; p < 0.01). No differences in intrapartum complications, neonatal outcomes, or maternal morbidity were found. When compared with vaginal misoprostol, intracervical Foley catheter combined with oxytocin has a similar efficacy and safety profile for labor induction in nulliparous women. Foley/oxytocin results in a shorter induction-to-vaginal delivery time compared with misoprostol.     

Vaginal Misoprostol vs. Concentrated Oxytocin Plus Low-Dose Prostaglandin E2 for Second Trimester Pregnancy Termination

Objective: To examine the efficacy of vaginal misoprostol for mid-trimester pregnancy termination.

Results: Interim analysis of the first 30 (15-misoprostol, 15-concentrated oxytocin) women demonstrated that the 2 groups were similar with regard to indication for delivery, gestational age, and demographic characteristics. Misoprostol was associated with a lower success rate (67 vs. 87%, P =. 2), a longer induction-delivery interval (22 h vs. 18 h, P =. 09), a higher rate of retained placenta requiring curettage (27 vs. 13%, P =. 65), and a higher live birth rate (50 vs. 0%, P =. 006).

Conclusions: Compared to a regimen of concentrated oxytocin plus low-dose prostaglandin E₂, misoprostol administered as vaginal tablets in a dose of 200 μg q 12 h is not satisfactory for mid-trimester pregnancy termination in an unselected population.

Methods: This randomized trial compared misoprostol, 200 μg per vaginum q 12 h to a protocol of concentrated oxytocin plus low-dose vaginal prostaglandin E₂ suppositories (10 mg q 6 h). Success was defined as an induction-to-delivery interval ≤24 h.     

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.     

A randomized controlled trial comparing two protocols for the use of misoprostol in midtrimester pregnancy termination

OBJECTIVE: Our purpose was to compare the efficacy of oral misoprostol with that of vaginal misoprostol for midtrimester termination of pregnancy. STUDY DESIGN: Women seen for midtrimester pregnancy termination were randomly assigned to receive either misoprostol orally in a dose of 200 microg every hour for 3 hours followed by 400 microg every 4 hours or vaginally in a dose of 400 microg every 4 hours. The protocol was followed for 24 hours, after which time further management was at the discretion of the attending physician. The primary outcome measure was the induction-to-delivery interval. Sample size was calculated a priori. Statistical analysis was performed with the t test for continuous variables and the chi(2) test for categorical variables. P <.05 was considered significant. RESULTS: One hundred fourteen women were randomized, with 49 receiving vaginal misoprostol and 65 receiving oral misoprostol. The two groups were comparable with respect to maternal age, parity, indication for pregnancy termination, gestational age, and maternal weight. The mean induction-to-delivery interval was significantly shorter for the vaginal group (19.6 +/- 17.5 hours vs 34.5 +/- 28.2 hours, P <.01). Length of stay was also shorter in the vaginal group (32.3 +/- 17.3 hours vs 50.9 +/- 27.9 hours, P <.01). Significantly more patients in the vaginal group were delivered within 24 hours (85.1% vs 39.5%, P <.01), and more patients in the oral group required changes in the method of induction when they were undelivered after 24 hours (38.2% vs 7%, P <.01). The only complication was an increase in febrile morbidity in the vaginal group (25% vs 6.7%, P =.046). This did not result in an increased use of antibiotics, and all the fevers resolved post partum without further complications. CONCLUSIONS: Vaginal administration of misoprostol resulted in a shorter induction-to-delivery interval. The shorter length of stay should result in improved patient care.     

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 misoprostol for premature rupture of membranes at term

OBJECTIVE: The study was undertaken to compare the efficacy, safety, and maternal satisfaction of oral misoprostol and intravenous oxytocin for labor induction in women with premature rupture of membranes at term. STUDY DESIGN: One hundred five women were stratified by parity and randomly assigned to oral misoprostol 75 microg every 4 hours as needed to establish labor or to intravenous oxytocin. RESULTS: The induction to vaginal delivery time with oral misoprostol was 737 (+/-426) minutes compared with 573 (+/-318) minutes with oxytocin (P=.04). The incidence of hyperstimulation was lower in the misoprostol group (6.0% vs 27.1%, P=.005). Women were more likely to be very satisfied with their care in the misoprostol group (86.0% vs 63.4%, P=.02). CONCLUSION: In women at term with premature rupture of membranes, oral misoprostol resulted in a longer induction to vaginal delivery interval but increased maternal satisfaction and less hyperstimulation compared with intravenous oxytocin. Further research is needed to assess uncommon neonatal and maternal outcomes.     

A randomized trial of oral and vaginal misoprostol to manage delivery in cases of fetal death

OBJECTIVE: To compare the effectiveness and side effects of oral and vaginal misoprostol for the termination of second and third trimester pregnancy with intrauterine fetal death. METHODS: Eighty pregnant women at 16-41 weeks' gestation with intrauterine fetal death were randomized in two groups to receive either 400 micro g of misoprostol orally every 4 hours (n = 40) or 200 micro g of misoprostol vaginally every 12 hours (n = 40) until the termination of pregnancy was completed. The adverse effects, progress, and outcomes of delivery were assessed. RESULTS: The groups were similar in age, weight, height, gestational age, parity, and modified Bishop scores before intervention. The mean induction-to-delivery time in the oral group (13.95 [standard deviation (SD) = 5.63] hours) was significantly shorter than the time in the vaginal group (18.87 [SD = 10.38] hours, P =.001). The number of deliveries within 24 hours after the initial drug administration in the oral group (92.5%) was significantly higher than the number in the vaginal group (67.5%, P <.001), and all delivered within 48 hours after the initial drug administration. However, the gastrointestinal side effects in the oral group was significantly higher than in the vaginal group (P =.005). CONCLUSION: Misoprostol (400 micro g given orally every 4 hours) was more effective than misoprostol (200 micro g given vaginally every 12 hours) for the termination of second and third trimester pregnancy with intrauterine fetal death, but with more gastrointestinal side effects.     

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).     

Oral misoprostol and intracervical dinoprostone for cervical ripening and labor induction: a randomized comparison

OBJECTIVE: To compare efficacy, safety, and tolerance of oral misoprostol with intracervical dinoprostone for cervical ripening and labor induction. METHODS: Two hundred women were randomized to receive single doses of oral misoprostol 200 microg or 0.5 mg of dinoprostone intracervically every 6 hours for a maximum four doses. RESULTS: The intervals from administration of the drug to active phase of labor (11.1 hours [7-24] versus 15.8 hours [7.5-29.62], P =. 01), to delivery (14.0 hours [8.42-27.61] versus 20.2 hours [16.7-32. 8], P =.01), and to rupture of membranes (10.0 hours [4.95-24.7] versus 15.6 hours [8.2-29.2], P =.003) were significantly shorter in the misoprostol group. All those variables were not distributed normally, so results are presented as median and interquartile range. The rates of women who needed oxytocin (68% versus 52%, P =.03) and cesarean for failed induction (9% versus 1%, P =.01) were higher in the dinoprostone group. CONCLUSION: A single dose of 200 microg oral misoprostol was more effective for cervical ripening and labor induction than 0.5 mg of dinoprostone intracervically every 6 hours, with a maximum of four doses.     

Safety and efficacy of misoprostol orally and vaginally: a randomized trial.

OBJECTIVE: To compare the safety and efficacy accompanying oral and vaginal misoprostol for cervical ripening. METHODS: One thousand four women with medical or obstetric indications for labor induction and unripe cervices were randomly assigned to receive oral or vaginal misoprostol. Initial doses of 200 microg oral and 50 microg vaginal misoprostol were increased to 300 microg oral and 100 microg vaginal after two doses, to a maximum of six doses. Misoprostol was given every 6 hours in both groups. We anticipated that 11% of women treated vaginally would require intervention during the ripening process. Intervention was defined as interruption of the ripening process before labor or Bishop score of 7 or a lack of response to six misoprostol doses. RESULTS: Five hundred three subjects were assigned to oral and 501 to vaginal administration. Oral misoprostol was associated with significantly higher frequencies of intervention (67 [13.3%] versus 42 [8.4%], P =.01), tachysystole (114 [23.6%] versus 85 [17.6%], P =.02), and hyperstimulation (90 [18.6%] versus 66 [13.7%], P =.04). There were no significant differences in cesarean rates (147 [29.2%] versus 120 [24.0%], P =.06), mean number of misoprostol doses used (1.5 versus 1.6, P =.18), or hours from drug administration to delivery (24.5 versus 25.4, P =.77) between the oral and vaginal groups, respectively. The numbers of deliveries between the groups within 24 hours was different (271 [56%] versus 290 [60%], P =.02), oral and vaginal, respectively. No adverse neonatal outcomes were noted. CONCLUSION: Oral misoprostol has similar efficacy as vaginal misoprostol but is associated with a higher frequency of excessive uterine contractility and intervention.     

Effect of oral misoprostol after second-trimester delivery: a randomized,blinded study

OBJECTIVE: To determine whether serial oral misoprostol shortens the third stage of labor in second-trimester pregnancy loss. METHODS: This was a randomized, double-blind, placebo-controlled study of women between 13 and 28 weeks' gestation admitted for spontaneous or induced pregnancy termination. Subjects were randomized to receive either misoprostol (200 microg) or placebo orally every hour for a maximum of three doses if the placenta had not delivered spontaneously within 10 minutes of the fetus. A dilute oxytocin infusion was given to women in both groups. The patients were managed expectantly until intervention was required or up to 6 hours when curettage was scheduled. RESULTS: One hundred eighteen women were randomized to misoprostol and 119 randomized to placebo. Fifty-eight (49%) and 55 (46%) of the misoprostol and placebo groups, respectively, did not receive their medication (P =.65, chi(2) test). There was no difference between the groups with regard to demographic features, method of pregnancy termination, or gestational age. Sixty-seven (57%) and 62 (52%) of the misoprostol and placebo groups, respectively, completed the third stage of labor within 2 hours (P =.47, chi(2) test). There was no statistically significant difference in the median time from fetus to placenta (60 versus 91 minutes in the misoprostol versus placebo group, P =.57, Mann-Whitney U test). There was no difference between the groups in the incidence of hemorrhage, need for transfusion, or curettage rate. CONCLUSION: The therapeutic use of oral misoprostol in the third stage of labor in second-trimester pregnancy loss does not reduce the time to complete spontaneous placental delivery.     

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.     

A comparison of oral misoprostol with vaginal misoprostol administration in second-trimester pregnancy termination for fetal abnormality

OBJECTIVE: To compare the clinical efficacy and side effects of oral misoprostol with vaginal misoprostol for second-trimester pregnancy termination. METHODS: A randomized clinical trial of medical pregnancy termination between 14 and 26 weeks' gestation was conducted. Three misoprostol regimens were compared: 400 microg vaginally at 6-hour intervals (group 1), 400 microg orally at 3-hour intervals (group 2), and a loading dose of 600 microg vaginally followed by 200 microg orally at 3-hour intervals (group 3). A sample size of 225 women was required for equivalence of the three regimens, with an interim safety analysis planned at 80 women. RESULTS: A significant difference between the groups was evident at the interim safety analysis and the study ceased. The subset of 84 women recruited before the study closure is described. There was a significant difference in the median time to achieve delivery among the three groups: group 1, 14.5 hours (95% confidence interval 12.0, 16.9), versus group 2, 25.5 hours (13.5, 23.8), versus group 3, 16.4 hours (interquartile range 14.2-37.3) (P =.042). Within 24 hours of commencement 85.7% of women in group 1, 44.8% in group 2, and 74.1% in group 3 delivered (P =.003). At 48 hours 0% in group 1, 20.7% in group 2, and 3.7% in group 3 were undelivered (P =.011). There was no difference in women's perceptions of the termination process. CONCLUSION: In second-trimester pregnancy termination, a vaginal misoprostol regimen of 400 microg every 6 hours was 1.9 times more likely to result in delivery within 24 hours from commencement than an oral regimen of 400 microg every 3 hours.     

Randomized comparison of 3 misoprostol protocols for abortion induction at 13-20 weeks of gestation

OBJECTIVE: To evaluate the induction-to-abortion time of 3 pharmacokinetic-based protocols at 13-20 weeks of gestation. STUDY DESIGN: A randomized trial was conducted on 153 patients. The oral group (n = 51) received 100 microg misoprostol orally every 2 hours, the vaginal group (n = 51) received 200 microg misoprostol vaginally every 4 hours, and the sublingual group (n = 51) received 100 microg misoprostol sublingually every 2 hours. RESULTS: The mean induction-to-delivery time was shorter in the sublingual group (mean, 651 +/- 507) as compared to the vaginal group (mean, 1,056 +/- 634, p = 0.01). The number of patients who delivered within 12 hours was significantly higher in the sublingual group (n = 39, 78%) as compared to the oral (n = 26, 52%) and vaginal (n = 20, 40%) groups (p < 0.001). The numbers of patients who delivered within 24 hours were comparable in the sublingual (n = 47, 94%) and oral (n = 46, 92%) groups but higher than in the vaginal group (n = 39, 78%; p = 0.02). The total misoprostol dose was 543 +/- 422 microg in the sublingual group, 878 +/- 533 microg in the vaginal group and 741 +/- 413 microg in the oral group (p < 0.001). CONCLUSION: A pharmacokinetic-based application of 100 microg of sublingual misoprostol every 4 hours is more effective for induction of second-trimester abortion as compared to 100 microg oral misoprostol every 2 hours and 200 microg vaginal misoprostol every 4 hours.     

A comparison of vaginally administered misoprostol with extra-amniotic saline solution infusion for cervical ripening and labor induction

OBJECTIVE: The purpose of this study was to compare intravaginal misoprostol with extra-amniotic saline solution infusion with concomitant oxytocin for cervical ripening and labor induction in viable pregnancies. STUDY DESIGN: Two hundred women with indications for labor induction and unfavorable cervices were assigned randomly to vaginal misoprostol or extra-amniotic saline solution infusion. Twenty-five micrograms of misoprostol was administered every 4 hours up to six doses, followed by intravenous oxytocin administration. Patients who had received extra-amniotic saline solution infusion also received intravenous oxytocin along with a maximum 12-hour saline solution infusion through Foley catheters that were placed above the internal cervical os. RESULTS: One hundred women were randomly assigned to misoprostol, and 100 women were assigned randomly to extra-amniotic saline solution infusion. The average interval from start of induction to vaginal delivery was longer in the misoprostol group (1323.3 +/- 700.3 minutes) than in the extra-amniotic saline solution infusion group (970.4 +/- 502.7 minutes; P =.006, log transformed data). Abnormal fetal heart rate tracings were found in 30% of the patients who received misoprostol and in 19% of the patients who received extra-amniotic saline solution infusion (relative risk, 1.6; 95% CI, 1.0-2.4; P =.05). There was more tachysystole in the misoprostol group (8%) than in the extra-amniotic saline solution infusion group (1%; P =.02). There were no differences in the routes of deliveries or neonatal outcomes between groups. CONCLUSION: Extra-amniotic saline solution infusion with oxytocin administration appears more effective and is associated with fewer maternal complications than misoprostol for cervical ripening and labor induction.     

Buccal versus intravaginal misoprostol administration for cervical ripening

OBJECTIVE: The purpose of this study was to compare the efficacy of misoprostol that is administered in the buccal pouch with the intravaginal route of administration. STUDY DESIGN: One hundred fifty-seven pregnant women with a singleton live gestation, Bishop score of <7, estimated fetal weight of <4500 g, and gestational age of >24 weeks were randomized to receive misoprostol that would be placed either in the buccal pouch or vagina every 6 hours. In the buccal group, after the first 2 doses of 200 microg, the dose was increased to 300 microg for the duration of the study (up to a total of 1600 microg). In the vaginal group, after the first 2 doses of 50 microg, the dose was increased to 100 microg for the duration of the study (up to a total of 500 microg). The primary outcome variable was the interval from the first dose to vaginal delivery. Power calculations indicated the need to enroll 71 patients in each arm of the study, which would allow for the detection of a 4-hour reduction in vaginal birth interval for buccal misoprostol. RESULTS: The hours from drug administration to vaginal delivery were similar between the buccal and vaginal groups (23.5 +/- 20.8 hours versus 21.3 +/- 13.4 hours), respectively. Thirty-five women (63%) versus 34 women (67%) delivered vaginally within 24 hours (P = not significant). The incidence of tachysystole was higher in the buccal group, 28 occurrences (38%) versus 15 occurrences (19%; P =.01). CONCLUSION: Buccal misoprostol is effective for cervical ripening but results in a higher incidence of tachysystole than does intravaginal administration.     

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.     

A comparison of orally administered misoprostol to intravenous oxytocin for labor induction in women with favorable cervical examinations

OBJECTIVE: The purpose of this study was to compare orally administered misoprostol with intravenous oxytocin infusion for labor induction in women with favorable cervical examinations (defined as a Bishop score of 6 or more). STUDY DESIGN: One hundred ninety-eight women with indications for labor induction and favorable cervical examinations were assigned randomly to receive oral misoprostol or oxytocin induction. Misoprostol, 100 mg, was administered every 4 hours up to 6 doses, or intravenous oxytocin was administered by standardized protocol. RESULTS: One hundred ten (55.6%) women received misoprostol; 88 (44.4%) received intravenous oxytocin. There was no statistically significant difference in the average interval from start of induction to vaginal delivery, being longer in the misoprostol group (789.4 +/- 510.2 minutes) than in the oxytocin group (654.0 +/- 338.2 minutes, P=.19, log-transformed data). Two women had tachysystole develop in each treatment group. More women in the misoprostol group experienced hyperstimulation (7/110, 6.4%) than in the oxytocin group (0/88, P=.02, Fisher exact test). Nine (8.1%) misoprostol-treated women and 8 (9.1%) oxytocin-treated women underwent cesarean deliveries (P=.82). There was a presumed uterine rupture in a misoprostol-treated multipara women. There were no statistically significant differences in neonatal outcomes between the groups. CONCLUSION: Oral misoprostol offers no benefit over intravenous oxytocin for labor induction in women with favorable cervical examinations. It is associated with a higher likelihood of uterine hyperstimulation and may increase the risk of uterine rupture.     

Is rectal misoprostol really effective in the treatment of third stage of labor? A randomized controlled trial

OBJECTIVE: The purpose of this study was to compare misoprostol 600 microg intrarectally with conventional oxytocics in the treatment of third stage of labor. STUDY DESIGN: In a controlled trial, 1606 women were randomly grouped to receive (1) oxytocin 10 IU plus rectal misoprostol, (2) rectal misoprostol, (3) oxytocin 10 IU, and (4) oxytocin 10 IU plus methylergometrine. The main outcome measures were the incidence of postpartum hemorrhage and a drop in hemoglobin concentration from before delivery to 24 hours after delivery. RESULTS: The incidence of postpartum hemorrhage was 9.8% in the group that received only rectal misoprostol therapy compared with 3.5% in the group that received oxytocin and methylergometrine therapy (P =.001). There were no significant differences among the 4 groups with regard to a drop in hemoglobin concentrations. Significantly more women needed additional oxytocin in the group that received only rectal misoprostol therapy, when compared with the group that received oxytocin and methylergometrine therapy (8.3% vs 2.2%; P <.001). The primary outcome measures were similar in the group that received only rectal misoprostol therapy and the group that received only oxytocin therapy. CONCLUSION: Rectal misoprostol is significantly less effective than oxytocin plus methylergometrine for the prevention of postpartum hemorrhage.     

A comparison of various routes and dosages of misoprostol for cervical ripening and the induction of labor

OBJECTIVE: The purpose of this study was to compare the efficacy of different routes of misoprostol administration for cervical ripening and the induction of labor. STUDY DESIGN: Three hundred thirty women at > or = 32 weeks gestation with a Bishop score < or = 6 and an indication for induction were randomized to 1 of 3 double-blinded groups: (1) 25 microg orally administered misoprostol plus 25 microg vaginally administered misoprostol, (2) orally administered placebo plus 25 microg vaginally administered misoprostol, or (3) 25 microg orally administered misoprostol plus vaginally administered placebo. Doses were repeated every 4 hours until onset of labor or a maximum of 12 doses were given. The primary outcome of the trial was vaginal delivery within 24 hours of the initiation of induction. Secondary outcomes were the time from induction to delivery, need for oxytocin augmentation, mode of delivery, frequency of side effects, and neonatal and maternal outcome. Analysis of variance, chi-square test, and logistic regression were used for analysis. RESULTS: There were no significant differences in maternal characteristics or indications for induction. The percentage of women who achieved vaginal delivery within 24 hours was highest in the vaginally administered misoprostol group: 67% compared with 53% in the oral-plus-vaginal group (P < .05) and 36% in the oral group (P < .05). The median time to vaginal delivery was shorter in the vaginal and oral-plus-vaginal misoprostol groups, 13.5 hours and 14.3 hours, respectively, when compared with 23.9 hours in the oral group (P < .05). The rate of cesarean delivery was lowest in the vaginal misoprostol group (17% compared with 30% in the oral-plus-vaginal group and 32% in the oral group; P < .05). Uterine tachysystole occurred least frequently in the oral misoprostol group (10% compared with 32% in the vaginal group and 34% in the oral-plus-vaginal group; P < .05). Uterine hyperstimulation also occurred least frequently in the oral misopro-stol group (4% compared with 15% in the vaginal group and 22% in the oral-plus-vaginal group; P < .05). CONCLUSION: At the doses studied, induction of labor with vaginally administered misoprostol is more efficacious than either oral-plus-vaginal or oral-only route of administration.