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     

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.     

Induction of labor in great grandmultipara with misoprostol

OBJECTIVE: To compare the efficacy and complications of intravaginal misoprostol application with oxytocin infusion for induction of labor in great grandmultiparous pregnancies with a Bishop score of <6. STUDY DESIGN: Sixty-four great grandmultiparous (delivering the tenth, or greater, infant) pregnant patients with a Bishop score of <6 were randomized in two groups with 32 patients receiving 50 microg intravaginal misoprostol four times with 4h intervals, and 32 patients receiving oxytocin infusion for induction of labor starting from 2 mIU/min, increasing it every 30 min with 2 mIU/min increments up to maximum of 40 mIU/min. The time from induction to delivery, the route of delivery, fetal outcome and maternal complications were recorded. Statistical analyses were performed using Mann-Whitney U-test, Chi-Square test and hypothesis test about differences for two proportions (t-test) to determine differences between the two groups. P < or = 0.05 was considered significant. RESULT: The mean time from induction to delivery was 9.91+/-4.30 and 10.88+/-4.72 h in the misoprostol and oxytocin administered group, respectively, with no significant difference between the groups. The rate of vaginal delivery was 84.4 and 87.5% in the misoprostol and oxytocin administered group, respectively, with no significant difference between the groups (P = 0.72). The rates of placental abruption and postpartum hemorrhage were similar in both groups and no case of uterine rupture occurred. The 1 and 5 min mean Apgar scores were 6.91+/-1.57-8.88+/-1.39 and 7.22+/-1.24-9.06+/-0.84 in the misoprostol and oxytocin administered group with no significant differences between the groups (P = 0.38 and 0.51). No case of asphyxia was present. The rate of admission to neonatal intensive care unit was higher in the misoprostol administered group, but the difference was not significant. CONCLUSION: Intravaginal misoprostol is an alternative method to oxytocin in induction of labor in great grandmultiparous pregnant women with low Bishop scores, as it is effective, cheap and easy to use. Safety about rare complications and neonatal morbidity needs clarifications with further studies.     

Induction of labor with misoprostol in pregnancies with advanced maternal age

OBJECTIVE: The objective was to compare the efficacy and complications of intravaginal misoprostol application with oxytocin infusion for induction of labor in advanced aged pregnancies with a Bishop score of < 6. STUDY DESIGN: A hundred advanced aged (> or = 35 years) pregnant patients with a Bishop score of < 6 were randomized into two groups. The first group (50 patients) received 50 microg intravaginal misoprostol four times with 4 h intervals and the second group received oxytocin infusion for induction of labor starting from 2 mIU/min and was increased every 30 min with 2 mIU/min increments up to a maximum of 40 mIU/min. The time from induction to delivery, the route of delivery, fetal outcome, and maternal complications were recorded. Statistical analyses were performed using the Mann-Whitney U, Chi-squared and t tests to determine differences between the two groups. A p value < or = 0.05 was considered significant. RESULTS: Misoprostol was superior for induction of labor in advanced aged pregnancies with Bishop score of < 6, as the mean time from induction to delivery was 9.61 +/- 4.12 h and 11.46 +/- 4.86 h in the misoprostol and oxytocin groups respectively, with a significant difference between the groups (p = 0.04). The rate of vaginal delivery was higher in the misoprostol group (84.0%) than in the oxytocin group (80.0%), but the difference did not reach significance (p = 0.60). The rates of placental abruption and postpartum hemorrhage were similar in both groups and no cases of uterine rupture occurred. The 1- and 5-min mean Apgar scores were 6.98 +/- 1.17 to 9.08 +/- 0.99 and 6.88 +/- 1.81 to 9.00 +/- 1.35 in the misoprostol and oxytocin groups respectively, with no significant differences between the groups (p = 0.74, p = 0.83). No cases of asphyxia were present. The rate of admission to the neonatal intensive care unit was similar in both groups. CONCLUSION: Intravaginal misoprostol seems to be an alternative method to oxytocin in the induction of labor in advanced aged pregnant women with low Bishop scores, as it is efficacious, cheap, and easy to use. But large studies are necessary to clarify safety with regard to the rare complications such as uterine rupture.     

Misoprostol 50 microg sublingually versus vaginally for labor induction at term: a randomized study

OBJECTIVE: To compare the efficacy of misoprostol 50 mug vaginally and 50 mug sublingually for labor induction at term. MATERIALS AND METHODS: One hundred and sixty women were randomized to receive misoprostol 50 microg vaginally (n = 80) or 50 microg sublingually misoprostol (n = 80). The doses were given every 4 h (maximum 6 doses). Primary outcome measure was number of cesarean deliveries. Induction to delivery time, delivery within 24 h, the number of misoprostol doses given; the need for oxytocin augmentation, tachysystole and uterine hyperstimulation rates and neonatal outcomes were secondary outcome measures. RESULTS: The mean induction to delivery time was 748 +/- 379 min in the vaginal group and 711 +/- 425 in the sublingual group (p = 0.56). The number of women delivering within 24 h was 73 (91.3%) in the vaginal group and 74 (92.5%) in the sublingual group (p = 0.78). The mean number of misoprostol doses required was significantly higher in the sublingual group (1.9 +/- 1.2) compared with the vaginal group (1.1 +/- 0.4; p < 0.001). More women in the sublingual group experienced tachysystole (n = 14, 17.5%) compared with the vaginal group (n = 3, 3.8%; p = 0.005). Seven cases (8.8%) in the vaginal group and 12 cases in the sublingual group (15%) required emergent cesarean delivery for fetal heart rate abnormalities (p = 0.22). Other neonatal outcomes including umbilical artery pH, Apgar scores and intensive care unit admission were similar in the two groups. CONCLUSION: Sublingual misoprostol is as efficacious as vaginal misoprostol for induction of labor. More frequent tachysystole is observed with misoprostol 50 microg sublingually, but neonatal outcomes are similar.     

Misoprostol for cervical ripening and labor induction in pregnancies with oligohydramnios

The efficacy and safety of misoprostol for cervical ripening and labor induction in patients with oligohydramnios was investigated. 57 pregnancies with oligohydramnios and 58 cases with a normal amniotic fluid volume (controls) were enrolled in this prospective trial. All patients received 50 microg of intravaginal misoprostol every 5 h. Primary outcomes were: cesarean section rate; induction to delivery time; oxytocin augmentation; uterine hyperstimulation; meconium passage; fetal heart rate (FHR) changes; fetal distress requiring delivery, and Apgar scores. There were no differences in the mean time to delivery, cesarean section rate, oxytocin augmentation or Apgar scores. The mean induction to delivery time in oligohydramnios and control groups were, 11 h 43 min and 11 h 18 min, respectively (p > 0.05). FHR changes were observed in 26.3% of oligohydramnios group and 32.7% of control group (p > 0.05). There was no statistically significant difference in the cesarean section rate and the uterine hyperstimulation between the 2 groups. These data suggest that misoprostol can be used as an effective agent for cervical ripening and labor induction in pregnancies with oligohydramnios without increasing the risk for perinatal outcome, compared to those with normal amniotic fluid volumes.     

The routine use of oxytocin after oral misoprostol for labour induction in women with an unfavourable cervix is not of benefit

BACKGROUND: Induction of labour with misoprostol is often augmented with oxytocin with the possible consequence of uterine hypercontractility. It is important to determine whether the use of oxytocin in this circumstance has benefit as well as risk. AIM: To compare two regimens for labour induction in women with an unfavourable cervix: oral misoprostol vs. oral misoprostol routinely followed by oxytocin. METHODS: A prospective randomised trial in which 200 women with an unfavourable cervix received either oral misoprostol 25 microg every 3 h (group 1, n = 100) or two such doses routinely followed by oxytocin (group 2, n = 100). Outcomes included change in Bishop score, induction delivery interval, oxytocin requirement, contraction abnormalities, mode of delivery and neonatal outcome. RESULT: The improvement in Bishop score with two misoprostol doses in all 200 women was highly significant (2.9 +/- 1.5 to 6.6 +/- 1.9, P < 0.0001). The induction delivery interval, Caesarean delivery rate, vaginal delivery rate within 24 h, contraction abnormalities and neonatal outcome were similar in both groups. Contraction abnormalities were remarkably low with either regimen (1%). Routine addition of oxytocin 3 h after the second misoprostol dose (group 2) resulted in the maximum oxytocin dose (64 mU/min) being given to more women (66% in group 2; 36% in group 1). CONCLUSION: There was no benefit of routine addition of oxytocin after two doses of misoprostol. Reduced oxytocin requirement was observed when it was added only if needed. Both regimens achieved 85-87% vaginal deliveries with low incidence of hypercontractility.     

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 oral and vaginal misoprostol for induction of labor

OBJECTIVE: The aim of the study is to compare the efficacy and safety of oral (100 microg) and vaginal (50 microg) misoprostol for labor induction. STUDY DESIGN: Ninety-nine patients with indications for labor induction randomly received 100 microg oral misoprostol every 4 h or 50 microg vaginal misoprostol every 4 h, using maximum six doses. Mean induction to delivery interval, mode of delivery, rates of tachysystole, hypertonus and hyperstimulation syndrome, oxytocin use, number of doses used, failed induction rate and neonatal outcomes were compared for the two groups. RESULTS: Mean dose of misoprostol used for oral and vaginal misoprostol groups were 2.17+/-1.35 and 1.91+/-0.94, respectively (p=0.65). There were two failed inductions in the oral (4%) and one failed induction (2.5%) in the vaginal group after a total of six doses of misoprostol (p=0.58). There was no significant difference for the mean induction to delivery interval, to the beginning of active phase interval, active phase duration, second stage duration and the number of women who received oxytocin for induction or augmentation between the two groups (p>0.05). There were also no significant differences for intrapartum complications and neonatal outcomes between the oral and vaginal misoprostol groups (p>0.05). CONCLUSION: Our findings indicate that, in a closely supervised hospital setting with adequate monitoring, 100 microg oral misoprostol has the potential to induce labor as safely and effectively as its 50 microg vaginal analogue. As oral use of the drug is easier for both the patient and the doctor, oral misoprostol will probably be more preferable than the vaginal route.     

Misoprostol vs. oxytocin for induction of labor at term.

Efficacy of misoprostol was studied for induction of labor at term. Seventy patients were randomized to Group A (n = 36, oral misoprostol 50 microg four hourly to maximum of 5 doses) and B (n = 34, continuous oxytocin infusion). Induction-delivery interval was shorter with misoprostol (7.7 +/- 2.8 h against 14.3 +/- 4.8 h with oxytocin) but the rates of vaginal delivery, cesarean, neonatal outcome variables were similar. Hence, misoprostol is an effective agent for induction of labor at term.     

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

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

Comparison of 25 and 50 microg vaginally administered misoprostol for preinduction of cervical ripening and labor induction.

Our purpose was to compare the efficacy of 25 microg and 50 microg intravaginally administered misoprostol tablets for cervical ripening and labor induction. Either 25-microg (n: 58) or 50-microg (n: 56) misoprostol tablets were randomly administered intravaginally to 114 subjects with an unripe cervix for labor induction. The physician was blinded to the medication. Intravaginal misoprostol was given every 4 h until the onset of labor. The mean Bishop score before misoprostol administration was 2.1 +/- 1.6 in the 25-microg group and 2.0 +/- 1.4 in the 50-microg group (p > 0.05). With the 25-microg dose the time until delivery was significantly longer (991.2 +/- 514.4 min vs. 703.12 +/- 432.6 min in the 50-microg group). The use of oxytocin augmentation was significantly higher in the 25-microg group (63.8%) than the 50-microg group (32.1%; p < 0.05). The proportions of patients with tachysystoles and hypersystoles were not significantly different between the two groups (19 and 6.9%, respectively, in the 25-microg group and 25 and 17.8%, respectively, in 50-microg group; p > 0.05). Overall, in the 25-microg group more women achieved vaginal delivery (79.3 vs. 60.7%; p < 0.05). The rate of cesarean sections due to non-reassuring fetal status was higher in the 50-microg misoprostol group (28.6 vs. 10.3%; p < 0.05). The number of neonates with a low 1-min Apgar score (<7) was significantly higher in the 50-microg misoprostol group (26.8 vs. 8.6%; p < 0.05), but 5-min Apgar scores and umbilical artery blood gas values at the time of delivery were not significantly different between the groups (p > 0.05). One patient in the 25-microg group suffered a ruptured uterus. Intravaginal administration of 25 microg of misoprostol is a clinically effective labor induction regimen and has the least adverse effects and complications.     

Randomized comparison of oral misoprostol and oxytocin for labor induction in term prelabor membrane rupture

OBJECTIVES: To compare labor induction intervals between oral misoprostol and intravenous oxytocin in women who present at term with premature rupture of membranes. METHODS: One hundred eight women were randomly assigned to misoprostol 50 microg orally every 4 hours as needed or intravenous oxytocin. The primary outcome measure was time from induction to vaginal delivery. Sample size was calculated using a two-tailed alpha of 0.05 and power of 80%. RESULTS: Baseline demographic data, including maternal age, gestation, parity, Bishop score, birth weight, and group B streptococcal status, were similar. The mean time +/-standard deviation to vaginal birth with oral misoprostol was 720+/-382 minutes compared with 501+/-389 minutes with oxytocin (P = .007). The durations of the first, second, and third stages of labor were similar. There were no differences in maternal secondary outcomes, including cesarean birth (eight and seven, respectively), infection, maternal satisfaction with labor, epidural use, perineal trauma, manual placental removal, or gastrointestinal side effects. Neonatal outcomes including cord pH, Apgar scores, infection, and admission to neonatal intensive care unit were not different. CONCLUSION: Although labor induction with oral misoprostol was effective, oxytocin resulted in a shorter induction-to-delivery interval. Active labor intervals and other maternal and neonatal outcomes were similar.     

Labor induction with vaginal misoprostol and extra-amniotic prostaglandin F2alpha gel.

OBJECTIVE: To compare the effectiveness of vaginally administered misoprostol with extra-amniotic prostaglandin F2alpha (PGF2alpha) gel for induction of labor. METHOD: A randomized controlled trial, with women allocated to receive either misoprostol 50 microg intra-vaginally or extra-amniotic PGF2alpha gel 5 mg, was conducted in Harare Maternity Hospital. A total of 152 women were admitted for induction of labor with a term singleton, pregnancy and cephalic presentation were recruited. The main outcome was duration of induction. RESULTS: There were no differences in the characteristics of women in the two groups at recruitment. In the misoprostol group there was a significantly reduced need for augmentation of labor with oxytocin (OR=0.36; 95% C.I. 0.17-0.73) and delivery by cesarean section for failure to progress (OR=0.11; 95% C.I. 0.00-0.88). The risk for duration of induction to vaginal delivery exceeding 12, 18 or 24 h was reduced by 18%, 38% and 68%, respectively, but only the risk for duration >24 h was significantly reduced (OR=0.32; 95%C.I. 0.11-0.91). The mean duration of induction was shorter in the misoprostol group, 15.2 vs. 23.6 h (P=0.02). There were no differences in fetal outcome. CONCLUSION: Misoprostol 50 microg was associated with less use of oxytocin in labor, a shorter induction to delivery interval and fewer cesarean sections for failure to progress when compared with extra-amniotic PGF2alpha gel.     

Induction of labor in toxemia with misoprostol

BACKGROUND: To compare the efficacy and complications of intravaginal misoprostol application with oxytocin infusion for induction of labor in toxemia of pregnancy with a modified Bishop score of < or =4. METHODS: A hundred preeclamptic women with a modified Bishop score of < or =4 were randomized into two groups of 50 patients one group receiving 50 microg intravaginal misoprostol 4 times at 4 hour intervals, the second group receiving oxytocin infusion for induction of labor starting from 1 mIU/per minute, increasing it every 30 minutes with 2 mIU/per minute increments up to maximum of 30 mIU/per minute. Modified Bishop scores 12 hours after induction, the time from induction to delivery, the route of delivery, fetal outcome and maternal complications were recorded. Statistical analyses were performed using Mann Whitney-U, Chi-Square and hypothesis tests about differences for two proportions (t test) to determine differences between the two groups. p< or =0.05 was considered significant. RESULTS: Misoprostol was significantly superior for induction of labor in toxemia of pregnancy with modified Bishop score of < or =4. After 12 hours median modified Bishop scores of misoprostol administered group and oxytocin administered group were 7 and 4 respectively. Misoprostol administered group 1 was significantly better than oxytocin administered group 2 (p=0.027). The rate of patients who were in labor after 12 hours were 94% and 80% in group 1 and 2 respectively and the difference showed significant difference (p<0.05). The median time from induction to delivery was 14 hours and 16 hours in the misoprostol and oxytocin administered group respectively with significant difference between the groups (p=0.003). The rate of vaginal delivery was significantly higher in the misoprostol administered group 1 (82%) when compared with the oxytocin administered group 2 (66%) (p<0.05). The 1 and 5 minutes median Apgar scores were 5-7 and 6-7.5 in group 1 and 2, respectively with no significant differences between the groups (p=0.96, p=0.64). The rate of admission to neonatal intensive care unit was similar in both groups. The complication rates were similar in all groups and no significant detrimental effects were noted. CONCLUSIONS: Intravaginal misoprostol is an efficacious, cheap and safe method of induction of labor in toxemia of pregnancy with modified Bishop score of < or =4.     

A randomized trial of misoprostol versus extra-amniotic sodium chloride infusion with oxytocin for induction of labor

OBJECTIVE: Our purpose was to compare the efficacy and safety of misoprostol and extra-amniotic sodium chloride infusion with oxytocin for induction of labor.Study Design: This randomized trial compared two methods of labor induction in women requiring cervical ripening. One hundred twenty-three women undergoing labor induction with a Bishop score < or =5 were randomly selected to receive either misoprostol, 50 microg intravaginally every 4 hours, or extra-amniotic sodium chloride infusion. The primary outcome variable was the time interval from induction to vaginal delivery. RESULTS: Sixty-one women received extra-amniotic sodium chloride infusion and 62 women received misoprostol. The mean time interval from the start of induction to vaginal delivery was 15.0 +/- 5.0 hours and 16.5 +/- 7.2 hours for the extra-amniotic infusion and misoprostol groups, respectively (P, not significant). The cesarean delivery rate was not significantly different between the 2 groups (32.8% for the extra-amniotic infusion group; 19.4% for the misoprostol group). Maternal and neonatal outcomes were similar between the 2 groups. CONCLUSIONS: Both methods of induction are equally efficacious and result in similar maternal and neonatal outcomes.     

Comparison of oral and vaginal misoprostol for induction of labor at term: a randomized controlled trial

OBJECTIVE: To compare the efficacy of oral with vaginal misoprostol for induction of labor at term. METHODS: One hundred and fifty-three pregnant women at term with indications for induction of labor and Bishop score < or = 6 were randomly assigned to receive misoprostol either 100 microg orally or 50 microg vaginally every 6 h for 48 h. Repeated doses were given until Bishop score > or = 8 was achieved or spontaneous rupture of membranes occurred. Those who were not in labor after 48 h had labor induced with amniotomy and oxytocin. The main outcome measure was induction to delivery time. RESULTS: The median induction to vaginal delivery time in the oral group (14.3 h) was not significantly different from that of the vaginal group (15.8 h). The median number of doses was also not significantly different in the oral group compared with the vaginal group. There was a significant higher incidence of uterine tachysystole in the vaginal group compared to the oral group (17.1% vs 5.3%, P = 0.032). There was no hyperstimulation in either group. There were no significant differences between the groups with respect to oxytocin augmentation, cesarean section rate, analgesic requirement, and neonatal outcomes. CONCLUSION: Oral administration of 100 microg misoprostol has similar efficacy to intravaginal administration of 50 microg misoprostol for labor induction with less frequent abnormal uterine contractility. 100 microg of misoprostol orally can be used as an alternative to the vaginal route for labor induction.     

Intracervical misoprostol and prostaglandin E2 for labor induction.

OBJECTIVES: To compare the safety and efficacy of misoprostol with PGE(2) for induction of labor by intracervical administration. METHODS: Eighty-six women with indications for labor induction at term were randomly assigned to two groups. Each woman received either 50 microg of misoprostol or 0.5 mg of prostaglandin E(2) intracervically. If labor was not initiated after 4 h, the same dose was repeated every 4 h to a maximum of 200 microg of misoprostol or 1.5 mg of PGE(2) until adequate labor was achieved. RESULTS: Forty-three women were allocated to the misoprostol group and 43 to the prostaglandin E(2) group. Misoprostol was more effective than PGE(2) in producing cervical changes (P<0.025). Delivery within 12 h after the first administration occurred more often in the misoprostol group than in the PGE(2) one (85% vs. 56%, P<0.05). Less patients in the misoprostol group required oxytocin augmentation than in the PGE(2) one (16.3% vs. 39.5%, P<0.05). Uterine tachysystole and hyperstimulation occurred more frequently in the misoprostol group (44.1%) than in the PGE(2) group (18.7%) (P<0.05). Nevertheless, no statistically significant differences were noted between the two groups including mode of delivery and neonatal or maternal adverse outcome. The interval from induction to vaginal delivery was significantly shorter in the misoprostol group (480+/-172 min vs. 657+/-436 min, P<0.01). CONCLUSIONS: Compared with prostaglandin E(2), intracervical misoprostol is more effective in cervical ripening and labor induction at term. The higher frequency of uterine hypercontractility associated with the use of misoprostol did not increase the risk of adverse intrapartum and neonatal outcomes.     

A comparison of 100 microg oral misoprostol every 3 hours and 6 hours for labor induction: a randomized controlled trial

OBJECTIVE: To compare the efficacy and safety of 100 microg oral misoprostol for induction of labor between the regimen of 3 hour and 6 hour interval administration. METHODS: Singleton pregnancies indicated for induction of labor between 34 and 42 weeks of gestation in the condition of unfavorable cervix (Bishop score < or = 4) and no contraindication for prostaglandins therapy were recruited into the study. All pregnant women were randomly assigned to receive 100 microg oral misoprostol every 3 hours or 6 hours until the cervix was favorable for amniotomy, spontaneous rupture of membranes or active labor occurred. RESULTS: The mean time interval from induction to vaginal delivery was significantly shorter in the 3 hour interval group, compared with the 6 hour interval group (13.82 +/- 6.98h and 17.66 +/- 7.48h, P = 0.0019). There was no significant difference between the groups with regard to mode of delivery, analgesic requirement, maternal complication and neonatal outcome. CONCLUSIONS: 100 microg oral misoprostol every 3 hours is more effective for labor induction than every 6 hours but there was no difference in mode of delivery, analgesic requirement, maternal complications and neonatal outcome. A dose of 100 microg misoprostol orally every 3 hours seems to be the optimum regimen and the new option for labor induction. However, further study should be performed.     

Outpatient misoprostol cervical ripening without subsequent induction of labor to prevent post-term pregnancy

BACKGROUND: Interventions that may help shorten the duration of pregnancy in an African setting where facilities for fetal monitoring in post-term pregnancy are limited, and induction is not without its hazards, are needed. AIM: To determine whether outpatient administration of intravaginal misoprostol safely decreases the interval to delivery in postdate pregnancies. DESIGN: Open randomized controlled trial. SETTING: Zonal district hospitals, Kwale, Southern Nigeria (August 2000 to October 2001). METHODS: Seventy-seven women were randomized at 40 weeks gestation to receive either 25 microg misoprostol intravaginally (38) or gentle cervical assessment only (39) on an outpatient basis. Subjects were then allowed to go into spontaneous labor unless an indication for induction developed. MAIN OUTCOME MEASURES: Interval to delivery, duration of labor, and incidence of side-effects. RESULTS: Misoprostol was associated with significant decrease in mean time to delivery (4.5 +/- 4.1 versus 7.4 +/- 5.2 days; P = 0.008), earlier gestational age at delivery (40.6 +/- 0.6 versus 41.4 +/- 0.05 weeks; P < 0.001) and shorter duration of active labor (6.1 +/- 4.0 versus 8.2 +/- 5.3 h; P = 0.028), without any significant increase in fetal distress, low Apgar score at delivery or other side-effects. CONCLUSION: Outpatient administration of low-dose misoprostol can safely shorten the length of gestation in postdate pregnancies.