Oral versus vaginal misoprostol for labor induction

OBJECTIVE: To compare the safety and effectiveness of vaginal with oral misoprostol for induction of labor. METHODS: A total of 107 women with clinical indication for induction were randomly assigned to receive oral or vaginal misoprostol. Doses of 100 microg of oral or 25 microg of vaginal misoprostol were given every 3-4 hours. If cervical ripening or active labor did not occur, repeated doses of oral (100-200 microg) or vaginal (25-50 microg) were given until labor was established. RESULTS: Fifty-nine women received oral misoprostol, and 48 received vaginal administration. Delivery time was similar for the vaginal and oral arms (1074 +/- 488 minutes versus 930 +/- 454 minutes, P =.11). Parity was significantly different (P =.04) for the vaginal and oral groups. The cesarean delivery rate was similar for the vaginal and oral arms (17% versus 15%, P =.72). The number of medication administrations was consistent between groups. Birth weight was not different for patients in the control and treatment groups (vaginal 3281 +/- 507 g versus oral 3359 +/- 541 g, P =.44). Chorioamnionitis and tachysystole were comparable for the oral and vaginal groups. There was no statistical difference in neonatal outcomes. Similar proportions of infants were admitted to the well baby nursery and intermediate care nursery. CONCLUSION: These findings indicate that, in a closely supervised hospital setting with adequate monitoring, oral misoprostol has the potential to induce labor as safely and effectively as its vaginal analogue.     

Titrated oral misoprostol solution versus vaginal misoprostol for labor induction

Objective

To determine the efficacy and safety of a titrated oral misoprostol solution compared with vaginal misoprostol tablets for labor induction.

Methods

A randomized, triple-blind, multicenter clinical trial was conducted between March 2010 and June 2011. Women with a single gestation (n = 200) were randomized to receive a titrated oral misoprostol solution (initial misoprostol dose 20 μg/hour; dose increased by 20 μg/hour every 6 hours up to 80 μg/hour for a maximum of 48 doses) or vaginal misoprostol tablets (25 μg of misoprostol every 6 hours for a maximum of 8 doses). Risk ratios (RR) and 95% confidence intervals (CIs) were calculated for maternal and perinatal outcomes.

Results

The frequencies of vaginal delivery not achieved within 12 hours (RR 0.87; 95% CI, 0.62–1.22) and within 24 hours (RR 1.11; 95% CI, 0.83–1.49) were similar in the 2 groups. No differences were found in terms of uterine hyperstimulation, unfavorable cervix at 12 and 24 hours, oxytocin augmentation, tachysystole, epidural analgesia, adverse effects, and perinatal outcome. Approximately 70% of the women preferred the oral solution.

Conclusion

A titrated oral misoprostol solution was as effective and safe for labor induction as vaginal misoprostol tablets.ClinicalTrial.gov: NCT00 992524     

Induction of labor with vaginal misoprostol plus oxytocin versus oxytocin alone

Objective

To compare the effect of an oxytocin infusion alone or preceded by an intravaginal application of misoprostol for labor induction in women with term pregnancies and a low Bishop score.

Methods

This study randomized 100 multiparous women with singleton pregnancies over 38 weeks and a Bishop score less than 6 to receive either a single 50-µg dose of misoprostol intravaginally 3 hours before initiation of the oxytocin infusion or only an oxytocin infusion. The time from induction to delivery, the route of delivery, and maternal and fetal outcomes were analyzed.

Results

The mean time from induction to delivery was 9.36 ± 1.97 hours in the misoprostol plus oxytocin group and 11.08 ± 3.23 in the oxytocin alone group (P = 0.002). The rates of vaginal delivery, 1- and 5-minute Agpar scores, placental abruption, and postpartum hemorrhage were similar between the 2 groups, as were the rates of admission to the neonatal intensive care unit. There were no cases of perinatal asphyxia.

Conclusion

A 50-µg intravaginal application of misoprostol before starting the oxytocin infusion is a more effective method of labor induction than an oxytocin infusion alone for our study population.     

Comparison of induction of labor with vaginal misoprostol plus oxytocin versus oxytocin alone in term primigravidae

Objective.?To compare the efficacy and complications of intravaginal misoprostol application before starting oxytocin infusion with oxytocin infusion alone for labor induction in term primigravidae pregnancies with low-Bishop score.

Methods.?This randomized study included 101 primigravidae women with singleton pregnancies >38 weeks and a Bishop score of <6. Group 1 (50 patients) received a 50-μg dose of intravaginal misoprostol, with an oxytocin infusion started 3?h later. Group 2 (51 patients) received only an oxytocin infusion for labor induction. The time from induction to delivery, the route of delivery and complications were analyzed.

Results.?The mean time from induction to delivery was 10.4?±?2.1?h in Group 1 and 13.7?±?3.4 in Group 2 (p?<?0.001). The rates of vaginal delivery, Apgar scores at 1st and 5th min, placental abruption, and postpartum hemorrhage were similar between the two groups.

Conclusion.?Intravaginal application of 50-μg misoprostol before starting oxytocin infusion is a more effective method of labor induction than oxytocin infusion alone in term primigravidae pregnant women with low-Bishop scores.     

Comparing vaginal misoprostol versus Foley catheter plus vaginal isosorbide mononitrate for labor induction

Objective(S): To compare the effectiveness and safety of intra-cervical Foley catheter combined with intra-vaginal isosorbide mononitrate (IMN) versus intra-vaginal misoprostol for cervical ripening and labor induction in pregnant women with unripe cervices.

Methods: Open-labeled randomized controlled trial in Cairo university hospital, Cairo, Egypt during 2012–2014. Three hundred and ninety-five pregnant women at term or post-term with an indication for labor induction and unripe cervix were included in the study. The subjects were randomly divided into two groups. Vaginal misoprostol was used in group 1 (n?=?197) and intra-cervical Foley catheter plus vaginal IMN in group 2 (n?=?198). Our main outcome measure was cesarean section rate.

Results: Among the 395 included patients there were significantly lower duration of induction of labor (p?<?0.001) in group 1with lower cesarean section rates [22.8% in group 1versus 33.3% in group 2; RR 0.7 (0.6–0.9), (p?=?0.020)]. Whereas the uterine hyperstimulation (p?<?0.001) was significantly higher in group 1. There were no significant differences between both groups as regard patients’ demographic characteristics.

Conclusions(s): Vaginal misoprostol is more effective but less safe than Foley catheter combined with vaginal IMN for induction of labor in term and post-term pregnancy.     

Mid-second-trimester labor induction: concentrated oxytocin compared with prostaglandin E2 vaginal suppositories

A concentrated oxytocin infusion and prostaglandin E2 (PGE2) vaginal suppositories were compared in a retrospective analysis for indicated abortion in the mid-second trimester (17-24 weeks' gestation). Eighty-one women underwent second-trimester pregnancy termination, 59 by PGE2 suppositories and 22 by concentrated oxytocin infusion. Success was achieved by PGE2 in 93% (55 of 59) and oxytocin in 91% (20 of 22). The mean duration of labor was 13.1 hours with PGE2 and 8.2 hours with oxytocin. The mean dose of PGE2 was 65.2 mg; of oxytocin, 200 units. Women who received PGE2 experienced nausea (46%), vomiting (37%), fever (64%), and diarrhea (20%) despite appropriate premedication. Few side effects occurred in the women who were treated with oxytocin. We conclude that concentrated oxytocin infusion seems to be a reasonable alternative to PGE2 vaginal suppositories for induction of labor in the mid-second trimester.     

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 administration for cervical ripening and labor induction

Intravaginal misoprostol has been shown to be an effective agent for cervical ripening and induction of labor. Vaginal application of misoprostol has been reported in over 9000 women worldwide and seems to have safety profile similar to that of endocervically and intravaginally administered dinoprostone. Concern arises with the use of higher doses of intravaginal misoprostol (50 mcg or more) and the association with uterine contractile abnormalities and for this reason, use of low-dose misoprostol regimen has been recommended by the American College of Obstetricians and Gynecologists. The recommendation is use of a 25-mcg dose of misoprostol inserted into the posterior vaginal fornix and repeated every 3 to 6 hours as needed. Misoprostol administration to women with prior cesarean births seems to increase the likelihood of uterine scar disruption and should not be used in these women. There are reports of uterine rupture in women with unscarred uteri treated with vaginally applied misoprostol. Therefore, all patients need to be monitored adequately after misoprostol administration. Although there is a growing body of data regarding the ambulatory use of intravaginal misoprostol for cervical ripening, its use for this purpose cannot be recommended outside of investigational protocols at this time because of concerns for maternal and neonatal safety.     

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 study on removable PGE2 vaginal insert versus PGE2 cervical gel for cervical priming and labor induction in low-Bishop-score pregnancy

BACKGROUND: Dinoprostone vaginal insert has been compared to Dinoprostone cervical gel in few studies, whose cases presented different Bishop scores and gestational ages at admission, and various treatment strategies in control arms. The present study compares the vaginal insert to the cervical gel in patients with low Bishop score at term. METHODS: Prospective multicenter randomized trial, with parity-based randomization. Admission criteria: single pregnancy with Bishop score of 0-4, gestational age of 37-41 weeks, intact membranes, no previous cesarean section, no bleeding or abnormal cardiotocography at admission. RESULTS: Vaginal prostaglandins were required as a second-line induction procedure in 25% of study patients versus 47.1% of controls (p < 0.03, chi2). Study patients experienced shorter induction-to-delivery time (920 +/- 428 versus 1,266 +/- 740 min, p <0,01), with a mean difference of 5 h and 46 min between the groups. Even though patients that received vaginal insert showed a trend of increased incidence of abnormal cardiotocography during labor (12% versus 6.3%) and hyperkinetic labor (11.8% versus 2.1%), the incidence of cesarean sections (21.4% versus 21.6%), cesareans for fetal distress (12.5% versus 11.8%), and umbilical artery pH <7.10 (4.9% versus 2.5%) was comparable between the two groups. CONCLUSIONS: Dinoprostone vaginal insert is more efficient than cervical gel in promoting cervical priming and labor induction in low-Bishop-score patients at term. The vaginal insert placement seems to be safe for the mother and the newborn, although larger studies are required to investigate uterine hyperstimulation incidence.     

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.     

Second dose of PGE2 vaginal insert versus Foley transcervical balloon for induction of labor after failure of cervical ripening with PGE2 vaginal insert

Purpose: To determine the success rate of induction of labor (IOL) using Foley transcervical balloon (FTB) versus prostaglandin E₂ (PGE₂) vaginal insert, following failure of cervical ripening with PGE₂ vaginal insert.

Materials and methods: A retrospective cohort study of all pregnant women admitted for IOL with either FTB or PGE₂ vaginal insert. Either second dose of PGE₂ vaginal insert or FTB was used as a second line treatment after failure (not giving birth in 24?h from insertion) of first PGE₂ vaginal insert.

Results: During the study period, 1162 women were admitted for IOL. Failure was reported in 322/852 (37.8%) in the FTB versus 162/310 (52.2%) in the PGE₂ group (p?2 as first line who did not deliver after 24?h, 14 had spontaneous rupture of membranes, 15 underwent stripping and 42 were in still in active labor. The remainder were allocated to either second trial of PGE₂ treatment (n?=?58) or FTB (n?=?33) with failure rate higher in the PGE₂ group, not statistically significant (p?=?0.23).

Conclusion: IOL with FTB was not superior to PGE₂ vaginal insert for IOL following failure of cervical ripening with PGE₂ vaginal insert.     

A randomized clinical trial comparing vaginal misoprostol versus cervical Foley plus oral misoprostol for cervical ripening and labor induction

We compared labor induced by vaginal misoprostol versus a supracervical Foley catheter and oral misoprostol. Singleton pregnancies at > or = 24 weeks' gestation were randomized to either an initial 25-microg dose of intravaginal misoprostol, followed by 50-microg intravaginal doses at 3- to 6-hour intervals, or a supracervical Foley balloon and 100 microg of oral misoprostol at 4- to 6-hour intervals. Primary outcome was time from induction to delivery. One hundred twenty-six women were randomized to vaginal misoprostol alone (group I) and 106 women to Foley and oral misoprostol (group II). The groups were similar in age, weight, gestational age, parity, indication for induction of labor, and oxytocin use. Cesarean delivery rates at 37% and cesarean indications were similar ( P = 0.25). The time from induction to delivery in group II (12.9 hours) was significantly shorter than that in group I (17.8 hours, P < 0.001). Uterine tachysystole occurred less often in the vaginal misoprostol group (21% versus 39%, P = 0.015). Compared with vaginal misoprostol, delivery within 24 hours was significantly more likely with a Foley balloon and oral misoprostol. The use of terbutaline and peripartum outcomes were similar in the two groups.     

Sublingual vs. vaginal misoprostol for induction of labor.

OBJECTIVE: To compare sublingual with vaginal misoprostol for the induction of labor. METHODS: This double-blind clinical trial randomized 150 women to receive every 6 h 25 mug of sublingual misoprostol and vaginal placebo or 25 mug of vaginal misoprostol and sublingual placebo. Maternal and neonatal outcomes were analyzed and risk ratios (RRs) with 95% confidence intervals (CIs) calculated. The significance level was 5%. RESULTS: Vaginal delivery rates were 57% in the sublingual group and 69% in the vaginal group (RR, 0.8; 95% CI, 0.6-1.1). There were 11 cases of fetal distress in the sublingual group and 4 cases in the vaginal group (RR, 2.7; 95% CI, 0.9-8.2). There were no significant differences in the number of doses needed, interval between first dose and delivery, incidence of contractility disturbances, or neonatal results. CONCLUSION: The administration of misoprostol 25 mug by the sublingual route was neither more effective nor safer than the same dose administered vaginally.     

Oral, vaginal and sublingual misoprostol for induction of labor.

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