Effect of Maternal Age and Body Mass Index on Induction of Labor Using Oral Misoprostol in Late-Term Pregnancies: A Retrospective Cross-Sectional Study.

INTRODUCTION: Several studies have shown that late- and post-term pregnancies are associated with an increased risk of perinatal morbidity and mortality. In this case, induction of labor is the recommended approach. For full-term pregnancies, various methods exist to prepare the cervix and/or commence labor. Prostaglandins serve the dual purpose of cervical ripening and labor induction, blurring the distinction between the two processes. The aim of this research was to evaluate the effect of maternal age and body mass index (BMI) on oral misoprostol induction of labor for late-term pregnancies. METHODS: This was a retrospective cross-sectional study (ClinicalTrial ID: NCT06184139), including only late-term pregnancies in healthy nulliparous women carrying a single cephalic fetus with normal birthweight who underwent induction of labor with oral misoprostol. We used the oral misoprostol regimen proposed by the World Health Organization (WHO) for induction of labor in term singleton pregnancies in women who have not had a previous cesarean delivery and a Bishop score <7. The regimen was oral misoprostol in aqueous solution at the low dose of 25 µg every 2 h until a Bishop score ≥7, labor, or for a maximum of 8 doses. RESULTS: One hundred and four pregnant women underwent induction of labor with oral misoprostol for late-term pregnancy on the 290th day of gestation. Study population was divided in two groups based on age (<35 and ≥35 years) and obesity (BMI <30 and ≥30). No statistically significant differences were recorded between younger and older women. Obese women reported a longer time between the last dose of misoprostol and cervical dilation of 6 cm (p = 0.01), a longer time between the last dose of misoprostol and delivery (p = 0.04), and a higher rate of grade II vaginal lacerations (p = 0.02). CONCLUSIONS: Maternal BMI is a factor negatively influencing the efficacy of oral misoprostol for induction of labor in late-term pregnancy.

[Comparison of vaginal prostaglandins with oral misoprostol as a second line of cervical ripening after using a cervical balloon catheter]. / Comparaison des prostaglandines vaginales au misoprostol oral en 2e ligne de maturation cervicale après recours à un ballonnet de dilatation cervicale.

OBJECTIVE: To compare vaginal prostaglandins with oral misoprostol as a second line of cervical ripening after using a cervical balloon catheter. MATERIAL AND METHODS: This is a retrospective monocentric study (Lille, France), according to a "before"/"after" design. The inclusion criteria were a singleton pregnancy, with a fetus in cephalic presentation, a term >37 WA, with a cervix having a Bishop score lower than 6 after a first line of maturation by cervical balloon catheter. Two groups were formed: "before" corresponding to the continuation of maturation by vaginal prostaglandins, from March 2019 to November 2019, and "after": corresponding to the continuation of maturation by oral misoprostol, from June 2020 to December 2020. The primary outcome was vaginal delivery rate. RESULTS: One hundred women were included in each group. The rate of vaginal delivery was similar between the 2 groups (76% vs 81%, p=0.39), as were the times between the start of induction and the birth and between the start of induction and the transition to birth room. There was no difference in the indication for caesarean section, with in particular an identical rate of caesarean sections for induction failure (p=0.52). Subgroup analysis in obese women showed a significantly higher rate of vaginal delivery in the "after" group (OR=4.17;95% CI [1.02;17.07]). CONCLUSION: The vaginal delivery rate is similar when using vaginal prostaglandins or oral misoprostol as second line cervical ripening after use of a cervical balloon catheter.

Comparison of the Efficacy and Safety of Sublingual Versus Oral Misoprostol for the Induction of Labor: A Randomized Open-Label Study.

Introduction Misoprostol (prostaglandin E1 analog) is being used for the induction of labor by vaginal, oral, and sublingual routes. Oral misoprostol is the preferred route for induction of labor, but the use of sublingual misoprostol appears promising due to a faster onset of action. This study was done to compare the efficacy and safety of oral and sublingual misoprostol for induction of labor in term pregnancy. Materials and methods One hundred and sixty patients were randomly allocated to one of the two groups to receive 50 micrograms of oral and sublingual misoprostol four hourly for a maximum of six doses. Primigravida at 37-42 weeks of gestation with singleton pregnancy, cephalic presentation, Bishop score (<5), and reassuring fetal heart rate were included in the study. Misoprostol dose was withheld if the active phase of labor was reached or if the cervix was favorable for amniotomy (Bishop score greater than or equal to eight). The change in the Bishop score with misoprostol was studied along with adverse effects and neonatal outcomes. Results The mean number of 50 mcg misoprostol doses required was significantly less in the sublingual group (2.94±0.97 versus 2.13±0.92; p<0.0001). The rate of change of the mean Bishop score was faster in the sublingual group. After four hours of the first dose, the mean Bishop score changed to 3.52±2.14 versus 4.68±2.34 (p=0.001), and, similarly, after eight hours, it was 10.48±2.59 versus 11.39±2.06, and this difference was statistically significant (p=0.015). The mean induction delivery interval was significantly lower in the sublingual group. The need for labor augmentation, mode of delivery, and adverse effects were similar in both groups. The incidence of meconium-stained liquor and NICU admission was also similar in both groups. Conclusion Sublingmisoprostolstol has a short induction delivery interval and comparable side effects when compared to omisoprostolstol. Sublingmisoprostolstol is recommended for induction of labor at term.

Effect of maternal age and body mass index on induction of labor with oral misoprostol for premature rupture of membrane at term: A retrospective cross-sectional study.

The aim of this study was to evaluate the effect of maternal age and body mass index (BMI) on induction of labor with oral misoprostol for premature rupture of membrane (PROM) at term. We have conducted retrospective cross-sectional study, including only term (37 weeks or more of gestation) PROM in healthy nulliparous women with a negative vaginal-rectal swab for group B streptococcus, a single cephalic fetus with normal birthweight, and uneventful pregnancy that were induced after 24 h from PROM. Ninety-one patients were included. According to the multivariate logistic regression, age and BMI odds ratio (OR) for induction success were 0.795 and 0.857, respectively. The study population was divided into two groups based on age (<35 and ≥35 years) and obesity (BMI <30 and ≥30). Older women reported a higher induction failure rate (p < 0.001); longer time to cervical dilation of 6 cm (p = 0.03) and delivery (p < 0.001). Obese women reported a higher induction failure rate (p = 0.01); number of misoprostol doses (p = 0.03), longer time of induction (p = 0.03) to cervical dilatation of 6 cm (p < 0.001), and delivery (p < 0.001); and higher cesarean section (p = 0.012) and episiotomy rate (p = 0.007). In conclusion, maternal age and BMI are two of the main factors that influence oral misoprostol efficacy and affect the failure of induction rate in term PROM.

Comparison of the effect of oral and vaginal misoprostol on labor induction: updating a systematic review and meta-analysis of interventional studies.

OBJECTIVES: This study is aimed to compare the effect of oral misoprostol with vaginal misoprostol to induce labor as a systematic review and meta-analysis. METHODS: Electronic databases including PubMed [Medline], Scopus, Web of science, Embase, Ovid, Cochrane library, and ClinicalTrials.gov were searched using the relevant keywords. All RCTs comparing the effect of oral vs vaginal misoprostol on labor induction were considered. The Cochrane Risk of Bias checklist was used for assessing quality of included RCTs. All statistical analyses were completed using STATA (Version 16) and Revman (Version 5). RESULTS: Thirty-three RCTs with 5162 patients (1560 in oral and 2602 in vaginal groups) were included in this meta-analysis. Labor induction length did differ significantly between the two routes of misoprostol administration [Standardized Mean Difference: 0.40 h, 95% confidence interval (CI) 0.34, 0.46; I2: 66.35%; P = 0.04]. In addition, the risk of neonatal death, tachysystole, uterine hyperstimulation, preeclampsia, non-FHR and abortion was lower in the oral misoprostol group and the risk of hypertonus, PROM, oxytocin need and cesarean fever was higher in this group than the vaginal misoprostol group. CONCLUSIONS: Based on results of this meta-analysis, it can be inferred that currently, clinical specialists can decide to use this drug orally or vaginally on a case-by-case basis, depending on the condition of the pregnant mother and the baby.

Sublingual misoprostol vs. oral misoprostol solution for induction of labor: A retrospective study.

Introduction: Induction of labor (IOL) is one of the most common obstetrical procedures, with an increasing rate. The prostaglandin E1 analogue misoprostol is frequently used as a primary method of labor induction. The optimal dose and route of administration is yet to be ascertained. Aim: To compare efficiacy and safety between a regimen of sublingually administered misoprostol and a regimen of orally administered misoprostol, with cesarean delivery as primary outcome. Methods: A retrospective study was conducted including women carrying a live, singleton fetus in a cephalic position with labor induced at >37 + 0 gestational weeks at Skåne University hospital, Lund, between January 1st 2013 to December 31st 2017. Data was obtained from computerized obstetrical charts. Results: Totally 2,404 women were included; 974 induced with sublingual misoprostol and 1,430 with oral solution. In primiparous women the cesarean delivery rate was lower in primiparous women induced with oral compared to sublingual misoprostol (20.5% vs. 28.6%, p < 0.001), whereas in parous women the rates did not differ significantly 4.9% vs. 7.5%; NS). The increased risk of caesarean remained after controlling for potential confounding factors (adjusted odds ratio 1.49 (1.14-1.95). Women induced with sublingual misoprostol had a shorter time to vaginal delivery when compared to oral solution (primiparous median 16.7 h vs. 21.7 h; p < 0.001, parous median 9.9 h vs. 13.3 h; p = 0.01), and a higher rate of vaginal delivery within 24 h (primiparas 77.7% vs. 63.3%, p < 0.001, parous 93.2% vs. 84.2%; p = 0.01). Conclusion: IOL with oral misoprostol solution was associated with a significantly higher vaginal delivery rate when compared to sublingual misoprostol, whereas sublingual misoprostol was associated with a significantly shorter time from induction to vaginal delivery. Oral administration is considered the most safe and efficient administration of misoprostol, although more studies are needed to find the optimal route and dosage of misoprostol for IOL.

Oral Misoprostol for the Induction of Labor: Comparison of Different Dosage Schemes With Respect to Maternal and Fetal Outcome in Patients Beyond 34 Weeks of Pregnancy.

BACKGROUND/AIM: Labor is induced in 1 out of 5 pregnancies. This is why we aimed to compare two different protocols of orally administered misoprostol for the induction of labor (IOL), with special regard to maternal and fetal outcome, delivery mode and duration. PATIENTS AND METHODS: One hundred and twenty four patients with a medical indication for IOL were divided into two groups: Group A (n=63), which initially received 50 µg misoprostol escalated to 100 and, subsequently, to 200 µg every 4 h with a daily maximum of 600µg, between 11/2007 and 01/2008; and Group B (n=61), which initially received 25 µg misoprostol followed by 100 µg every 4 h with a daily maximum of 300 µg, between 12/2009 and 04/2010. RESULTS: The mean administration-delivery interval was significantly lower in Group A (19.0 h) compared to Group B (27.1 h, p<0.05). Overall caesarean section rate, average birth weight, APGAR score, umbilical cord pH and meconium-stained fluid rates were similar between both groups. CONCLUSION: A higher dosage protocol of orally administered misoprostol significantly reduces the mean induction-delivery interval without increasing the risk for an adverse maternal or fetal outcome.

Oral misoprostol tablets (25 µg) for induction of labor: a targeted literature review and cost analysis.

BACKGROUND: Various methods exist for the induction of labor (IOL), and there is limited consensus as to optimal methods. Off-label misoprostol is recommended by the World Health Organization (WHO) for IOL but preparing it into doses suitable for IOL lacks precision, with potential adverse outcomes if dosing is inaccurate. This study explores potential outcomes and costs associated with increased uptake of a low-dose (25 µg) oral misoprostol formulation (Angusta; Norgine BV, Amsterdam) approved for IOL, in France, Belgium, and the Netherlands. METHODS: A literature review was undertaken to derive probabilities of delivery outcomes (vaginal, instrumental, and cesarean sections) for IOL methods, from published meta-analyses. Outcomes for oral misoprostol tablets (25 µg) were unavailable in the meta-analyses, so were estimated using data from two published retrospective cohort studies. A model was developed to predict the frequency of IOL outcomes and associated costs at the national level, across multiple scenarios. Scenarios were tested using a moderate, medium, and high increase in oral misoprostol tablet (25 µg) uptake. Market shares, costs, and induction rates were defined for each country using multiple data sources. RESULTS: Increased uptake of oral misoprostol tablets (25 µg) was estimated to be associated with a slightly increased rate of routine vaginal deliveries, and concurrent decreases in instrumental vaginal deliveries and cesarean sections. Since routine vaginal deliveries are less costly than other delivery outcomes, increased uptake of oral misoprostol tablets (25 µg) within the IOL market has the potential to be cost-saving. These trends were predicted using 25 µg oral misoprostol tablet outcomes informed by both retrospective studies. CONCLUSION: Preliminary outcomes suggest that oral misoprostol tablets at 25 µg per dose may improve outcomes in IOL and be cost-saving. Further study is required to validate these findings and assess the comparative efficacy of IOL methods, including oral misoprostol tablets (25 µg).

[Induction of labour with oral misoprostol versus vaginal misoprostol: A before-after study]. / Induction du travail par misoprostol oral versus misoprostol vaginal : étude avant-après.

OBJECTIVE: The rate of induction of labor represented 22 % of deliveries in 2016 in France. Oral misoprostol (Angusta®) was marketed in France in the last quarter of 2018. The objective of our study was to compare the efficacy and safety of induction of labor with oral misoprostol compared to vaginal misoprostol in women with an unripe cervix. MATERIAL AND METHODS: We carried out a retrospective study before and after the implementation of oral misoprostol including all women with an unripe cervix who benefited from an induction of labor with a viable infant in vertex presentation, without uterine scar. During the first two-year period, women received 50µg of misoprostol in the posterior fornix, repeated 6hours later if needed. If labor had not started after 24hours, women received another dose of 50µg, which was repeated every 4hours until labor was established, up to a total dose of 150µg. During the second two-year period, women received two tablets of oral misoprostol 25µg every four hours if necessary, up to a total dose of 200µg. The primary endpoints were mode of delivery and neonatal safety. RESULTS: During the two study periods, 1199 women received vaginal misoprostol and 1199 women received oral misoprostol including. The cesarean delivery rate was 21.8% during the first period and 21,3% during the second period (P=0.83). A 5-minutes Apgar score<7 was observed in 23 (1.9%) and 14 (1.2%) newborns in the vaginal misoprostol and oral misoprostol groups (P=0.14), respectively. An arterial cord pH<7.00 was observed in 6 (0.5%) and 7 (0.6%) newborns (P=0.99), respectively. CONCLUSION: Oral misoprostol administered at the dose of 50µg every 4hours (up to a total dose of 200µg) is as effective and safe as the vaginal misoprostol to induce labor in women with an unripe cervix.

Women's body mass index and oral administration of Misoprostol for induction of labor - A retrospective cohort study.

Pregnant women who are obese are at greater risk of pregnancy complications, including preeclampsia, gestational diabetes, and macrosomia, leading to an increased likelihood of induced labor. Little is known about pregnant women with obesity and the dose of Misoprostol needed for induction of labor (IOL). To investigate whether the cumulative dose of Misoprostol needed for induction of labor (IOL) is associated with women's body mass index (BMI), we conducted a retrospective study of the use of oral Misoprostol for IOL at the Department of Obstetrics and Gynecology, Aarhus University Hospital - a tertiary referral delivery unit with 4800 deliveries a year. Data on IOL among 1637 women with singleton pregnancies was collected in the period January 1st, 2014, to October 4th, 2017. Low-risk women were induced in an outpatient setting. Primary outcomes were Misoprostol dose, time between start of induction (first dose of Angusta®) and completed delivery, and mode of delivery. Secondary outcomes were neonatal data as Apgar score and pH of the umbilical artery. In this study, we found the total dose of Misoprostol needed for induction increased significantly with increasing BMI (p < 0.005). The time to delivery and the risk of Cesarean section increased with rising BMI class. However, 76% of inductions among the women with obesity ended in a vaginal delivery. For the neonatal outcomes, a total of 16 children had an Apgar score below 7 at five minutes and 14 had a pH less than 7.0; none of these results differed significantly between BMI classes. The perinatal and maternal mortality rate was 0%.

Safety and efficacy of an oral misoprostol standard-dose regimen vs a low-dose regimen for induction of labour in Papua New Guinean women: An open-label randomised controlled trial.

BACKGROUND: Oral misoprostol is widely used for induction of labour (IOL) in developing countries because of its many advantages. However, limited data exist concerning its safety and efficacy when lower doses are used. AIM: To determine the safety and efficacy of a low-dose oral misoprostol regimen (commencing at 12 µg) compared to a standard-dose regimen (commencing at 25 µg) in Papua New Guinea (PNG) women undergoing IOL. MATERIALS AND METHODS: This was an open-label non-inferiority randomised controlled trial conducted at a provincial hospital in PNG. Women with singleton pregnancies ≥36 weeks with cephalic presentation and a Bishops score of <6, requiring IOL were enrolled. Both regimens were incremented second-hourly to a maximum required dose within 24 h or until commencement of labour. The primary outcome was the proportion of women who delivered within 24 h of drug administration without any severe adverse events. RESULTS: Of the 262 women induced (130 standard-dose vs 132 low-dose), rates of successful induction were high for both regimens (120/130 (92%) vs 118/132 (89%); P = 0.52). Fourteen women (11%) in the standard-dose regimen and 20 (15%) in the low-dose regimen had severe adverse events. There was no significant difference in the safety profile of the two regimens (106/130 (82%) vs 98/132 (74%); P = 0.18). The induction-to-delivery time was significantly shorter in the standard-dose arm (15.2 ± 8.7 h vs 18.0 ± 9.1 h; P = 0.01). CONCLUSION: The standard-dose regimen for IOL has greater efficacy in reducing induction-to-delivery time compared to the low-dose regimen. There was no significant difference in the number of adverse events between the two regimens.

Oral misoprostol for induction of labor at term: a randomized controlled trial of hourly titrated and 2 hourly static oral misoprostol solution.

Background: Misoprostol has been shown to be effective in induction of labor (IOL) with different dosages and routes of administration.Objectives: This study compared the efficacy and safety of hourly titrated and 2-hourly static low dose oral misoprostol for IOL in Ekiti State University Teaching Hospital, Ado-Ekiti.Methods: One hundred fifty women with singleton pregnancy at term admitted for IOL were randomized into the two groups. Oxytocin augmentation was done as necessary. The primary outcome is rate of vaginal delivery within 24 hours. Data were analyzed using SPSS.Results: Vaginal delivery was achieved within 24 hours in 40 (67.8%) women who received hourly titrated-doses oral misoprostol and 42 (70.0%) women who received 2-hourly static-dose of oral misoprostol, p > .05. The rate of vaginal delivery, oxytocin augmentation, induction delivery time and cesarean section rate were similar in both groups, p > .05. Occurrence of uterine hyperactivity did not differ significantly among the women (p > .05) and no cases of uterine rupture were recorded. There were no adverse neonatal outcomes.Conclusions: The hourly titrated oral misoprostol is as effective and safe as the 2-hourly static oral misoprostol for IOL. Both can be utilized in IOL without the fear of adverse outcomes.

Safety and efficacy of titrated oral misoprostol solution versus vaginal dinoprostone for induction of labor: A single-center randomized control trial.

OBJECTIVE: To compare the efficacy and safety of the hourly administration of titrated oral misoprostol solution (OMS) and vaginal dinoprostone for induction of labor. METHODS: Titrated OMS was administrated hourly for induction of labor, starting with a dose of 20 µg and terminating at a dose of 50 µg. The safety and efficacy of OMS were compared with that of vaginal dinoprostone for induction of labor. RESULTS: From June 2016 to October 2019, 2280 (78.3%) and 2115 (72.9%) women who received titrated OMS and vaginal dinoprostone, respectively, had a vaginal delivery (P = 0.005). Cesarean delivery was performed in 632 (21.7%) and 783 (27.0%) women who received titrated OMS and vaginal dinoprostone, respectively (P = 0.008). Tachysystole with changes in fetal heart rate (FHR) was seen in 104 (3.6%) and 249 (8.6%) women in the OMS and dinoprostone groups, respectively (P = 0.007). The frequency of non-reassuring FHR was lower in the OMS group compared to the dinoprostone group (P = 0.006). CONCLUSION: The titrated OMS has an efficacy comparable to vaginal dinoprostone. Moreover, it causes a lower incidence of cesarean delivery, lower frequency of tachysystole with changes in FHR, and non-reassuring FHR.

Do we need a 200 µg misoprostol vaginal insert? A retrospective cohort study comparing the misoprostol vaginal insert to oral misoprostol.

AIM: The misoprostol vaginal insert (MVI) was reported to be more effective than dinoprostone but discussed critically because of high rates of fetal heart rate changes due to uterine tachysystole. The aim of this study was to investigate the outcome of induced labor using the MVI compared to off-label orally-administered misoprostol (OM). METHODS: Retrospective study including a total of 401 patients with singleton pregnancies in whom labor was induced at ≥36 0/7 gestational weeks with MVI (203) or OM (198). Primary outcomes were the time from induction to delivery, vaginal delivery in 24 h and the mode of delivery and the neonatal outcome. RESULTS: Median time until any delivery was 833 min (645-1278) for MVI and 1076.5 min (698-1686.3) for OM group; 83.7% of the patients in the MVI group gave birth within 24 h versus 63.6% in the OM group. The MVI group needed significantly less pre-delivery oxytocin (29%). Tachysystole (6.4%) and pathological CTG (30.5%) occurred at a significantly higher frequency in the MVI group. The cesarean section rate was significantly higher in the MVI group amounting to 21.7% versus 14.6% in the OM group (P < 0.05). Neonatal outcome did not differ between the groups. CONCLUSION: The MVI might be an option if you are in need for an approved and faster method to induce labor. Although we observed a significantly higher rate of fetal heart rate changes and cesarean sections in the MVI group this did not affect the neonatal outcome.

An audit of oral administration of Angusta® (misoprostol) 25 µg for induction of labor in 976 consecutive women with a singleton pregnancy in a university hospital in Denmark.

INTRODUCTION: Induction of labor (IOL) is used to improve the outcome of pregnancy for mother and child. Since 2013, oral misoprostol has been used for IOL at Aarhus University Hospital, Denmark. The purpose of the present paper is to describe our experience of the use of a new, 25-µg misoprostol tablet commercially manufactured for the purpose of IOL regarding efficacy and outcome for mother and neonate in both an inpatient and an outpatient regimen. MATERIAL AND METHODS: We performed an audit from 1 April 2016, including data on all IOL in women with singleton pregnancies until 1000 consecutive women were registered. Data from 976 consecutive women with gestational age ≥37+0  weeks induced in accordance with the "Aarhus protocol" were included in the present analyses. All inductions were by oral misoprostol. Outpatient induction is standard procedure in low-risk pregnancies, that is, pregnancies with a healthy mother and no signs of placental insufficiency. In the outpatient IOL, the first dose of misoprostol is administered after a normal cardiotocography registration at the hospital. Subsequent doses are taken at home according to a predefined regimen. Following delivery, data on baseline variables and outcome variables for the mother and neonate were retrieved from the medical records. RESULTS: In 71.9% of cases, the women were induced in an outpatient regimen. Delivery within 24 hours was achieved in 38.8% of women (nulliparous 32.3%, multiparous 50.9%) and within 48 hours in 70.1% (nulliparous 66.2%, multiparous 77.2%). Hyperstimulation during induction occurred in 0.6%. The mode of delivery was spontaneous vaginal in 75.5% of cases. The cesarean section rate was 14.9% (nulliparous 20.7%, multiparous 4.1%). Apgar <7 at 5 minutes and pH <7.0 in the umbilical artery was seen in 0.9% and 0.7%, respectively. CONCLUSIONS: Induction of labor by a commercially produced low-dose (25 µg) misoprostol tablet for oral induction according to the "Aarhus protocol" is feasible in an outpatient as well as an inpatient regimen. Delivery was achieved within 48 hours for 70.1% of women. Few adverse events were seen; however, the audit was underpowered for safety.

Is vaginal misoprostol more effective than oral misoprostol for cervical ripening in obese women?

Objective: To determine if vaginal misoprostol is more effective than oral misoprostol for cervical ripening in obese women.Study design: A retrospective cohort study of obese women undergoing induction of labor from Jan 2013 to Dec 2016 with singleton, viable pregnancies beyond 37 completed weeks of gestational age. Women with an initial Bishop score of 7 or less, with a cervical dilatation of less than 2 cm, who received either vaginal or oral misoprostol as a cervical ripening agent, were included. Primary outcome was interval from the start of induction to the attainment of 3 cm cervical dilatation. Secondary outcomes included the interval from the start of induction to delivery and the rate of cesarean delivery (CD).Result: Of women who met the inclusion criteria, 966 (75.5%) women received oral misoprostol and 314 (24.5%) received vaginal misoprostol. The mean time-interval from the start of induction to attainment of 3-cm dilatation was shorter in the vaginal group (10.5 ± 10.4 h) compared to the oral group (17.2 ± 11.5 h), (p < .0001). Significantly shorter times to delivery were also noted in the vaginal group (17.4 h for vaginal vs. 24.8 h for oral, p < .0001). In the subgroup analysis of nulliparous women, shorter time intervals from the start of induction to attainment of 3-cm dilatation, as well as to delivery, were noted in the vaginal misoprostol group (p < .0001 for both). Multiple linear regression model confirmed route of misoprostol administration as an independent variable in predicting the outcomes (time from start of induction to 3 cm as well as to delivery). Significant findings amongst neonatal outcomes included lower umbilical artery pH and higher rates of neonatal jaundice in the oral misoprostol group.Conclusion: In a population of obese women undergoing induction of labor, vaginal administration of misoprostol was associated shorter time intervals from the start of induction to the attainment of 3 cm of dilatation, as well as to delivery, without increasing the rate of cesarean deliveries or the incidence of adverse maternal and neonatal outcomes.

Induction of labor with high- or low-dosage oral misoprostol-A Danish descriptive retrospective cohort study 2015-16.

INTRODUCTION: In Denmark, the rate of induced labor from 37 gestational weeks has increased by 108% from 12.4% in 2000 to 25.1% in 2012, and today more than 1 in 4 deliveries are induced. Standard procedure at North Zealand Hospital changed in 2016 from a dosage of 50 µg oral misoprostol 2-3 times daily, to 25 µg up to 8 times daily. Also, since 2016 healthy women with uncomplicated pregnancies (primiparous and multiparous) have been offered induction as an outpatient procedure. This study aimed to compare the current low-dosage procedure (25 µg) with the former high-dosage procedure (50 µg) in terms of induction to delivery time, maternal and fetal outcomes, and risk of uterine hyperstimulation. MATERIAL AND METHODS: Data from June 2015 to October 2016 were included. Comparable baseline, demographic, and obstetric data for women induced according to high-dosage or low-dosage protocols were retrieved from local medical files. Descriptive statistics, Pearson's chi-squared tests, Kaplan-Meier survival estimates, and logistic regression analyses were performed. RESULTS: The study included 816 induced deliveries. The high- and low-dosage groups differed in rates of plurality and place of induction. Induction to delivery times lasting longer than 72 hours were significantly decreased in the low-dosage group (adjusted odds ratio [aOR] 0.48, 95% confidence interval [95% CI] 0.27 to 0.86). Women in the low-dosage group also less often needed additional induction (P = 0.02), and the rate of uterine hyperstimulation was low irrespective of protocol (1% vs 3%, P = 0.16). There were no cases of uterine rupture in either group. The probability of vaginal delivery in the low-dosage group increased (adjusted hazard ratio 1.27, 95% CI 1.08 to 1.49), as did the risk of delivery with vacuum extraction (aOR 2.27, 95% CI 1.24 to 4.15), whereas delivery by cesarean section slightly decreased (aOR 0.89, 95% CI 0.59 to 1.33). The risk of meconium-stained liquor was nonsignificantly decreased (aOR 0.82, 95% CI 0.55 to 1.23). CONCLUSIONS: The low-dosage induction protocol was associated with favorable obstetric outcomes in terms of increased probability of vaginal delivery, but with higher risk of vacuum extraction. Protracted inductions and additional nonmedical interventions were reduced. There were no cases of uterine rupture. Statistically nonsignificant, the risk of uterine hyperstimulation was increased whereas the risk of meconium-stained liquor and of cesarean section was slightly decreased.

Home-Based Extended Low-Dose Oral Misoprostol in Management of First-Trimester Pregnancy Loss in Low-Resource Communities: A Randomized Trial.

OBJECTIVE: To investigate the efficacy, safety and tolerability of a home-based extended low-dose oral misoprostol for management of first-trimester pregnancy loss. MATERIALS AND METHODS: A randomized trial that was conducted in the Woman's Health University Hospital and El-eman Maternity Hospital, Assiut, Egypt. One hundred and sixty patients were included. They were randomly assigned to receive four tablets of 200 µg misoprostol vaginally (max. 800 µg-hospital group) or 12 tablets orally, one every 3 h, over 2 consecutive days (max. 2400 µg-extended low-dose home group). For failed first dose, another similar second dose was given. Primary outcome measure was the percentage of patients with 'medically completed miscarriages' in each group (including complete miscarriages + incomplete miscarriages with successful post-miscarriage misoprostol). RESULTS: The total number of patients with 'medically completed miscarriages' in home group was 65/79 (82.3%), which was comparable to the hospital group (52/71 or 73.2%) (P = 0.182). However, the majority of patients in home group had significantly successful miscarriages after a single course of low-dose oral misoprostol, experienced much less heavy bleeding attacks and had less systemic side effects. CONCLUSION: In low-resource communities, the home-based extended low-dose oral misoprostol protocol proved high efficacy, safety and tolerability in management of first-trimester pregnancy loss.

Comparison of Effectiveness and Patient Satisfaction of Vaginal Versus Oral Misoprostol in Treatment of Missed Miscarriage.

BACKGROUND: In recent years' medical management with misoprostol is an effective alternative to surgical evacuation. But there is a dearth of evidence to reveal the effectiveness of the different routes of misoprostol and satisfaction rate among the patients treated with these routes. AIM: This study was conducted to compare the effectiveness and patient's satisfaction rate of vaginal versus oral misoprostol. METHODS: It was a prospective non-interventional study. One hundred women of having missed abortion confirmed by ultrasonography examination were enrolled in the trial. Fifty-eight subjects were administered 200 mcg of oral and 42 subjects received 200 mcg of vaginal misoprostol every four hours up to four doses. If complete expulsion did not occur 12 hours after the last dose, the surgical evacuation was done. RESULTS: There was no significant statistical difference between the effectiveness of treatment with vaginal (78.57%) and oral misoprostol (79.31%) (p = 0.928). The difference between Patients' satisfaction at the time of discharge for the vaginal group (64.29%) and oral group (65.52%) was not statistically significant (P = 0.991). There was an increase in patients' satisfaction for both groups at the follow-up session, but still, the difference was not significant (P = 0.897). CONCLUSION: This study confirms that there is no statistical difference between the effectiveness and patient satisfaction of oral and vaginal misoprostol in the treatment of missed abortion.

Vaginal assessment and expedited amniotomy in oral misoprostol labor induction in nulliparas: a randomized trial.

BACKGROUND: Labor is induced in 20-30% of maternities, with an increasing trend of use. Labor induction with oral misoprostol is associated with reduced risk of cesarean deliveries and has a safety and effectiveness profile comparable to those of mechanical methods such as Foley catheter use. Labor induction in nulliparous women continues to be challenging, with the process often quite protracted. The eventual cesarean delivery rate is high, particularly when the cervix is unfavorable and ripening is required. Vaginal examination can cause discomfort and emotional distress particularly to nulliparous women, and plausibly can affect patient satisfaction with the induction and birth process. OBJECTIVE: The aim of this study was to evaluate regular (4-hourly prior to each oral misoprostol dose with amniotomy when feasible) compared with restricted (only if indicated) vaginal assessments during labor induction with oral misoprostol in term nulliparous women MATERIALS AND METHODS: We performed a randomized trial between November 2016 and September 2017 in a university hospital in Malaysia. Our oral misoprostol labor induction regimen comprised 50 µg of misoprostol administered 4 hourly for up to 3 doses in the first 24 hours. Participants assigned to regular assessment had vaginal examinations before each 4-hourly misoprostol dose with a view to amniotomy as soon as it was feasible. Participants in the restricted arm had vaginal examinations only if indicated. Primary outcomes were patient satisfaction with the birth process (using an 11-point visual numerical rating scale), induction to vaginal delivery interval, and vaginal delivery rate at 24 hours. RESULTS: Data from 204 participants (101 regular, 103 restricted) were analyzed. The patient satisfaction score with the birth process was as follows (median [interquartile range]): 7 [6-9] vs 8 [6-10], P = .15. The interval of induction to vaginal delivery (mean ± standard deviation) was 24.3 ± 12.8 vs 31.1 ± 15.0 hours (P = .013). The vaginal delivery rate at 24 hours was 27.7% vs 20.4%; (relative risk [RR], 1.4; 95% confidence interval [CI], 0.8-2.3; P = .14) for the regular vs restricted arms, respectively. The cesarean delivery rate was 50% vs 43% (RR, 1.1; 95% CI, 0.9-1.5; P = .36). When assessed after delivery, participants' fidelity to their assigned vaginal examination schedule in a future labor induction was 45% vs 88% (RR, 0.5; 95% CI, 0.4-0.7; P < .001), and they would recommend their assigned schedule to a friend (47% vs 87%; RR, 0.6; 95% CI, 0.5-0.7; P < .001) in the regular compared with the restricted arms, respectively. CONCLUSION: Despite a shorter induction to vaginal delivery interval with regular vaginal examination and a similar vaginal delivery rate at 24 hours and birth process satisfaction score, women expressed a higher preference for the restricted examination schedule and were more likely to recommend such a schedule to a friend.