Misoprostol Vaginal Insert Research Articles

Comparison of Misoprostol for Labor Induction: Vaginal Insert Versus Oral Application Concerning Efficiency and Safety.

The aim of the present retrospective study was to examine the efficiency and safety of the induction of labor with Misoprostol, administered either vaginally or orally. This retrospective cohort study included pregnant women with a gestational age of ≥36 +0 weeks and a singleton pregnancy who underwent induction of labor with Misoprostol as vaginal insert or as tablet (oral) between January 2014 and January 2019 at the Department of Obstetrics and Gynecology of the University Hospital of Cologne. The objective of this study was to analyze the time until delivery and the maternal and neonatal outcomes. A total of 1,511 patients were included in this retrospective analysis, of whom 1,035 patients (68.5%) underwent induction of labor with a misoprostol vaginal insert (MVI) and 476 (31.5%) with tablets (oral misoprostol: OM). MVI significantly shortened the time from application to delivery (p<0.001) in comparison to OM, reduced the need for epidural anesthesia (EA) (p=0.018) without an increase in caesarean sections (CS) (p=1), ventouse deliveries (VD) (p=0.715), maternal birth injuries or a reduced neonatal outcome (APGAR-Score, umbilical cord pH). MVI is superior to OM in terms of efficiency (primary outcome: time from application to delivery) and is equally safe (primary outcome: CS rate). Our study, along with existing literature, highlights the need for further research, particularly regarding neonatal outcomes. Additionally, it underscores the importance of careful consideration when inducing labor and ensuring informed consent.

The Efficacy of Misoprostol Vaginal Inserts for Induction of Labor in Women with Very Unfavorable Cervices.

The purpose of the present study was to evaluate the effectiveness of a misoprostol vaginal insert as an induction-of-labor (IOL) agent in women with an unfavorable cervix (Bishop score < 2) in achieving vaginal delivery (VD) within 48 h, depending on the gestational week, with particular emphasis on the cesarean section (CS) percentage, intrapartum analgesia application and possible side effects, such as tachysystole ratio. In this retrospective observational study involving 6000 screened pregnant patients, 190 women (3%) fulfilled the study inclusion criteria and underwent vaginal misoprostol IOL. The pregnant women were collected into three groups: patients who delivered at up to 37 weeks of gestation (<37 Group)-42 patients; patients who delivered between 37 and 41 weeks of gestation (37-41 Group)-76 patients; and patients who delivered after 41 weeks of gestation (41+ Group)-72 patients. The outcomes included time to delivery and mode of delivery, rate of tachysystole, need for intrapartum analgesia, and need for oxytocin augmentation. Most of the patients delivered vaginally (54.8% in <37 Group vs. 57.9% in 37-41 Group vs. 61.1% in 41+ Group). A total of 89.5% (170/190) of patients delivered within 48 h (<37 Group-78.6% vs. 37-41 Group-89.5% vs. 41+ Group-95.8%). Statistical significance was demonstrated for the increased rate of vaginal deliveries and shortened time to delivery in the 41+ weeks group (p = 0.0026 and p = 0.0038). The indications for cesarean section were as follows: abnormal CTG pattern vs. lack of labor progression: 42.1% vs. 57.9% in <37 Group, 59.4% vs. 40.6% in 37-41 Group and 71.4% vs. 28.6% in 41+ Group. Statistical significance was demonstrated for the increased rate of abnormal CTG patterns as cesarean section indications in the 41+ Group (p = 0.0019). The need for oxytocin augmentation in each group was: 35.7% in <37 Group vs. 19.7% in 37-41 Group vs. 11.1% in 41+ Group. Statistical significance was shown for decreased need for oxytocin augmentation in +41 Group (p = 0.0016). The need for intrapartum anesthesia, depending on the group, was: 78.6% in <37 Group vs. 82.9% in 37-41 Group vs. 83.3% in 41+ Group. Statistical significance was demonstrated for increased need for intrapartum anesthesia application during labor in +41 Group (p = 0.0018). The prevalence of hyperstimulation was similar in all three groups (4.8% vs. 7.9% vs. 5.6% p > 0.05). The misoprostol vaginal regimen for IOL used in our study is effective in achieving vaginal delivery within 48 h. In post-term women, the use of this regimen is characterized by an increased rate of vaginal deliveries, a shorter time to delivery and a lower need for oxytocin.

Effectiveness of dinoprostone gel, misoprostol vaginal insert and dinoprostone vaginal insert for induction of labour in twin pregnancies

ObjectivesTo compare the effectiveness and safety of Dinoprostone Gel (DG), Misoprostol Vaginal Insert (MVI) and Dinoprostone Vaginal Insert (DVI) for induction of labour (IOL) in twin pregnancies. Study DesignRetrospective cohort study of twin pregnancies > 34 + 0 weeks gestation that underwent induction of labour (IOL) with DG, MVI or DVI between December 2016 and November 2019 in a Tertiary NHS hospital, North West England, UK. Delivery characteristics, maternal complications and neonatal outcomes were compared between the three groups. ResultsA total of 87 twin pregnancies were included for analysis. 27 women received DG, 34 received MVI and 26 DVI. The MVI cohort had a higher proportion of nulliparous women (55.9%) compared to the DG and DVI cohorts, 29.6% and 38.5% respectively. No other differences amongst demographic characteristics were considered clinically significant.DG demonstrated a significantly quicker time to delivery (minutes) compared to DVI (1021 ± 556 versus 1649 ± 852; P = 0.0026). Significantly fewer women required terbutaline for hyperstimulation/tachysystole in the DG group compared to MVI (0% vs 32%; RR 0.05; 95% CI 0.003–0.88). Both DG and MVI groups required significantly less oxytocin following artificial rupture of membranes compared to DVI (33% vs 65%; RR 0.51; 95% CI 0.28–0.93) and (29% vs 65%; RR 0.45; 95% CI 0.25–0.81). There were no significant differences in mode of delivery, maternal complications and neonatal outcomes. ConclusionOur data suggests that for women with a twin pregnancy considering a planned labour that induction with DG, MVI and DVI appear to be equally safe and effective IOL methods. These results should be interpreted with caution due to the study being underpowered to detect significant adverse outcomes. In order to determine the optimal method of IOL in twins, direct randomised comparison is needed.

Induction of Labor at Term with Oral Misoprostol or as a Vaginal Insert and Dinoprostone Vaginal Insert - A Multicenter Prospective Cohort Study.

Introduction The efficacy, safety, and perinatal outcome of oral misoprostol (OM), a misoprostol vaginal insert (MVI), and a dinoprostone vaginal insert (DVI) for induction of labor at term was examined in a prospective multicenter cohort study (ethics committee vote 4154–07/14). The primary aims of the study were the induction-birth interval (IBI), the cumulative delivery rates after 12 h, 24 h, and 48 h as well as the mode of delivery. Method 322 pregnant women were included in four German tertiary perinatal centers (MVI 110, DVI 64, OM 148). They did not vary in age or BMI. Statistical analysis was carried out using a multivariate linear regression analysis and binary logistic regression analysis. Results With regards to the median IBI, MVI and OM were equally effective and superior to the DVI (MVI 823 min [202, 5587]; DVI 1226 min [209, 4909]; OM 847 min [105, 5201]; p = 0.006). Within 24 hours, 64% were able to deliver with DVI, 85.5% with MVI and 87.5% with OM (p < 0.01). The rates of secondary Caesarean sections (MVI 24.5%; DVI 26.6%; OM 18.9%) did not differ significantly. Uterine tachysystole was found in 20% with MVI, 4.7% with DVI and 1.4% with OM (p < 0.001). A uterine rupture did not occur in any of the cases. Perinatal acidosis occurred (umbilical cord arterial pH < 7.10) in 8.3% with MVI, 4.7 with DVI and 1% with OM (p = 0.32). Neonatal condition was only impaired in three cases (5-minute Apgar score < 5). Summary Induction of labor at term using the prostaglandins misoprostol and dinoprostone is an effective intervention that is safe for the mother and child. Oral application of misoprostol demonstrated the highest efficacy while maintaining a favorable safety profile.

Healthy Foetuses. Misoprostol Insert Induction HF MIND. A multicentre Italian study on the misoprostol vaginal insert for induction of labour

Healthy Foetuses. Misoprostol Insert Induction HF MIND. A multicentre Italian study on the misoprostol vaginal insert for induction of labour

Pregnancy-related comorbidities and labor induction - the effectiveness and safety of dinoprostone compared to misoprostol.

The aim of the study was to evaluate whether the presence of the disease in pregnancy influences the effectiveness and safety of delivery preinduction with prostaglandins: misoprostol vaginal insert and dinoprostone vaginal gel. This is aretrospective cohort study conducted of 560 pregnant women. The concomitant diseases mainly recorded were diabetes mellitus, hypertensive diseases, intrahepatic cholestasis of pregnancy, asthma, thrombocytopenia, and hypothyroidism. The primary study outcome was a successful vaginal delivery. The study above others evaluates the time from treatment implementation to the beginning of a labor and to a final delivery, the rate of Cesarean sections, and the presence of delivery complications. Among women with a concomitant disease, Caesarean section was observed more frequently in the misoprostol group. In the dinoprostone group, mothers with the concomitant disease as compared to healthy mothers required more time to the delivery and to achieve the beginning of labor. There were no differences in postpartum complications regardless of the prostaglandins, comorbidities or mothers' age. Neonates of mothers ≥ 35 years old with concomitant disease had lower average Apgar scores. Our study showed that comorbidities seem to increase the caesarean section risk in the misoprostol preinduction group but in the dinoprostone group they prolong the time needed to achieve an active labour phase and a delivery.

Women\u2019s expectations and experiences of labor induction \u2013 a questionnaire-based analysis of a randomized controlled trial

BackgroundAlthough labor induction is a commonly used procedure in obstetrical care, there are limited data on its psycho-emotional effects on the woman. This study analysed the expectations and experiences of women in different routes of labor induction. The study’s primary aim was to compare women’s delivery experience if induced by orally administrated misoprostol (OMS) compared with misoprostol vaginal insert (MVI). Secondly, an evaluation of women’s general satisfaction with induced labor was made, and factors associated with a negative experience.MethodsPrimiparous women (n = 196) with a singleton fetus in cephalic presentation, ≥ 37 weeks of gestation, with a Bishop’s score ≤ 4 planning labor induction were randomly allocated to receive either OMS (Cytotec®) or MVI (Misodel®). Data were collected by validated questionnaires, the Wijma Delivery Expectation/Experience Questionnaire (A + B). The pre-labor part of the survey (W-DEQ version A) was given to participants to complete within 1 hour before the start of induction, and the post-labor part of the questionnaire (W-DEQ version B) was administered after birth and collected before the women were discharged from hospital.ResultsIt was found that 11.8% (17/143) reported a severe fear of childbirth (W-DEQ A score ≥ 85). Before the induction, women with extreme fear had 3.7 times increased risk of experiencing labor induction negatively (OR 3.7 [95% CI, 1.04–13.41]).ConclusionNo difference was identified between OMS and MVI when delivery experience among women induced to labor was analysed. Severe fear of childbirth before labor was a risk factor for a negative experience of labor induction.Trial registrationClinical trial register number NCT02918110. Date of registration on May 31, 2016.

Misoprostol vs dinoprostone vaginal insert in labour induction: comparison of obstetrical outcome

Induction of labour (IOL) is increasingly used in obstetric practice. For patients with unfavourable cervix, we are constantly looking for an optimal, in terms of effectiveness and safety, ripening of cervix protocol. It was retrospective cohort study. We analyzed obstetrical results in 481 patients undergoing IOL in one center using two different vaginal inserts that release prostaglandins at a constant rate for 24 h—misoprostol vaginal insert (MVI) with 200 µg of misoprostol (n = 367) and dinoprostone vaginal insert (DVI) with 10 mg of dinoprostone (n = 114). Full-term, single pregnancy patients with intact fetal membranes and the cervix evaluated in Bishop score ≤ 6 were included in the analysis. In the group of MVI patients, the labour ended with caesarean section more often (OR 2.71 95% CI 1.63–4.47) and more frequent unreassuring cardiotocographic trace indicating the surgical delivery occurred (OR 2.38 95% CI 1.10–5.17). We did not notice any differences in the percentage of vacuum extraction and patients in whom the use of oxytocin was necessary during labour induction. The clinical status of newborns after birth and the pH of cord blood did not differ between groups.The use of MVI 200 μg in patients with an unriped cervix is associated with a greater chance of completing delivery by caesarean section and increased chance of abnormal intrapartum CTG trace compared to the use of DVI 10 mg. These differences do not affect the clinical and biochemical status of the newborn.

Is Misoprostol Vaginal Insert Safe for the Induction of Labor in High-Risk Pregnancy Obese Women?

Induction of labor (IOL) is an event that occurs in up to 25% of pregnancies. In Europe, the misoprostol vaginal insert (MVI—Misodel®) was approved for labor induction in 2013. Studies on the outcomes and safety of IOL in obese pregnant women are scarce; no data are available on MVI IOL in high-risk pregnancy obese women (HRPO—late-term, hypertension, diabetes). As the obesity rates are growing steadily in pregnant women, we aimed to evaluate the failure rate for induction and the safety of a 200 μg MVI in obese (body mass index (BMI) >30 kg/m2) HRPO compared to that for obese non-high-risk pregnancies (non-HRPO). For this purpose, we conducted a cross-sectional study in “Filantropia” Clinical Hospital, Bucharest, Romania, from June 2017—the date of the initiation of the MVI IOL protocol in our clinic—to September 2019. The primary outcomes were the failure rate, measured by cesarean section (CS) ratio, and secondarily, the safety profile of MVI, analyzed by one-way ANOVA. Out of a total of 11,096 registered live births, IOL was performed on 206 obese patients. Of these, 74 obese pregnant women had their labor induced with MVI (HRPO, n = 57, and non-HRPO, n = 17). The average maternal age was 29.9 ± 4.8 years (19–44 years). Across the groups, the rate of CS was 29.8% (n = 17) in the HRPO group compared to 23.5% (n = 4) in the non-HRPO group (p = non significant). In the vaginally birth subgroups, the median time from drug administration to delivery was shorter in the HRPO group compared to the non-HRPO group (16.9 ± 6.0 h 95% confidence interval (CI) 15.0–18.8 vs. 19.4 ± 9.2 h 95% CI 13.8–25.0, p = 0.03). No significant differences were found regarding the maternal outcomes among the studied groups; in terms of perinatal outcomes of safety, 5.4% (n = 4) of the cases of vaginal delivery for HRPO were associated with neonatal intensive care unit (NICU) admissions. The MVI seems to be an efficient labor induction agent in high-risk pregnancy obese women with good maternal outcomes and low perinatologic complications.

Effect of Isosorbide Mononitrate and Misoprostol for Cervical Ripening in Induction of Labor

Background: Induction of labor has increased dramatically over the past two decades. Indications for induction of labor are either maternal (preeclampsia, pregnancy-induced hypertension) or fetal (post-term dates, growth retardation, ruptured membranes, diabetes). Objective: The purpose of this study was evaluation of the beneficial effect of isosorbide mononitrate and misoprostol for cervical ripening in induction of labor. Patients and Methods: A randomized clinical trial was carried out on 120 full-term pregnant women who were admitted for induction of labor in Zagazig University Hospitals in the period of July 2017 to March 2018. Patients were divided into two groups: Group A included 60 full term pregnant females who received 25 μg misoprostol (Vagiprost tablet) and placebo tablet in the posterior vaginal fornix. Group B included 60 full-term pregnant females who received vaginal 25 μg misoprostol (Vagiprost tablet) plus 40 mg isosorbide mononitrate (Effox tablet) in the posterior vaginal fornix. Results: There was little difference between the effectiveness of vaginal 25 mg misoprostol vaginal inserts and 40 mg isosorbide mononitrate vaginal inserts in induction of labor. The safety profiles of both drugs were similar, but isosorbide mononitrate administration is considered a low-risk method of labour induction for pregnant women at full term. Conclusions: The combination of misoprostol and isosorbide mononitrate may be more safe and effective for induction of cervical ripening in full-term pregnancy in comparison to misoprostol alone.

Efficacy and Safety of Misoprostol Vaginal Insert to Induce Labor beyond 40 + 0 Weeks of Gestation

Objective: Misoprostol vaginal insert (MVI) is proven to induce labor by a continuously release of PGE1. Previous reports showed that MVI reduced induction to delivery time as well as active labor time but it also increased uterine tachysystole. Here we attempted to clarify whether MVI is safe and efficient for women with pregnancies >40 weeks in a single institute. Methods: This study was performed in Lutheran Hospital Bergisch Gladbach, Germany 2014-2019. A total of 304 women between 40 + 0 to 42 + 0 weeks underwent labor induction with MVI. Outcomes were: 1) maternal: time from insertion to delivery, interventions, mode of delivery, and uterine tachysystole, 2) neo-natal: cord blood pH, APGAR scores, and admission to a neonatal clinic. This study ended unexpectedly due to the withdrawal of MVI (MisodelTM) in September 2019. Results: 75.7% (n = 230) of women gave birth within 24 hours after MVI placement. 72.2% (n = 140) nulliparous women and 81.8% (n = 90) parous women delivered within 24 hours. In two cases emergency CS was required. 67.8% (n = 206) of women delivered vaginal. 2.3% (n = 7) of cord pH levels were below 7.10. 3.3% (n = 10) of newborns were transmitted to a neonatal clinic. Conclusion: MVI is an efficient method to induce labor for pregnant women beyond 40 + 0 weeks. However, considering various complications observed (uterine tachysystole and fetal distress leading to a high number of CS), we cannot universally advocate the use of MVI.

Misoprostol vaginal insert and Foley catheter in labour induction — single center retrospective observational study of obstetrical outcome

Induction of labour is one of the most common procedures used in obstetrics and its prevalence tends to increase. In patients with an unripe cervix (Bishop score < 7) pre-induction procedures are used before the start of oxytocin induction. Currently there is no consensus among scientific societies on the optimal way of pre-induction. We have conducted a single-centre retrospective observational study comparing obstetric induction results of patients after 37 weeks of gestation who were pre-induced with misoprostol vaginal insert (MVI) with 200 μg of misoprostol (Misodel - Ferring Pharmaceuticals Poland) or Foley catheter (20 F, 60 mL baloon). We have reviewed the medical records of 503 patients (group A pre-induced MVI - 135 patients, group B pre-induced Foley catheter - 368 patients) who were in a single, full-term pregnancy, pre-induced due to unripe cervixes (Bishop score < 7) with a Foley catheter or Misodel (MVI 200 μg). We compared obstetric results between groups. Group A patients had a lower chance of using oxytocin in labour induction/augmentation (OR = 0.21 95% CI = 0.13-0.32), and a greater chance of surgical delivery by caesarean section (OR = 2.14 95% CI = 1.42-3.23) and vacuum extraction (OR = 3.29 95% CI = 1.08-10.00). Group A patients also had a greater chance of abnormal CTG (OR = 2.66 95% CI = 1.5-4.7) compared to group B. The groups did not differ in terms of meconium stained amniotic fluid and postpartum haemorrhage. The percentage of children born with a pH from umbilical cord blood < 7.2 and < 7.1 and newborns of medium general condition (Apgar 4-7) did not differ between the groups. Neonatological results of children from Foley catheters and MVI induced delivery do not differ. Patients pre-induced with MVI rarely require labour augmentation with oxytocin. MVI-preinduced patients have a better chance of having a delivery by CS or VE compared to the Foley catheter.

Is Unfavourable Cervix prior to Labor Induction Risk for Adverse Obstetrical Outcome in Time of Universal Ripening Agents Usage? Single Center Retrospective Observational Study.

Cervical assessment on the Bishop scale prior to induction of labor (IOL) is one of the strongest prognostic criteria in relation to the success of the procedure. The commonly used preinduction methods are mainly aimed at reducing the percentage of cesarean sections. Our study has analyzed obstetric results of patients who had unripe cervix (Bishop score <7) before IOL and used preinduction (Foley catheter or misoprostol vaginal insert releasing 7 mcg of misoprostol per hour for 24 hours) with obstetric results of patients in whom, due to favourable cervix, only a low-dose infusion of oxytocin was used. We reviewed the medical records of 1010 single pregnancies in whom IOL was performed. We divided the patients into two groups: group A (where preinduction was used) and group B (Bishop score ≥7 points) where preinduction was not used. Patients in group A were more likely to complete the delivery by caesarean section (OR = 4.58, 95% CI 3.22-6.51), and more likely to have events that were indications for operative delivery: unreassuring fetal heart rate trace (OR = 3.29, 95% CI 2.07-5.23) and arrested labor or failed induction (OR = 3.4, 95% CI 2.06-5.62). The groups did not differ in the percentage of vacuum extraction, postpartum haemorrhage, and meconium stained amniotic fluid. In group B, more infants were born with umbilical cord blood pH <7.1 (1.38% vs. 0%), both groups included no deliveries of newborns with Apgar score ≤3 points, the groups did not differ in terms of the percentage of newborns with Apgar score between 4 and 7 at birth (OR = 0.66, 95% CI 0.29-1.49). The immature cervix and the need to use labor preinduction is a risk factor for caesarean section. The necessity of preinduction does not impair neonatological results.

Tachysystole and risk of cesarean section after labor induction using misoprostol: A cohort study

ObjectivesTo investigate if tachysystole was associated with an increased risk of cesarean section or unfavorable maternal or neonatal outcomes following induction of labor by misoprostol vaginal inserts. Study designWe conducted a retrospective cohort study of 446 women over 37 weeks of gestation admitted for labor induction by misoprostol vaginal inserts between May 2016 and May 2017. Fetal heart rate and uterine activity tracings were assessed for tachysystole, defined as ≥ 6 contractions per 10 min, averaged over a 30-minute window. Univariate analysis was performed by using t-test and Chi-square, comparing demographics, pregnancy characteristics, intrapartum monitoring, mode of delivery, neonatal outcomes (Apgar score < 7 at 5 min, umbilical cord artery pH < 7.10, neonatal intensive care unit admission) and maternal outcomes, with regard to the presence of tachysystole. The association between tachysystole and cesarean section was evaluated after adjusting for potential confounders by a modified Poisson regression model, expressed as an adjusted risk ratio and 95 % confidence intervals. ResultsA total of 140 women (31.4 %) presented with tachysystole. The median duration of tachysystole was 2 h 12 min. The rate of cesarean section was 25.0 % (N = 35) among patients with tachysystole and 19.6 % (N = 60) for those without tachysystole. Presence of tachysystole during induction of labor with misoprostol vaginal inserts was not associated with cesarean section (adjusted risk ratio,1.0; 95 % confidence interval, 0.7–1.4). Neonatal and maternal outcomes were similar between mothers who did and did not experience tachysystole. ConclusionsThis study illustrates that tachysystole is not associated with an increased risk of cesarean section after induction of labor by misoprostol vaginal inserts. The impact of excessive uterine activity on the fetal wellbeing defined by the frequency of uterine contraction alone is probably insufficient. Further research on the development of accurate measures of uterine contractility is necessary to better understand its effect on fetal well-being.

Induction of labour in nulliparous women- quick or slow: a cohort study comparing slow-release vaginal insert with low-dose misoprostol oral tablets

BackgroundThis study was undertaken with the objective of comparing efficacy and safety for two different regimens using misoprostol for induction of labour.MethodsThe study was set in two different hospitals in the region of Zeeland, Denmark, and designed as a prospective cohort study. Nulliparous women with unripe cervix, eligible for vaginal delivery and medical induction of labour were included. Exclusion criteria were a previous uterine scar, suspicion of growth restriction of the fetus and prelabour rupture of membranes.One department used 25 mcg oral misoprostol tablets and the other department used 200 mcg slow-release misoprostol vaginal insert, for induction of labour.Primary outcomes were predefined as frequency of cesarean section, tachysystole and delivery within 24 h. Secondary outcomes were: time from induction to delivery, use of additional methods for induction, postpartum hemorrhage, anal sphincter rupture, epidural, pyrexia (rectal temperature > 38.5 °C), prolonged rupture of membranes, and use of tocolysis.ResultsNo significant differences in women achieving vaginal delivery was found. However, a significantly increased risk of tachysystole for the vaginal administration route was observed; 28.4% compared with 2.3%. There were no events of serious neonatal asphyxia. Half of the women induced with vaginal insert delivered within 24 h, compared with 16.8% of the women induced with oral misoprostol.ConclusionsInduction with vaginal slow-release misoprostol leads to quicker delivery with an increased risk of tachysystole but with similar perinatal outcomes and rates of cesarean sections. Low-dose oral misoprostol appears to be safe, however it leads to an increased use of secondary methods and a tendency of more intrapartum pyrexia.Trial registrationClinicaltrials.gov ID: NCT02693587 on February 262,016.EudraCT number 2020–000366-42 on 23 January 2020, retrospectively registered.

Misoprostol vaginal insert (Mysodelle) versus Dinoprostone intravaginal gel (Prostin) for induction of labour

ObjectiveThe aim of this study is the compare the effectiveness and safety of Misoprostol Vaginal Insert (Mysodelle) versus Dinoprostone intravaginal gel (Prostin) for induction of labour. Study designWe performed a prospective cohort study of the use of misoprostol vaginal inserts (Mysodelle) in the induction of pregnancy and compared it to a historical cohort of women induced with the Dinoprostone intravaginal gel (Prostin) at the Liverpool Women’s Hospital, a large UK teaching hospital. ResultsA total of 4102 women were induced between December 2016 and September 2018 of whom 2540 were induced with dinoprostone gel until September 2017. Since October 2017 1562 were induced using misoprostol vaginal inserts (MVI).The MVI demonstrated a significantly quicker median time to delivery compared with dinoprostone gel (18.2 h versus 21.8 h; p < 0.0001). There was a 32% reduced risk of Caesarean section with MVI (7.5% vs 10.9%; RR 0.62 95%CI 0.56–0.84) There was no significant difference in any of the key maternal or neonatal adverse outcomes. ConclusionsThe results of this study suggest that misoprostol vaginal inserts, compared with dinoprostone intravaginal gel, achieve quicker delivery times, and a reduction in caesarean sections with no increased rate of adverse maternal or neonatal outcomes.

Woman-Centred Induction of Labour (the WOCIL project)

Induction of labour (IOL) is a common obstetric intervention. 32% of women are induced per year in our obstetric unit. We were experiencing delays in starting IOLs due to unit...

The efficacy of misoprostol vaginal insert compared with oral misoprostol in the induction of labor of nulliparous women: A randomized national multicenter trial

Our objective was to compare the efficacy of a 200-μg misoprostol vaginal insert vs oral misoprostol regarding the cesarean section rate and the time interval to vaginal delivery in nulliparous women with unfavorable cervix. In this prospective multicenter trial, 283 nulliparous women at term with Bishop score <6 were randomized to induction of labor with either a misoprostol vaginal insert (n=140) or oral misoprostol (n=143). In the oral misoprostol group, a 50-μg dose of oral misoprostol was administered every 4 hours up to three times during the first day; during the second day, the dose was increased to 100-μg every 4 hours up to three times during the first day, if necessary. Primary outcome was the cesarean section rate. Secondary outcomes were the time from induction of labor to vaginal delivery, the rate of other induction methods needed, labor augmentation with oxytocin and/or amniotomy, use of tocolytics and adverse neonatal and maternal events. In the misoprostol vaginal insert group, median time to vaginal delivery was shorter (24.5hours vs 44.2hours, P<0.001), whereas no difference was found in the cesarean section rate (33.8% vs 29.6%, odds ratio [OR] 1.21, 95% confidence interval [CI] 0.66-1.91, P=0.67). Other induction methods and labor augmentation with oxytocin and/or amniotomy were less frequent in the misoprostol vaginal insert group (OR 0.32, 95% CI 0.18-0.59 and OR 0.56, 95% CI 0.32-0.99, respectively). Need for tocolysis and meconium-stained amniotic fluid were more common in the misoprostol vaginal insert group (OR 3.63, 95% CI 1.12-11.79 and OR 2.38, 95% CI 1.32-4.29, respectively). Maternal and neonatal adverse events did not differ between groups. Misoprostol vaginal insert proved to shorten the time to vaginal delivery and to reduce the use of other methods of labor induction and augmentation, but it did not reduce the cesarean section rate compared with oral misoprostol. The benefit of more rapid delivery associated with misoprostol vaginal insert should be weighed against the greater risks for uterine hyperstimulation and meconium-stained amniotic fluid.

Clinical experience with misoprostol vaginal insert for induction of labor: a prospective clinical observational study

PurposeTo provide real-world evidence using misoprostol vaginal insert (MVI) for induction of labor in nulliparous and parous women at two German Level I Centers in a prospective observational study.MethodsBetween 1 August 2014 and 1 October 2015, eligible pregnant women (≥ 36 + 0 weeks of gestation) requiring labor induction were treated with MVI. Endpoints included time to and mode of delivery rates of tocolysis use, tachysystole, uterine hypertonus or uterine hyperstimulation syndrome and newborn outcomes.ResultsOf the 354 women enrolled, 68.9% (244/354) achieved vaginal delivery (nulliparous, 139/232 [59.9%]; parous 105/122 [86.1%]; p < 0.001). Median time from MVI administration to vaginal delivery was 14.0 h (nulliparous, 14.5 h; parous, 11.9 h; p < 0.001). A total of 205/244 (84.0%) and 228/244 (93.4%) women achieved a vaginal delivery within 24 h and 30 h, respectively. The most common indications for cesarean delivery were pathologic cardiotocography (nulliparous, 41/232 [17.4%]; parous, 13/122 [10.7%]; p = 0.081) and arrested labor (dilation or descent; nulliparous, 45/232 [19.4%], parous, 3/122 [2.5%]; p ≤ 0.001). A total of 24.3% of women experienced uterine tachysystole and 9.6% experienced uterine tachysystole with fetal heart rate involvement, neither of which were significantly different for nulliparous and parous women. In total, 42/345 (12.2%) of the neonates had an arterial pH < 7.15 and 12/345 3.5% had a 5-min Apgar score ≤ 7.ConclusionWhen clinically indicated, MVI was efficient and safe for induction of labor in women with an unfavorable cervix. Women, however, should be counseled regarding the risk of uterine tachysystole prior to labor induction with MVI.

Efficacy and safety of misoprostol vaginal insert vs. oral misoprostol for induction of labor

Objectives To compare the oral application form of misoprostol with the misoprostol vaginal insert (MVI) in a Swiss cohort with special regards to the efficacy and safety. Methods We performed a retrospective case series including a historical group induced with oral misoprostol (MO, n=101) and an MVI group (n=101). The primary outcome was time to delivery. Secondary outcomes were mode of delivery, occurrence of tachysystole, use of analgesia and neonatal adverse outcome. Results A total of 202 women were included in the analysis (101 in the MVI as well as in the MO group). Time from start of induction to delivery was significantly shorter in the MVI group compared to the MO group (15.91 h vs. 37.68 h, P<0.001). Within the first 24 h, 78.2% of the women in the MVI group had given birth compared to 28.7% in the MO group (P<0.001). Tachysystole occurred more often in the MVI group (22.8% vs. 5.0%, P<0.001). Women in the MVI group more often needed opioid analgesia during the induction before onset of active labor (31.7% vs. 2.0%, P<0.001). There was no significant difference between neonatal outcomes in the two groups. Conclusion Time to delivery was significantly shorter in the MVI group with a higher rate of vaginal deliveries within the first 24 h. However, patients needed more opioids for pain relief during induction with MVI. There was no difference in neonatal outcomes.