A critical appraisal of the misoprostol removable, controlled-release vaginal delivery system of labor induction

Patte, Charlotte; Deruelle, Philippe

doi:10.2147/ijwh.s62372

Cited by 7 publications

(5 citation statements)

References 38 publications

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“…In order to overcome this limitation, a misoprostol vaginal insert (MVI) system was developed, comprising of a nonbiodegradable hydrogel polymer loaded with 200μg of PGE1 analog. MVI allows the release of misoprostol continuously for 24 hours (approximately 7μg/hour) while the insert remains in place, thus providing the correct dosing and reducing the incidence of adverse events, the reservoir being rapidly and easily removed if needed [16,29]. Misoprostol is extensively absorbed and rapidly metabolized to misoprostolic acid -the active metabolite, with approximately 80% excreted by the kidney with a terminal half-life of less than 1 hour when dosed vaginally, and peak plasma levels noted at around 5-9 hours.…”

Section: Discussionmentioning

confidence: 99%

A New Approach in the Induction of Labor with Misoprostol Vaginal Insert in High-Risk Pregnancy Obese Women

Varlas¹,

Bostan²,

Ba³

et al. 2020

Preprint

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Background and objectives: Induction of labor (IOL) is an event that occurs in up to one-quarter of pregnancies; less is known about the outcomes and safety of IOL in obese pregnant woman; no data is available on misoprostol vaginal insert (MVI) IOL in high-risk pregnancy obese women. Objectives: (1) to evaluate the rate of successful IOL with 200 μg MVI in obese (Body Mass Index - BMI over 30 kg/m2) high-risk pregnant women: late-term pregnancy, hypertension or diabetes, compared to obese non-high-risk ones; (2) to evaluate the safety profile of MVI in high-risk pregnancy obese patients. Study design: We conducted a cross-sectional study in "Filantropia" Clinical Hospital, Bucharest, Romania, from June 2017 to September 2019 (28 months). From a total of 11,096 registered live births, IOL was performed in 206 obese patients; 74 obese high-risk pregnant patients matched the inclusion criteria; of these, 33.8% pregnancies (n=25) were late-term (41 – 41+6 weeks), 43.2% (n=32) had associated pathologies (hypertension and diabetes); labor induction was guided using a standardized protocol. We evaluated the maternal and gestational age, parity, fetal tachysystole, hyper-stimulation, initial cervical status, time from induction to delivery, drug side effects, mode of delivery, and neonatal outcomes. Results: (a) The overall successful labor induction rate, evaluated by the vaginal delivery rate, was 71.6% (n=53), spontaneously or instrumentally assisted; 28.4% (n=21) births were unsuccessful MVI IOL, converted into caesareans. (b) No significant differences were found regarding the maternal outcomes; in terms of perinatal outcomes of safety, four cases of high-risk pregnancies vaginally delivered were associated with neonatal intensive care unit (NICU) admissions and a one-minute Apgar score under seven (5.4%). Most cases with adverse effects of misoprostol have been managed conservatively, except for three emergency C-section cases. Conclusions: Misoprostol vaginal insert is a safe choice in IOL in obese high-risk pregnancies with good maternal and perinatal outcomes.

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Section: Discussionmentioning

confidence: 99%

A New Approach in the Induction of Labor with Misoprostol Vaginal Insert in High-Risk Pregnancy Obese Women

Varlas¹,

Bostan²,

Ba³

et al. 2020

Preprint

View full text Add to dashboard Cite

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“…An MVI allows the release of misoprostol continuously for 24 h (approximately 7 μg/hour) while the insert remains in place, thus providing the correct dosing and reducing the incidence of adverse events. The reservoir is rapidly and easily removed if needed [ 15 , 22 ]. The induction of labor with an MVI in a study conducted by Rayburn et al revealed a 50% release of the drug by 12 h and 80% by 24 h [ 23 ].…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2021

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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.

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“…While several methods of cervical ripening before induction have been proposed, prostaglandins are the current agents of choice, as it has been shown that the rate of vaginal births increases within 24 h after labor induction and the need for oxytocin decreases [ 7 , 8 ]. As well as prostaglandins are effective for inducing cervical ripening and stimulating uterine contractions at various doses and routes of administration, orally or vaginally [ 8 , 9 ].…”

Section: Introductionmentioning

confidence: 99%

Labor induction with randomized comparison of cervical, oral and intravaginal misoprostol

Dadashaliha

Fallah

Mirzadeh

2021

BMC Pregnancy Childbirth

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Background This study attempts to evaluate the safety and effectiveness of 50μgm intracervical misoprostol in comparison with intravaginal and sublingual for the induction of labor at term pregnant women. Methods This study is designed as a parallel clinical trial study. Three hundred and fifteen term pregnancies requiring induction of labor were treated with the maximum used misoprostol intracervical, sublingual, and vaginal doses. Participants were randomly allocated into three groups of 105. The dose was repeated every 4 h until adequate uterine contraction and Bishop Score were achieved. The duration of induction to births, time to the active phase, the rate of births, and the need for caesarean section were compared in three groups. Additionally, labor course and side effects were recorded and analyzed. Data were analyzed using SPSS software. A significance level of p < 0.05 was considered for statistical analyses. Findings Labor was successfully induced in all cases most (63%) of which required a single dose of misoprostol. Ninety-three (93.0%, p < 0.05) cervical participants proceeded to vaginal births. This figure was also the same in the vaginal and sublingual group of 83 cases (83.0%). The other 41 cases received caesarean section with more indications of failure to progress and meconium-stained liquor. The results indicated that 278 (92.7%) births were achieved in less than 10 h. Time from start of medication to the active phase of labor and childbirth was 3.01 ± 0.86 and 6.1 ± 1.3 h in the Cervical group, 4.2 ± 0.66 and 8.4 ± 0.92 h in the sublingual group, and 5.06 ± 1.1 and 9.2 ± 1.5 h in the vaginal group respectively (p < 0.001). The Caesarean rate was lower in the cervical group than in the two other groups (p = 0.05). No significant differences were observed between the study groups in terms of Apgar score and meconium-stained amniotic fluid. Furthermore, no maternal and neonatal complications were observed. Conclusion In addition to the sublingual and intravaginal routes of administration, intracervical misoprostol at a single dose of 50μgm appears to be an effective method for induction of labor in women with an unfavorable cervix. Like all medical interventions, a discussion of the risks, benefits, and alternatives to induction of labor with this medication in each woman should be undertaken before treatment. Trial registration This clinical study was approved by the Iranian Registry of Clinical Trials with IRCT ID: IRCT20190415043278N1. Registration date was on May 13, 2019 and May 27, 2019 respectively (http://www.irct.ir).

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A critical appraisal of the misoprostol removable, controlled-release vaginal delivery system of labor induction

Cited by 7 publications

References 38 publications

A New Approach in the Induction of Labor with Misoprostol Vaginal Insert in High-Risk Pregnancy Obese Women

A New Approach in the Induction of Labor with Misoprostol Vaginal Insert in High-Risk Pregnancy Obese Women

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

Labor induction with randomized comparison of cervical, oral and intravaginal misoprostol

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