Comparison between vaginal and sublingual misoprostol 50 µg for cervical ripening prior to induction of labor: randomized clinical trial

Conde, Andrés; Ben, Sebastián; Tarigo, Josefina; Artucio, Santiago; Varela, Virginia; Grimaldi, Pamela; Sosa, Claudio; Alonso, Justo

doi:10.1007/s00404-017-4297-9

Cited by 3 publications

(3 citation statements)

References 19 publications

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“…This low frequency of meconium in the amniotic fluid may be a consequence of the low dose of medication used. The median first-and fifth-minute Apgar scores were the same in both groups and similar to those reported in a study conducted in Uruguay [26].…”

Section: Discussionsupporting

confidence: 87%

Misoprostol administered sublingually at a dose of 12.5 μg versus vaginally at a dose of 25 μg for the induction of full-term labor: a randomized controlled trial

et al. 2020

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Background: Labor induction is defined as any procedure that stimulates uterine contractions before labor begins spontaneously. The vaginal and oral routes of administration of misoprostol are those most used for the induction of labor in routine practice, with the recommended dose being 25 μg. Nevertheless, the sublingual route may reduce the number of vaginal examinations required, increasing patient comfort and lowering the risk of maternal and fetal infection. Based on a previous systematic review, the objective of this study was to compare the frequency of tachysystole as the main outcome measure when misoprostol is administered sublingually at the dose of 12.5 μg versus vaginally at a dose of 25 μg to induce labor in a full-term pregnancy with a live fetus. Methods: A randomized, placebo-controlled, triple-blind clinical trial was conducted at two maternity hospitals in northeastern Brazil. Two hundred patients with a full-term pregnancy, a live fetus, Bishop score ≤ 6 and an indication for induction of labor were included. Following randomization, one group received 12.5 μg misoprostol sublingually and a vaginal placebo, while the other group received a sublingual placebo and 25 μg misoprostol vaginally. The primary outcome was the frequency of tachysystole. Student's t-test, the chi-square test of association and Fisher's exact test were used, as appropriate. Risk ratios and their 95% confidence intervals were calculated. Results: The frequency of tachysystole was lower in the group using 12.5 μg misoprostol sublingually compared to the group using 25 μg misoprostol vaginally (RR = 0.15; 95%CI: 0.02-0.97; p = 0.002). Failure to achieve vaginal delivery within 12 and 24 h was similar in both groups. Sublingual administration was preferred to vaginal administration by women in both groups; however, the difference was not statistically significant. Conclusion: The effectiveness of labor induction with low-dose sublingual misoprostol was similar to that achieved with vaginal administration of the recommended dose; however, the rate of tachysystole was lower in the sublingual group, and this route of administration may prove a safe alternative.

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Section: Discussionsupporting

confidence: 87%

Misoprostol administered sublingually at a dose of 12.5 μg versus vaginally at a dose of 25 μg for the induction of full-term labor: a randomized controlled trial

et al. 2020

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“…However, a recent PROBAAT‐II multicenter Dutch study by Eikelder et al . and Uruguay study by Conde et al . used similar (50 μg) dose.…”

Section: Discussionmentioning

confidence: 99%

Premaquick^© versus modified Bishop score for preinduction cervical assessment at term: A double‐blind randomized trial

Eleje

Ezugwu

Ugwu

et al. 2018

J of Obstet and Gynaecol

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“…Of the 103 trials identified, just 63 were RCTs. 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 The majority of RCTs were single-center trials conducted in academic hospitals, which can limit the generalizability of the results to other community-based populations. Among the 12 multicenter trials, the number of centers ranged from 2 to 49 and tended to include both university-affiliated and community hospitals.…”

Section: Limitations Of Trials On Labor Inductionmentioning

confidence: 99%

Challenges and Limitations of Clinical Trials on Labor Induction: A Review of the Literature

Viteri

Sibai

2018

AJP Rep

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Induction of labor is a common obstetric procedure performed in nearly a quarter of all deliveries in the United States. Pharmacological (prostaglandins, oxytocin) and/or mechanical methods (balloon catheters) are commonly used for labor induction; however, there is ongoing debate as to which method is the safest and most effective. This narrative review discusses key limitations of published trials on labor induction, including the lack of well-designed randomized controlled trials directly comparing specific methods of induction, heterogeneous trial populations, and wide variation in the protocols used and outcomes reported. Furthermore, the majority of published trials were underpowered to detect significant differences in the most clinically relevant efficacy and safety outcomes (e.g., cesarean delivery, neonatal mortality). By identifying the limitations of labor induction trials, we hope to highlight the importance of quality published data to better inform guidelines and drive evidence-based treatment decisions.

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Comparison between vaginal and sublingual misoprostol 50 µg for cervical ripening prior to induction of labor: randomized clinical trial

Abstract: NCT02732522. Registry website: https://clinicaltrials.gov/ .

Cited by 3 publications

References 19 publications

Misoprostol administered sublingually at a dose of 12.5 μg versus vaginally at a dose of 25 μg for the induction of full-term labor: a randomized controlled trial

Misoprostol administered sublingually at a dose of 12.5 μg versus vaginally at a dose of 25 μg for the induction of full-term labor: a randomized controlled trial

Premaquick^© versus modified Bishop score for preinduction cervical assessment at term: A double‐blind randomized trial

Challenges and Limitations of Clinical Trials on Labor Induction: A Review of the Literature

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Comparison between vaginal and sublingual misoprostol 50 µg for cervical ripening prior to induction of labor: randomized clinical trial

Abstract: NCT02732522. Registry website: https://clinicaltrials.gov/ .

Cited by 3 publications

References 19 publications

Misoprostol administered sublingually at a dose of 12.5 μg versus vaginally at a dose of 25 μg for the induction of full-term labor: a randomized controlled trial

Misoprostol administered sublingually at a dose of 12.5 μg versus vaginally at a dose of 25 μg for the induction of full-term labor: a randomized controlled trial

Premaquick© versus modified Bishop score for preinduction cervical assessment at term: A double‐blind randomized trial

Challenges and Limitations of Clinical Trials on Labor Induction: A Review of the Literature

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Product

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Premaquick^© versus modified Bishop score for preinduction cervical assessment at term: A double‐blind randomized trial