Cervical Ripening Efficacy of Synthetic Osmotic Cervical Dilator Compared With Oral Misoprostol at Term

Gavara, Rachana; Saad, Antonio F.; Wapner, Ronald J.; Saade, George R.; Fu, Anne; Barrow, Ruth; Nalgonda, Swapna; Bousleiman, Sabine; Almonte, Cassandra; Alnafisee, Sarah; Holman, Anita; Burgansky, Anna; Heikkila, Pekka

doi:10.1097/aog.0000000000004799

Cited by 12 publications

(17 citation statements)

References 22 publications

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“…There are at least three randomized trials regarding inpatient cervical ripening using this synthetic osmotic dilator for term pregnancies. 15 , 20 , 21 Saad et al 15 compared this synthetic osmotic dilator to the Foley balloon. The former was noninferior to the Foley method regarding safety and efficacy with better patient satisfaction.…”

Section: Discussionmentioning

confidence: 99%

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Outpatient Compared With Inpatient Preinduction Cervical Ripening Using a Synthetic Osmotic Dilator

Saad

Gavara

Senguttuvan

et al. 2022

Obstetrics &Amp; Gynecology

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Section: Discussionmentioning

confidence: 99%

“…The former was noninferior to the Foley method regarding safety and efficacy with better patient satisfaction. Gavara et al 20 compared this synthetic osmotic dilator to low-dose oral misoprostol. They found that the dilator was noninferior regarding vaginal delivery within 36 hours, with better patient satisfaction.…”

Section: Discussionmentioning

confidence: 99%

Outpatient Compared With Inpatient Preinduction Cervical Ripening Using a Synthetic Osmotic Dilator

Saad

Gavara

Senguttuvan

et al. 2022

Obstetrics &Amp; Gynecology

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“…37,38 Both RCTs showed that dilapan-S was not clinically inferior to misoprostol. 37,38 Moreover, dilapan-S correlated with higher patient satisfaction and better quality of life in terms of enhanced sleep and lower pain scores compared with misoprostol. 37 Additionally, the rates of adverse events (e.g., uterine tachysystole) trended to be higher in disfavor of the misoprostol group compared with the dilapan-S group.…”

Section: Interpretation Of Findings and Clinical Implicationsmentioning

confidence: 99%

Cervical Osmotic Dilators versus Dinoprostone for Cervical Ripening during Labor Induction: A Systematic Review and Meta-analysis of 14 Controlled Trials

et al. 2023

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Objective This study aimed to conduct a systematic review and meta-analysis of all randomized and nonrandomized controlled trials (RCTs and NCTs, respectively) that explored the maternal–neonatal outcomes of cervical osmotic dilators versus dinoprostone in promoting cervical ripening during labor induction. Study Design Six major databases were screened until August 27, 2022. The quality of included studies was evaluated. The data were summarized as mean difference or risk ratio (RR) with 95% confidence interval (CI) in a random-effects model. Results Overall, 14 studies with 15 arms were analyzed (n = 2,380 patients). Ten and four studies were RCTs and NCTs, respectively. The overall quality for RCTs varied (low risk n = 2, unclear risk n = 7, and high risk n = 1), whereas all NCTs had good quality (n = 4). For the primary endpoints, there was no significant difference between both groups regarding the rate of normal vaginal delivery (RR = 1.04, 95% CI: 0.95–1.14, p = 0.41) and rate of cesarean delivery (RR = 1.04, 95% CI: 0.93–1.17, p = 0.51). Additionally, there was no significant difference between both groups regarding the mean change in Bishop score and mean time from intervention to delivery. The rate of uterine hyperstimulation was significantly lower in the cervical osmotic dilator group. For the neonatal outcomes, during cervical ripening, the rate of fetal distress was significantly lower in the cervical osmotic dilator group. There was no significant difference between both groups regarding the mean Apgar scores, rate of meconium-stained amniotic fluid, rate of umbilical cord metabolic acidosis, rate of neonatal infection, and rate of neonatal intensive care unit admission. Conclusion During labor induction, cervical ripening with cervical osmotic dilators and dinoprostone had comparable maternal–neonatal outcomes. Cervical osmotic dilators had low risk of uterine hyperstimulation compared with dinoprostone. Overall, cervical osmotic dilators might be more preferred over dinoprostone in view of their analogous cervical ripening effects, comparable maternal–neonatal outcomes, and lack of drug-related adverse events. Key Points

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“…Seit der Zulassung von Dilapan-S 2015 zur Zervixreifung im dritten Trimenon haben zahlreiche klinische Studien und RCTs bestätigt, dass Dilapan-S eine sichere, wirksame und kosteneffiziente Methode zur Zervixreifung/Geburtseinleitung darstellt, die mit hoher maternaler Zufriedenheit verbunden ist [14,16,17]. Je nach Definition der Outcome-Kriterien liegt die Rate der vaginalen Geburten nach Dilapan-S zwischen 61,6 und 81,3 % [16,17].…”

Section: Wirksamkeit Und Sicherheitunclassified

“…Die identifizierten RCTs zeigen, dass die Anwendung von Dilapan-S genauso effektiv zu einer Vaginalgeburt führt wie PGE 2 bzw. Misoprostol, dabei seltener mit Komplikationen assoziiert ist als PGE 2 und Misoprostol und die maternale Zufriedenheit größer ist [16,17].…”

Section: Wirksamkeit Und Sicherheitunclassified

Synthetische osmotische Dilatatoren zur Zervixreifung vor Geburtseinleitung

Rath,

Kummer,

Königbauer

et al. 2024

Hebamme

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In den vergangenen 20 Jahren hat sich der Anteil der eingeleiteten Geburten in Ländern mit hohem Durchschnittseinkommen nahezu verdoppelt. In Deutschland lag er 2020 bei 21,8% 1. Geburtseinleitungen bei unreifer Zervix sind mit längerer Behandlungsdauer, höheren Kosten, schmerzhafteren Wehen und geringerer Akzeptanz der Schwangeren verbunden 2. Aufgrund kontraktionsbedingter uteriner Hypoperfusion ist der Stress für die feto-plazentare Einheit erhöht, was bei verminderter fetaler Reserve zu fetalem Distress führen kann. Damit ist das Interesse an mechanischen Methoden (Ballonkatheter, synthetische osmotische Dilatatoren) zur Zervixreifung vor Einleitung gestiegen 3. Der Artikel zeigt anhand 2015-2022 veröffentlichter Studien über die Anwendung von Dilapan-S zur Zervixreifung bzw. Geburtseinleitung – evidenzbasierte Empfehlungen für die klinische Praxis auf.

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Cervical Ripening Efficacy of Synthetic Osmotic Cervical Dilator Compared With Oral Misoprostol at Term

Abstract: A synthetic osmotic cervical dilator is noninferior to oral misoprostol for cervical ripening at term, and its advantages include a better safety profile, less tachysystole, U.S. Food and Drug Administration approval, and better patient satisfaction.

Cited by 12 publications

References 22 publications

Outpatient Compared With Inpatient Preinduction Cervical Ripening Using a Synthetic Osmotic Dilator

Outpatient Compared With Inpatient Preinduction Cervical Ripening Using a Synthetic Osmotic Dilator

Cervical Osmotic Dilators versus Dinoprostone for Cervical Ripening during Labor Induction: A Systematic Review and Meta-analysis of 14 Controlled Trials

Synthetische osmotische Dilatatoren zur Zervixreifung vor Geburtseinleitung

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