Cervical ripening after cesarean section: a prospective dual center study comparing a mechanical osmotic dilator vs. prostaglandin E2

Koenigbauer, Josefine Theresia; Schalinski, E; Jarchau, U; Gauger, Ulrich; Brandt, Katrin; Klaucke, Sandra; Scharf, JP; Rath, Werner; Hellmeyer, L

doi:10.1515/jpm-2021-0157

Cited by 10 publications

(13 citation statements)

References 37 publications

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“…It is surprising that according to our recent PubMed search there are only two prospective observational studies on cervical ripening using the Dilapan-S in women with previous Caesarean delivery. Both studies are from the same working group 24 25 and it is not yet possible to make definite evidence-based recommendations based solely on these studies.…”

Section: Discussionmentioning

confidence: 99%

“… Osmotischer Zervixdilatator vs. vaginales PGE 2 zur Zervixreifung nach Sectio (Daten aus 25 ). BS = Bishop Score …”

Section: Hygroskopische Zervixdilatatoren (Dilapan-s) Zur Zervixreifu...unclassified

“…In contrast to the extensive data on balloon catheters, a recent PubMed search showed that data on hygroscopic cervical dilators is extremely limited. An initial study by our working group published in 2017 24 was continued 25 ; as far as we know, this is the only study to investigate the use of the Dilapan-S dilator in women after previous Caesarean delivery.…”

Section: Hygroscopic Cervical Dilator (Dilapan-s) For Cervical Ripeni...mentioning

confidence: 99%

“…Foley catheters have not been generally approved for cervical ripening/induction of labour; double-balloon catheters have been approved, however, their use is contraindicated for labour induction in women with a previous Caesarean section when considering product informations. Cervical ripening with the Dilapan-S dilator is not contraindicated after previous Caesarean section, however, according to our recent PubMed search there are only 2 prospective studies on this issue conducted by the same working group 24 25 .…”

Section: Introductionmentioning

confidence: 99%

“…Der Foley-Katheter ist zur Zervixreifung/Geburtseinleitung generell nicht zugelassen, der Doppelballonkatheter ist zugelassen, laut Produktinformation aber zur Geburtseinleitung nach Sectio kontraindiziert. Nach Sectio ist die Zervixreifung mit dem Dilapan-S erlaubt, mit dem allerdings ausweislich einer aktuellen PubMed-Recherche nur 2 prospektive Studien der gleichen Arbeitsgruppe vorliegen 24 25 .…”

Section: Introductionunclassified

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Mechanical Methods for the Induction of Labour After Previous Caesarean Section – An Updated, Evidence-based Review

Rath

Hellmeyer

Tsikouras

et al. 2022

Geburtshilfe Frauenheilkd

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There are currently no up-to-date evidence-based recommendations on the preferred method to induce labour after previous Caesarean section, especially for patients with unripe cervix, as randomised controlled studies are lacking. Intravenous oxytocin and misoprostol are contraindicated in these women because of the high risk of uterine rupture. In women with ripe cervix (Bishop Score > 6), intravenous administration of oxytocin is an effective procedure with comparable rates of uterine rupture to those with spontaneous onset of labour. Vaginal prostaglandin E2 (PGE2) and mechanical methods (balloon catheters, hygroscopic cervical dilators) are effective methods to induce labour in pregnant women with unripe cervix and previous Caesarean section. According to current guidelines, the administration of PGE2 is associated with a higher rate of uterine rupture compared to balloon catheters. Balloon catheters are therefore a suitable alternative to PGE2 to induce labour after previous Caesarean section, even though this is an off-label use. In addition to two meta-analyses published in 2016, 12 mostly retrospective cohort/observational studies with low to moderate levels of evidence have been published on mechanical methods of cervical ripening after previous Caesarean section. But because of the significant heterogeneity of the studies, substantial differences in study design, and insufficient numbers of pregnant women included in the studies, it is not possible to make any evidence-based recommendations based on these studies. According to a recent meta-analysis, the average rate using balloon catheters is approximately 53% and the average rate after spontaneous onset of labour is 72%. The uterine rupture rate was 0.2–0.9% for vaginal PGE2 and 0.56–0.94% for balloon catheters and is therefore comparable to the uterine rupture rate associated with spontaneous onset of labour. According to the product informations, hygroscopic cervical dilators (Dilapan-S) are currently the only method which is not contraindicated for cervical ripening/induction of labour in women with previous Caesarean section, although data are insufficient. Well-designed, randomised, controlled studies with sufficient case numbers comparing balloon catheters and hygroscopic cervical dilators with mechanical methods and vaginal prostaglandin E2/oral misoprostol are therefore necessary to allow proper decision-making.

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Section: Discussionmentioning

confidence: 99%

“… Osmotischer Zervixdilatator vs. vaginales PGE 2 zur Zervixreifung nach Sectio (Daten aus 25 ). BS = Bishop Score …”

Section: Hygroskopische Zervixdilatatoren (Dilapan-s) Zur Zervixreifu...unclassified

Section: Hygroscopic Cervical Dilator (Dilapan-s) For Cervical Ripeni...mentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionunclassified

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Mechanical Methods for the Induction of Labour After Previous Caesarean Section – An Updated, Evidence-based Review

Rath

Hellmeyer

Tsikouras

et al. 2022

Geburtshilfe Frauenheilkd

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Synthetic Osmotic Dilators for Pre-Induction Cervical Ripening – an Evidence-Based Review

Rath

Kummer

Königbauer

et al. 2023

Geburtshilfe Frauenheilkd

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Mechanical methods have gained growing interest for pre-induction cervical ripening in women with an unripe cervix, since they have a better safety profile compared to prostaglandins. Balloon catheters have been the gold standard method for decades, while there was a lack of data on synthetic osmotic cervical dilators.Not until 2015, when Dilapan-S was approved by the Food and Drug Administration (FDA) for induction of labor, numerous studies have been published on the use of Dilapan-S in this field. The rate of vaginal deliveries associated with the use of Dilapan-S ranges from 61.6 to 81.7%, and no serious complications needing further interventions have been reported to this date.Dilapan-S was shown to be as effective as the Foley balloon catheter as well as the 10 mg PGE2 vaginal insert and orally applied misoprostol (25 µg every 2 hours) in achieving vaginal delivery, but patient’s satisfaction during the cervical ripening process was significantly higher compared to the other methods and the rate of uterine hyperstimulation was significantly lower compared to prostaglandins (PGs).Minor complications (e.g. vaginal bleeding) associated with the use of Dilapan-S were < 2%, and maternal infectious morbidity was not higher compared to Foley balloon and vaginal PGE2 or misoprostol.Due to these beneficial properties Dilapan-S might be an ideal option for outpatient cervical ripening, as shown in a recent randomized clinical trial comparing inpatient to outpatient cervical ripening.Furthermore, according to the manufacturers’ product information, Dilapan-S is the only cervical ripening method that is not contraindicated for induction of labor in women with a previous cesarean section. Upcoming guidelines should consider synthetic osmotic cervical dilators as an effective and safe method for cervical ripening/induction of labor acknowledging that more evidence-based data are mandatory, particularly in patients with a previous cesarean section.

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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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Cervical ripening after cesarean section: a prospective dual center study comparing a mechanical osmotic dilator vs. prostaglandin E2

Cited by 10 publications

References 37 publications

Mechanical Methods for the Induction of Labour After Previous Caesarean Section – An Updated, Evidence-based Review

Mechanical Methods for the Induction of Labour After Previous Caesarean Section – An Updated, Evidence-based Review

Synthetic Osmotic Dilators for Pre-Induction Cervical Ripening – an Evidence-Based Review

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

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