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

Abstract

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.

Retracted Dilapan-s in a multiparous woman at term on induction of labour

“…Very few cases of osmotic cervical dilators have been reported and relates to the previous version of DIlapan 5 . In two of such cases reported in the literature, both were related to cervical ripening for termination of pregnancy 7,8 .…”

“…It is an effective means of induction of labour with a very good safety profile and no known associated foetal complications due to its unlikely chance of causing uterine hyperstimulation 2,4,5 . Many large studies have found no cases of uterine tachysystole related to Dilapan-S use during cervical ripening and it is increasingly been used as an agent for outpatient induction of labour.…”

“…However, known complications of its use include, bleeding, mild discomfort, falling out of the cervix and the vagina, spontaneous rupture of membrane, cervical tear, breaking of the rod during retrieval, sticking of the rod to the vagina or the cervix and rarely, retraction into the uterus 4 . Retracted Dilapan-S is very rare 5 .…”