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Declined by SafariScribe 46 hours ago. Last edited by Abominate 0 seconds ago. Reviewer: Inform author.

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Dilapan-S

Dilapan-S is a synthetic osmotic cervical dilator produced by the Czech medical company Medicem for use in obstetrics and gynaecology. It is used in medical procedures requiring cervical ripening or cervical dilation. Dilapan-S is designed to gradually and gently expand the cervical canal, facilitating procedures such as labour induction.

Background

Dilapan-S offers a non-pharmacological, mechanical option for cervical ripening and dilation, making it a widely used alternative to drug-based methods.

Dilapan-S is made of Aquacryl®, a biocompatible hydrogel material that gradually expands as it absorbs moisture, applying gentle pressure to the cervix. This controlled, non-hormonal method of dilation has gained popularity as a reliable alternative for patients sensitive to medications or hormonal agents. First introduced in Europe, Dilapan-S has since become available in countries worldwide, recognised for its effectiveness, comfort and low risk of side effects. The device is available in different sizes depending on the patient's clinical needs.

Medical use

Dilapan-S is indicated for use in cases where cervical ripening or dilation is desired, providing a non-pharmacological option for preparing the cervix for gynaecological and obstetric procedures, including labour induction. Inserted into the cervix, the device gradually expands over several hours, opening the cervical canal while stimulating the natural production of prostaglandins. This helps soften and ripen the cervix, making it ready for delivery or other interventions.

Recognised for providing controlled, predictable dilation, Dilapan-S has been associated with fewer complications compared to pharmacological alternatives. Its non-pharmacological approach also makes it suitable for patients who may not be candidates for pharmacological methods, offering a mechanical means of cervical ripening without systemic side effects.

Mode of action

Dilapan-S has three modes of action—biophysical, mechanical, and physiological mechanisms:

Biophysical action: Dilapan-S dilators are hygroscopic, meaning they absorb moisture from the surrounding cervical tissue. This absorption creates a reversible osmotic dehydration effect in the cervix, leading to the softening and change in consistency of the tissue.
Mechanical action: As the dilators expand, they exert gentle, radial pressure on the cervical walls. This pressure initiates a controlled, predictable dilation of the cervix.
Physiological action: The applied pressure triggers the breakdown of collagen within cervical tissue and promotes the release of endogenous prostaglandins (body own hormones). These natural compounds further make the cervix soft and stretchy, preparing it for labour.

By combining these mechanisms, Dilapan-S achieves cervical ripening without pharmacological agents, minimising the risks of uterine hyperstimulation and side effects associated with hormonal methods.

Process of induction of labour (IOL) with Dilapan-S

The induction of labour with Dilapan-S involves the insertion of multiple dilators into the cervical canal, typically for a period of 12 to 24 hours. These dilators support cervical ripening, which may be followed by procedures such as artificial rupture of membranes or the administration of oxytocin to induce contractions. Due to its gentle mechanical action, Dilapan-S is often regarded as a reliable option for pre-induction cervical ripening in patients requiring labour induction for medical reasons, such as prolonged pregnancies.

Technology and Development

Dilapan-S is produced by the Czech medical technology company Medicem, leveraging its patented material platform featuring a unique hydrogel designed to offer gradual, controlled expansion under pressure. Researchers working for the company have been involved in the development of cervical ripening technologies since the 1980s, refining the use of osmotic dilators over several decades.

The device is single-use and meets international healthcare safety standards, including those established by ISO certification bodies. The hydrogel material used in Dilapan-S allows it to function effectively while maintaining a strong safety profile.

Clinical Research and Guidelines

Dilapan-S has been the subject of multiple clinical trials and research studies, many of which have supported its use as an effective method for cervical ripening with positive patient outcomes. In particular, studies have shown that it has comparable or superior outcomes to pharmacological agents and other mechanical methods, with fewer side effects such as uterine hyperstimulation or foetal distress. Additionally, in all studies conducted, Dilapan-S was found to be superior in terms of patient satisfaction when compared to various competing methods, likely due to its gentle, non-pharmacological approach and lower incidence of discomfort.

Key clinical trials include:

Walker KF et al. Synthetic osmotic dilators (DILAPAN-S) or dinoprostone vaginal insert (Propess) for inpatient induction of labour: A UK cost-consequence model. Eur J Obstet Gynecol Reprod Biol.: Nov 2022

The cost-consequence model found that Dilapan-S reduced midwife time by 147 minutes per patient compared to dinoprostone, making it a cost-effective alternative.

https://www.ejog.org/article/S0301-2115(22)00483-3/fulltext

Saad AF et al. Outpatient Compared With Inpatient Preinduction Cervical Ripening Using a Synthetic Osmotic Dilator: A Randomized Clinical Trial, Obstetrics & Gynecology: Oct 2022

The HOMECARE trial showed that outpatient use of Dilapan-S reduced hospital stay, analgesia use, and improved maternal satisfaction compared to inpatient procedures.

https://journals.lww.com/greenjournal/fulltext/2022/10000/outpatient_compared_with_inpatient_preinduction.8.aspx

Gupta JK et al. A randomized trial of synthetic osmotic cervical dilator for induction of labor vs dinoprostone vaginal insert (SOLVE trial), AJOG: July 2022

A prospective randomised trial compared Dilapan-S to dinoprostone vaginal insert. The trial demonstrated that Dilapan-S had similar vaginal delivery rate, while offering significant decrease in analgesia need, fewer complications and greater maternal satisfaction compared to dinoprostone for labour induction.

https://www.ajogmfm.org/article/S2589-9333(22)00070-2/fulltext#relatedArticles

Gavara R et al. Cervical Ripening Efficacy of Synthetic Osmotic Cervical Dilator Compared With Oral Misoprostol at Term (COMRED trial), Obstetrics & Gynecology: May 2022

A prospective, multicentre randomised clinical trial compared Dilapan-S to low-dose oral misoprostol (25 mcg) for cervical ripening. The study found that Dilapan-S is fully comparable to misoprostol in vaginal delivery rates while offering a better safety profile and superior maternal satisfaction.

https://journals.lww.com/greenjournal/abstract/2022/06000/cervical_ripening_efficacy_of_synthetic_osmotic.14.aspx

Saad AF et al. A randomized controlled trial of DILAPAN-S vs Foley balloon for preinduction cervical ripening (DILAFOL trial), Am J Obstet Gynecol: March 2019

A prospective, randomised controlled trial comparing Dilapan-S to the Foley balloon found that Dilapan-S resulted in higher maternal satisfaction and lower caesarean section rates.

https://www.ajog.org/article/S0002-9378(19)30036-5/fulltext

Further information

Baev O et al. Combined use of Dilapan-S and mifepristone for labour induction in nulliparous women. European Journal of Obstetrics and Gynecology and Reproductive Biology, Volume 234, e96 - e97
Crosby D.A. et al. A prospective pilot study of Dilapan-S compared with Propess for induction of labour at 41+ weeks in nulliparous pregnancy. Ir J Med Sci 187, 693–699 (2018). https://doi.org/10.1007/s11845-017-1731-8
Elders M et al. Dilapan-S versus vaginal misoprostol for cervical preparation before diagnostic hysteroscopy: a prospective randomized controlled trial. Online. Italian Journal of Gynaecology and Obstetrics. 2024, ISSN 23850868.

Leela K et al. Efficacy of Dilapan S compared to foley balloon in preinduction cervical ripening—a noninferiority trial: AJOG Global Reports: November 2024

Shahriyaripour R et al. Cervical Preparation for Hysteroscopy Using Dilapan-S Three Hours before Surgery: A Randomized Controlled Trial. Clin. Exp. Obstet. Gynecol. 2024, 51(1), 9. https://doi.org/10.31083/j.ceog5101009

References

Inducing labour: NICE guideline [NG207], Nov 2021.
Rath W et al. Synthetic Osmotic Dilators for Pre-Induction Cervical Ripening – an Evidence-Based Review, Geburtshilfe und Frauenheilkunde: July 2023
Gupta J. et al. A randomized trial of synthetic osmotic cervical dilator for induction of labor versus dinoprostone vaginal insert (SOLVE), AJOG, March 2022
Saad AF et al. Outpatient Compared With Inpatient Preinduction Cervical Ripening Using a Synthetic Osmotic Dilator: A Randomized Clinical Trial, Obstetrics & Gynecology: Oct 2022
Gavara R. et al. Cervical Ripening Efficacy of Synthetic Osmotic Cervical Dilator Compared With Oral Misoprostol at Term, Obstetrics & Gynecology: May, 2022
Walker K et al. The mechanical dilator (Dilapan-S) for inpatient cervical ripening: A UK economic model, Eur J Obstet Gynecol Reprod Biol.: Nov 2022
Saad A. et al. A randomized controlled trial of DILAPAN-S vs Foley balloon for preinduction cervical ripening (DILAFOL trial), Am J Obstet Gynecol 220(3), March 2019