NCT04451109

Dilapan-S®: A Multicenter US E-registry

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,200 (estimated)
• Sponsor: Medicem Technology s.r.o. · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Objective of this registry is to collect a representative set of real world data on the use of Dilapan-S® for pre-induction cervical ripening in daily clinical practice. Upon completion of the registry, relevant collected data will be analyzed and published.

Detailed description

In the US, 23% of pregnant women undergo labor induction. A recent randomized controlled trial showed that elective labor induction at term in low-risk nulliparous women is associated with a lower risk of cesarean delivery and preeclampsia, with no increase in adverse perinatal morbidities. Hence, one can assume that labor induction rates will increase. The majority of women undergoing induction have unfavorable cervixes and require cervical ripening agents. Dilapan-S®, a hygroscopic cervical dilator made from a patented hydrogel (AQUACRYL), has been used in the past for cervical ripening for early gestation uterine evacuation. Dilapan-S® was approved by the FDA for cervical ripening in the third trimester in 2015. The Dilapan-S® rods are inserted into the cervical canal, are contained within the vagina, and do not require tension. Dilapan-S® works by absorbing fluid from cervical canal cells, resulting in reversible cell membrane dehydration and softening. In addition, the increase in the rod's volume creates a mechanical stretch and leads to the release of endogenous prostaglandins, causing cervical ripening. Recently, a multicenter prospective cohort study showed that Dilapan-S® is a safe and effective method for cervical ripening in term gestations. Lastly, our group performed non-inferiority randomized clinical trial comparing Dilapan-S® to Foley balloon for cervical ripening in term pregnancies and found that Dilapan-S® is non-inferior to Foley balloon for pre-induction cervical ripening at term. The Dilapan-S® rods are inserted into the cervical canal, are contained within the vagina, and do not require tension. Dilapan-S® works by absorbing fluid from cervical canal cells, resulting in reversible cell membrane dehydration and softening. In addition, the increase in the rod's volume creates a mechanical stretch and leads to the release of endogenous prostaglandins, causing cervical ripening. Advantages of Dilapan-S® over Foley include FDA approval, safe profile, no protrusion from the introitus, no need to keep under tension and better patient satisfaction.

Conditions

• Post Term Pregnancy
• Premature Rupture of Membrane
• Fetal Growth Retardation
• Oligohydramnios
• Gestational Diabetes
• High Blood Pressure in Pregnancy

Interventions

Type	Name	Description
DEVICE	Dilapan-S	Application of Dilapan-S and all other procedures regarding cervical ripening and induction of labor will be carried out as per the hospital's standard practice.

Timeline

• Start date: 2020-12-01
• Primary completion: 2024-12-31
• Completion: 2025-06-30
• First posted: 2020-06-30
• Last updated: 2024-11-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study