Dilapan-S®: A Multicenter US E-registry

Medicem Technology s.r.o.

Status: Active, not recruiting

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

Treatments: Device: Dilapan-S

Study type: Observational

Funder types: Other

Identifiers

NCT04451109

Dilapan-S US E-registry

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant woman whose plan of care is induction of labor
• Maternal age ≥ 18 years
• Gestational age ≥ 37 +0/7 weeks
• Dilapan-S® used for cervical ripening

Exclusion criteria

• Data not available for extraction

Trial design

1,200 participants in 1 patient group

Cases in which Dilapan-S was used for cervical ripening.

Description:

Every participating site will select 50 cases of pregnant women who underwent cervical ripening by Dilapan-S prior to induction of labor. These cases has to fulfill inclusion/exclusion criteria defined in the protocol.

Treatment:

Device: Dilapan-S