Dilapan-S®: A Multicenter US E-registry

Active, not recruiting

• Conditions: Gestational Diabetes; Fetal Growth Retardation; High Blood Pressure in Pregnancy; Post Term Pregnancy; Premature Rupture of Membrane; Oligohydramnios
• Interventions: Device: Dilapan-S

• Registration Number: NCT04451109
• Lead Sponsor: Medicem Technology s.r.o.

Brief 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.

Study Timeline

• Study First Submitted: 2020-06-17
• Study First Submitted QC: 2020-06-25
• Study First Posted: 2020-06-30
• Study Start: 2020-12-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 1200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Rate of overall vaginal delivery	right after child delivery

Secondary Outcome Measures

Name	Time	Method
Rate of vaginal delivery within 24 hours	24 hours
Rate of caesarean sections	right after child delivery
Time to reach active stage of labor defined as ≥6 cm	48 hours	minutes
Rate of vaginal delivery within 36 hours	36 hours
Rate of spontaneous vaginal delivery	right after child delivery
Rate of operative vaginal delivery	right after child delivery
Change in Bishop score	48 hours	scale 0-13 (positive gain in Bishop score is considered to be a positive consequence of the intervention)

Trial Locations

Locations (1)

The University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States