Dilapan-S®: A Multicenter US E-registry

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Oligohydramnios; Fetal Growth Retardation; Gestational Diabetes; Post Term Pregnancy; Premature Rupture of Membrane; High Blood Pressure in Pregnancy
• Intervention / Treatment: Device: Dilapan-S

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 Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • The University of Texas Medical Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Selected patients fulfilling eligibility criteria.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases in which Dilapan-S was used for cervical ripening.; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of overall vaginal delivery	right after child delivery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medicem Technology s.r.o.
• Collaborators: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Antonio Saad, MD, The University of Texas Medical Branch, Galveston

Publications and helpful links

General Publications

• Martin JA, Hamilton BE, Osterman MJ, Driscoll AK, Mathews TJ. Births: Final Data for 2015. Natl Vital Stat Rep. 2017 Jan;66(1):1.
• Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. N Engl J Med. 2018 Aug 9;379(6):513-523. doi: 10.1056/NEJMoa1800566.
• Rayburn WF. Preinduction cervical ripening: basis and methods of current practice. Obstet Gynecol Surv. 2002 Oct;57(10):683-92. doi: 10.1097/00006254-200210000-00022.
• Gupta J, Chodankar R, Baev O, Bahlmann F, Brega E, Gala A, Hellmeyer L, Hruban L, Maier J, Mehta P, Murthy A, Ritter M, Saad A, Shmakov R, Suneja A, Zahumensky J, Gdovinova D. Synthetic osmotic dilators in the induction of labour-An international multicentre observational study. Eur J Obstet Gynecol Reprod Biol. 2018 Oct;229:70-75. doi: 10.1016/j.ejogrb.2018.08.004. Epub 2018 Aug 3.
• Saad AF, Villarreal J, Eid J, Spencer N, Ellis V, Hankins GD, Saade GR. A randomized controlled trial of Dilapan-S vs Foley balloon for preinduction cervical ripening (DILAFOL trial). Am J Obstet Gynecol. 2019 Mar;220(3):275.e1-275.e9. doi: 10.1016/j.ajog.2019.01.008. Epub 2019 Feb 18.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): November 23, 2022
• Last Update Submitted That Met QC Criteria: November 22, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: induction of labour; cervical ripening; labor induction; induction of labor; labour induction; Dilapan; dilator; cervical priming; preinduction; pre-induction
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Wounds and Injuries; Endocrine System Diseases; Diabetes Mellitus; Fetal Diseases; Pregnancy Complications; Obstetric Labor Complications; Growth Disorders; Hypertension; Rupture; Oligohydramnios; Pregnancy, Prolonged; Fetal Growth Retardation; Diabetes, Gestational; Fetal Membranes, Premature Rupture
• Other Study ID Numbers: Dilapan-S US E-registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No