Dilapan-S®: A Multicenter US E-registry

NCT04451109 | Active Not Recruiting FDA Device

• 1 other identifier: Dilapan-S US E-registry
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

induction of labour; induction of labor; labour induction; labor induction; Dilapan; dilator; cervical ripening; cervical priming; preinduction; pre-induction

Outcome Measures

Primary Outcomes (1)

• Rate of overall vaginal delivery

  right after child delivery

Secondary Outcomes (7)

• 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

  48 hours

• Change in Bishop score

  48 hours

• Rate of spontaneous vaginal delivery

  right after child delivery

Study Arms (1)

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

Interventions

Dilapan-S DEVICE

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Selected patients fulfilling eligibility criteria.

You may qualify if:

• 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

You may not qualify if:

• Data not available for extraction

Sponsors & Collaborators

• Medicem Technology s.r.o.: lead
• The University of Texas Medical Branch, Galveston: collaborator

Study Sites (1)

The University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Related Publications (5)

• Martin JA, Hamilton BE, Osterman MJ, Driscoll AK, Mathews TJ. Births: Final Data for 2015. Natl Vital Stat Rep. 2017 Jan;66(1):1.

  PMID: 28135188 BACKGROUND

• 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.

  PMID: 30089070 BACKGROUND

• 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.

  PMID: 12368596 BACKGROUND

• 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.

  PMID: 30107363 BACKGROUND

• 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.

  PMID: 30790569 BACKGROUND

MeSH Terms

Conditions

Pregnancy, Prolonged; Fetal Membranes, Premature Rupture; Fetal Growth Retardation; Oligohydramnios; Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor Complications; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Antonio Saad, MD

  The University of Texas Medical Branch, Galveston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 30, 2020
• Study Start: December 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)