Ultrasound Assessment of DILAPAN-S (USE-Dilapan)

August 7, 2023 updated by: Elizabeth Seagraves, Eastern Virginia Medical School

Longitudinal Ultrasound Evaluation of Dilapan-S During Cervical Ripening

The goal of this observational prospective study is to assess the change in Dilapan-S rod diameters using transvaginal ultrasound over a period of 12 hours in term women undergoing induction of labor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

On admission for induction, study participants assigned to each group underwent continuous cardiotocography for 20 minutes prior to placement of the Dilapan-S rods (rod size: 4 x 65mm). Placement of the Dilapan-S rods was limited to three physicians with the majority placed by the primary investigator. Placement was completed in a sterile manner under direct visualization and in accordance with the manufacturer's guidelines. The number of rods placed varied per individual and was based on the discretion of the physician. Each participant allocated to the Dilapan-S with saturated gauze group received placement of one, 4x4 inch gauze saturated with 10 cc of normal saline and placed at the level of the external os. Immediately after placement of the Dilapan-S rods, the study participant was asked to complete a patient satisfaction survey.

Pre-specified transvaginal ultrasound assessment was performed at hours 3, 6, 8, and 12 post Dilapan-S placement using a GE Voluson E10 machine with a transvaginal GE RIC 5-9D transducer. Performance of the ultrasound evaluation was limited to the primary investigator and two co-authors of the study. After completion of the 12-hour ultrasound, the Dilapan-S rods and gauze, if used, were removed as per the manufacturer's instructions. The participant was then asked to complete a post Dilapan-S patient satisfaction survey.

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Norfolk, Virginia, United States, 23501
        • Eastern Virginia Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Pregnant individuals at term undergoing labor induction at single academic institution.

Description

Inclusion Criteria:

  • Pregnant individuals at gestational age 37 weeks or greater.
  • Scheduled medical or elective induction at Sentara Norfolk General Hospital.
  • Live, singleton IUP.
  • Vertex presentation.
  • Intact membranes.
  • Bishop score of 6 or less.

Exclusion Criteria:

  • Unwilling or unable to provide consent.
  • Intrauterine fetal demise
  • Contraindications to vaginal delivery.
  • BMI > 45
  • Vaginal bleeding
  • Clinically evident genital tract infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant individuals with Dilapan-S only
22 women received Dilapan-S rods without gauze at start of induction.
Other: No gauze
no gauze
Pregnant individuals with Dilapan-S plus gauze placement
22 women received Dilapan-S rods with 1 gauze at start of induction.
Other: Gauze
placement of gauze

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diameter change of Dilapan-S
Time Frame: 12 hours
Rod diameters of Dilapan-S rods were measured via transvaginal ultrasound at 3,6,8, and 12 hours after placement.
12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gauze placement and rod diameter
Time Frame: 12 hours
Rod diameters of Dilapan-S rods plus gauze placement were measured via transvaginal ultrasound at 3,6,8, and 12 hours after placement.
12 hours
Patient satisfaction
Time Frame: 12 hours
Patient satisfaction scores were assessed based on gauze versus no gauze placement.
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Virginia Medical School

Collaborators

Medicem International CR s.r.o.

Investigators

  • Principal Investigator: Elizabeth Seagraves, DO, Eastern Virginia Medical School MFM Fellowship

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

August 17, 2020

First Submitted That Met QC Criteria

August 24, 2020

First Posted (Actual)

August 28, 2020

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-40-FB-0097

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocol, statistical analysis plan, informed consent form were made available. Results from the study will be available to the manufacturer (Medicem) after statistical analysis is completed and will not be shared with the manufacturer during study execution. The manufacturer company will not be involved in data analysis and all data will be independently analyzed by HADSI. The results of this study will be presented at conferences or published in a peer-review journal.

IPD Sharing Time Frame

1-2 months after conclusion of study

IPD Sharing Access Criteria

Results and statistical analysis will be available at the conclusion of the study

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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