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Cervical DilationNCT04529837

Ultrasound Assessment of DILAPAN-S

An observational study of Cervical Dilation and Induction of Labor, run by Eastern Virginia Medical School at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
Gauze and No gauze
How many people
44 participants
Where
1 siteUnited States
Study dates
1 Oct 2020to 30 Jun 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Pregnant individuals at term undergoing labor induction at single academic institution.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23501

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Gauze, No gauze

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GauzeOther

    placement of gauze

  • No gauzeOther

    no gauze

Study groups in NCT04529837
Study groupRoleWhat they receive
Pregnant individuals with Dilapan-S only22 women received Dilapan-S rods without gauze at start of induction.
Receives: Other: No gauze
Pregnant individuals with Dilapan-S plus gauze placement22 women received Dilapan-S rods with 1 gauze at start of induction.
Receives: Other: Gauze

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diameter change of Dilapan-S

    Rod diameters of Dilapan-S rods were measured via transvaginal ultrasound at 3,6,8, and 12 hours after placement.

    Measured: 12 hours

Secondary outcomes (2)

  1. Gauze placement and rod diameter

    Rod diameters of Dilapan-S rods plus gauze placement were measured via transvaginal ultrasound at 3,6,8, and 12 hours after placement.

    Measured: 12 hours

  2. Patient satisfaction

    Patient satisfaction scores were assessed based on gauze versus no gauze placement.

    Measured: 12 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2020
  2. Study start1 Oct 2020
  3. Primary completion30 Jun 2021
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04529837
Sponsor's protocol ID
20-40-FB-0097
Status last verified
Aug 2023
First submitted
17 Aug 2020
Last updated
9 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: 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.

Publications

  • Chen W, Xue J, Peprah MK, Wen SW, Walker M, Gao Y, Tang Y. A systematic review and network meta-analysis comparing the use of Foley catheters, misoprostol, and dinoprostone for cervical ripening in the induction of labour. BJOG. 2016 Feb;123(3):346-54. doi: 10.1111/1471-0528.13456. Epub 2015 Nov 5.

    PubMed 26538408

  • 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.

    PubMed 30089070

  • American College of Obstetricians and Gynecologists. Induction of Labor. ACOG Practice Bulletin No. 107. August 2009.

  • 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.

    PubMed 30790569

  • Drunecky T, Reidingerova M, Plisova M, Dudic M, Gdovinova D, Stoy V. Experimental comparison of properties of natural and synthetic osmotic dilators. Arch Gynecol Obstet. 2015 Aug;292(2):349-54. doi: 10.1007/s00404-015-3623-3. Epub 2015 Jan 25.

    PubMed 25618749

  • 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.

    PubMed 30107363

  • Chambers DG, Willcourt RJ, Laver AR, Baird JK, Herbert WY. Comparison of Dilapan-S and laminaria for cervical priming before surgical pregnancy termination at 17-22 weeks' gestation. Int J Womens Health. 2011;3:347-52. doi: 10.2147/IJWH.S25551. Epub 2011 Oct 20.

    PubMed 22114527

  • Abuhamad, A. Ultrasound in Obstetrics and Gynecology: A Practical Approach. Chapter 1: Basic Physical Principles of Medical Ultrasound. 2014.

  • Sung YT, Wu JS. The Visual Analogue Scale for Rating, Ranking and Paired-Comparison (VAS-RRP): A new technique for psychological measurement. Behav Res Methods. 2018 Aug;50(4):1694-1715. doi: 10.3758/s13428-018-1041-8.

    PubMed 29667082

  • Kliger M, Stahl S, Haddad M, Suzan E, Adler R, Eisenberg E. Measuring the Intensity of Chronic Pain: Are the Visual Analogue Scale and the Verbal Rating Scale Interchangeable? Pain Pract. 2015 Jul;15(6):538-47. doi: 10.1111/papr.12216. Epub 2014 Apr 16.

    PubMed 24735056

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Dilation and Induction of Labor, run by Eastern Virginia Medical School at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diameter change of Dilapan-S (time frame: 12 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04529837, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.

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