NCT04529837

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 28, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

August 9, 2023

Status Verified

August 1, 2023

Enrollment Period

9 months

First QC Date

August 17, 2020

Last Update Submit

August 7, 2023

Conditions

Cervical DilationInduction of LaborUltrasound Evaluation

Outcome Measures

Primary Outcomes (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.

    12 hours

Secondary Outcomes (2)

  • Gauze placement and rod diameter

    12 hours

  • Patient satisfaction

    12 hours

Study Arms (2)

Pregnant individuals with Dilapan-S only

22 women received Dilapan-S rods without gauze at start of induction.

Other: 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

Interventions

GauzeOTHER

placement of gauze

Pregnant individuals with Dilapan-S plus gauze placement
No gauzeOTHER

no gauze

Pregnant individuals with Dilapan-S only

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Virginia Medical School

Norfolk, Virginia, 23501, United States

Location

Related Publications (10)

  • 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.

    PMID: 26538408BACKGROUND

  • 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: 30089070BACKGROUND

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

    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: 30790569BACKGROUND

  • 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.

    PMID: 25618749BACKGROUND

  • 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: 30107363BACKGROUND

  • 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.

    PMID: 22114527BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 29667082BACKGROUND

  • 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.

    PMID: 24735056BACKGROUND

Related Links

Study Officials

  • Elizabeth Seagraves, DO

    Eastern Virginia Medical School MFM Fellowship

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Maternal Fetal Medicine Fellow

Study Record Dates

First Submitted

August 17, 2020

First Posted

August 28, 2020

Study Start

October 1, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

August 9, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
1-2 months after conclusion of study
Access Criteria
Results and statistical analysis will be available at the conclusion of the study

Locations

US(1)