Ultrasound Assessment of DILAPAN-S

Induction of Labor Clinical Trial

Official title:

Longitudinal Ultrasound Evaluation of Dilapan-S During Cervical Ripening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04529837
• Other study ID #: 20-40-FB-0097
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2023
• Source: Eastern Virginia Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Dilation
• Induction of Labor
• Ultrasound Evaluation

Intervention

Other:
• Gauze
placement of gauze
• No gauze
no gauze

Locations

Country	Name	City	State
United States	Eastern Virginia Medical School	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Virginia Medical School

Country where clinical trial is conducted

United States, 

References & Publications (10)

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	12 hours
Secondary	Patient satisfaction	Patient satisfaction scores were assessed based on gauze versus no gauze placement.	12 hours

External Links

•   Cervical Length Education and Review
•   Recent declines in induction of labor by gestational age
•   Women's Health Fastfacts