Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
44 participants
OBSERVATIONAL
2020-10-01
2021-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pregnant individuals with Dilapan-S only
22 women received Dilapan-S rods without gauze at start of induction.
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.
Gauze
placement of gauze
Interventions
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Gauze
placement of gauze
No gauze
no gauze
Eligibility Criteria
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Inclusion Criteria
* 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
* Intrauterine fetal demise
* Contraindications to vaginal delivery.
* BMI \> 45
* Vaginal bleeding
* Clinically evident genital tract infection
18 Years
45 Years
FEMALE
Yes
Sponsors
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Eastern Virginia Medical School
OTHER
Responsible Party
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Elizabeth Seagraves
Maternal Fetal Medicine Fellow
Principal Investigators
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Elizabeth Seagraves, DO
Role: PRINCIPAL_INVESTIGATOR
Eastern Virginia Medical School MFM Fellowship
Locations
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Eastern Virginia Medical School
Norfolk, Virginia, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Women's Health Fastfacts
Cervical Length Education and Review
Other Identifiers
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20-40-FB-0097
Identifier Type: -
Identifier Source: org_study_id
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