Gestational Diabetes Clinical Trial
Official title:
Dilapan-S®: A Multicenter US E-registry
Verified date | November 2022 |
Source | Medicem Technology s.r.o. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Objective of this registry is to collect a representative set of real world data on the use of Dilapan-S® for pre-induction cervical ripening in daily clinical practice. Upon completion of the registry, relevant collected data will be analyzed and published.
Status | Enrolling by invitation |
Enrollment | 1200 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Pregnant woman whose plan of care is induction of labor - Maternal age = 18 years - Gestational age = 37 +0/7 weeks - Dilapan-S® used for cervical ripening Exclusion Criteria: - Data not available for extraction |
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas Medical Branch | Galveston | Texas |
Lead Sponsor | Collaborator |
---|---|
Medicem Technology s.r.o. | The University of Texas Medical Branch, Galveston |
United States,
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
Martin JA, Hamilton BE, Osterman MJ, Driscoll AK, Mathews TJ. Births: Final Data for 2015. Natl Vital Stat Rep. 2017 Jan;66(1):1. — View Citation
Rayburn WF. Preinduction cervical ripening: basis and methods of current practice. Obstet Gynecol Surv. 2002 Oct;57(10):683-92. Review. — 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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of overall vaginal delivery | right after child delivery | ||
Secondary | Rate of vaginal delivery within 24 hours | 24 hours | ||
Secondary | Rate of vaginal delivery within 36 hours | 36 hours | ||
Secondary | Time to reach active stage of labor defined as =6 cm | minutes | 48 hours | |
Secondary | Change in Bishop score | scale 0-13 (positive gain in Bishop score is considered to be a positive consequence of the intervention) | 48 hours | |
Secondary | Rate of spontaneous vaginal delivery | right after child delivery | ||
Secondary | Rate of operative vaginal delivery | right after child delivery | ||
Secondary | Rate of caesarean sections | right after child delivery |
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