Study Summary
This trial is comparing two methods of inducing labor: one mechanical and one with medication.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: 720-2160 minutes
12-14 hours
Pain over duration of cervical ripening
Rate of device expulsion prior to admission
Rate of onset of labor prior to planned admission
12-36 hours
10 minute Apgar score <7
Base excess >12
Incidence of intra-amniotic infection
Incidence of post-partum hemorrhage
Incidence of shoulder dystocia
Rate of cesarean delivery
Rate of operative vaginal delivery
Umbilical cord gas pH <7
12-72 hours
Composite score of adverse neonatal outcomes
Composite score of serious maternal morbidity or mortality
24-36 hours
Patient satisfaction with cervical ripening agent
720-2160 minutes
Time from start of cervical ripening to delivery
First hour
Pain of insertion
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Hygroscopic cervical dilators
1 of 2
Trans-cervical cervical balloon
1 of 2
Experimental Treatment
300 Total Participants · 2 Treatment Groups
Primary Treatment: Trans-cervical cervical balloon · No Placebo Group · N/A
Hygroscopic cervical dilators
Device
Experimental Group · 1 Intervention: Hygroscopic cervical dilator · Intervention Types: DeviceTrans-cervical cervical balloon
Device
Experimental Group · 1 Intervention: Trans-cervical cervical balloon · Intervention Types: DeviceTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 720-2160 minutes
Who is running the clinical trial?
Ochsner Health SystemLead Sponsor
88 Previous Clinical Trials
185,483 Total Patients Enrolled
Northwell HealthOTHER
425 Previous Clinical Trials
493,230 Total Patients Enrolled
Brigid McCue, MDPrincipal InvestigatorNorthwell Health
Eligibility Criteria
Age 18 - 40 · Female Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Gilson, George J., Debora J. Russell, Luis A. Izquierdo, Clifford R. Qualls, and Luis B. Curet. 1996. “A Prospective Randomized Evaluation of a Hygroscopic Cervical Dilator, Dilapan, in the Preinduction Ripening of Patients Undergoing Induction of Labor”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/s0002-9378(96)70264-8.
- Kuper, Spencer G., Victoria C. Jauk, David M. George, Rodney K. Edwards, Jeff M. Szychowski, Sara E. Mazzoni, Michelle J. Wang, et al.. 2018. “Outpatient Foley Catheter for Induction of Labor in Parous Women”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000002678.
- SCISCIONE, A. 2001. “Transcervical Foley Catheter for Preinduction Cervical Ripening in an Outpatient Versus Inpatient Setting”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/s0029-7844(01)01579-4.
- Shindo, Ryosuke, Shigeru Aoki, Naohiro Yonemoto, Yuriko Yamamoto, Junko Kasai, Michi Kasai, and Etsuko Miyagi. 2017. “Hygroscopic Dilators Vs Balloon Catheter Ripening of the Cervix for Induction of Labor in Nulliparous Women at Term: Retrospective Study”. Edited by Shannon M. Hawkins. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0189665.
- Bedder, Casey, Matthew Hoffman, Kelly Ruhstaller, Phillip Shlossman, and Anthony Sciscione. 2013. “The Timing of Adverse Events with Foley Catheter Preinduction Cervical Ripening; Implications for Outpatient Use”. American Journal of Perinatology. Georg Thieme Verlag KG. doi:10.1055/s-0033-1359718.
- Kuper, Spencer G., Victoria C. Jauk, David M. George, Rodney K. Edwards, Jeff M. Szychowski, Sara E. Mazzoni, Michelle J. Wang, et al.. 2018. “Outpatient Foley Catheter for Induction of Labor in Parous Women”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000002678.
- SCISCIONE, A. 2001. “Transcervical Foley Catheter for Preinduction Cervical Ripening in an Outpatient Versus Inpatient Setting”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/s0029-7844(01)01579-4.
- Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. doi: 10.1016/s0029-7844(01)01579-4.
- Gilson GJ, Russell DJ, Izquierdo LA, Qualls CR, Curet LB. A prospective randomized evaluation of a hygroscopic cervical dilator, Dilapan, in the preinduction ripening of patients undergoing induction of labor. Am J Obstet Gynecol. 1996 Jul;175(1):145-9. doi: 10.1016/s0002-9378(96)70264-8.
- 2019. "Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03752073.
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