Hannah Cervical Cup (2 mm) for Premature Births

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Intermountain Utah Valley Hospital, Provo, UT
Premature Births+6 More
Hannah Cervical Cup (2 mm Delta) - Device
Eligibility
18 - 65
Female
What conditions do you have?
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Study Summary

The goal of this Phase I clinical trial is to generate proof-of-concept data to demonstrate that a cervical cup in combination with vacuum application will create negative pressure on uterine cervical tissue, thereby creating immediate cervical stiffness in order to prevent cervical ripening that is associated with spontaneous preterm birth. Aim #1: Conduct a Phase I clinical study. 1A: Evaluate the ability of a cervical cup to improve cervical tissue physiology of uterine cervices in vivo for nonpregnant women. 1B: Evaluate the ability of a cervical cup to be safely placed and removed on uterine cervices in vivo for nonpregnant women.

Eligible Conditions

  • Soft Cervix
  • Cervical Incompetence
  • Cervical Insufficiency
  • Short Cervix
  • Premature Births

Treatment Effectiveness

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 1 month

1 month
Safety: incidence (in number) of Treatment-Related Adverse Events
15-30 minutes
Feasibility: increases in cervical stiffness (in SWS m s-1) with cup and pressure application

Trial Safety

Trial Design

3 Treatment Groups

Hannah Cervical Cup (2 mm)
1 of 3
Hannah Cervical Cup (6 mm)
1 of 3
Hannah Cervical Cup (4 mm)
1 of 3
Experimental Treatment

40 Total Participants · 3 Treatment Groups

Primary Treatment: Hannah Cervical Cup (2 mm) · No Placebo Group · Phase 1

Hannah Cervical Cup (2 mm)
Device
Experimental Group · 1 Intervention: Hannah Cervical Cup (2 mm Delta) · Intervention Types: Device
Hannah Cervical Cup (6 mm)
Device
Experimental Group · 1 Intervention: Hannah Cervical Cup (6 mm Delta) · Intervention Types: Device
Hannah Cervical Cup (4 mm)
Device
Experimental Group · 1 Intervention: Hannah Cervical Cup (4 mm Delta) · Intervention Types: Device

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month
Closest Location: Intermountain Utah Valley Hospital · Provo, UT
N/AFirst Recorded Clinical Trial
1 TrialsResearching Premature Births
0 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · Female Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.