N/A
N=20
Cervix Monitor for Elasticity and Length Measurements
Preterm Birth
Bottom Line
View on ClinicalTrials.gov: NCT03199079 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Cervix Elasticity — 54; 19.7 kPa
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Measurement (Other)
- Age
- Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Advanced Tactile Imaging, Inc.
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cervix Elasticity |
54; 19.7 | — |
| SECONDARY Cervix Length |
42; 30.7 | — |
Summary
Preterm birth is a leading global cause of neonatal mortality despite of numerous advances and intensive research in perinatal medicine. Almost one million children die each year due to complications of preterm birth and in almost all countries with reliable data, preterm birth rates are increasing. Of the 14 million survivors per year, many face a lifetime of disability, including learning disabilities, visual and hearing impairments. Spontaneous preterm delivery (SPTD) is often multi factorial event, precocious cervical softening, shortening and dilatation are a common denominator. The majority of preterm births happen spontaneously, though some are due to early induction of labor or cesarean birth, typically due to medical maternal of neonatal conditions.
Eligibility Criteria
Inclusion Criteria
- Adult women age 21-44 years
- Non-pregnant women, or
- Pregnant women
Exclusion Criteria
- Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder
- Ongoing or prior radiation therapy for abdominal or pelvic cancer
- Recent (less than four months) pelvic surgery
- Surgically absent uterus, rectum or bladder
- Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician
- Severe abdominal or pelvic adhesions preventing access to pertinent anatomy
- Known or suspected bleeding disorder
- HIV or hepatitis B positive serology
- Warty lesions on the vulva
- Extensive varicose veins on the vulva
- Active skin infection or ulceration within the vagina/vulva (Herpes infection)
- Presence of a vaginal septum
- Severe hemorrhoids
Data sourced from ClinicalTrials.gov (NCT03199079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.