Cervix Monitor for Elasticity and Length Measurements

Study Overview
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Brief Summary
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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.

Detailed Description
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The uterine cervix has to provide structural integrity and mechanical resistance to ensure normal development of the fetus as the uterus expands to accommodate the fetus growth. Preterm delivery is closely related to a premature cervical ripening. The scientific bases for the proposed project is the elasticity modulus of a cervix is a more sensitive parameter characterizing the stage of cervical ripening. The main component of the cervix tissue is a collagen. Cervical ripening is the result of realignment of collagen, degradation of collagen cross-linking due to proteolytic enzymes. These processes affect the elasticity modulus of the cervical tissue. Therefore, assessment of cervix by a device measuring cervical elasticity and cervical length appears to be and adequate approach for identifying pregnant women at high risk of spontaneous preterm delivery. The primary cervical elasticity assessment currently used in clinical practice is relying on the evaluation of the cervix as hard, medium or soft. In the scope of this project the investigators propose to develop and clinically validate a new and cost-effective device, Cervix Monitor for detecting cervix conditions leading to SPTD and its risk assessment. The CM will be based on measuring of the applied pressure to the cervix by a tactile sensor array and ultrasound measurement of cervix length .

Official Title
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Cervix Monitor for Risk Assessment of Spontaneous Preterm Delivery

Conditions
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Preterm Birth

Intervention / Treatment
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* Other: Measurement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1: Non-pregnant women<br>Non-pregnant women with normal pelvic floor | Other: Measurement<br>* Measurement of cervix elasticity and length measurements is not an intervention<br>|
| Group 2: Pregnant women<br>Pregnant women; 22-29 weeks of pregnancy | Other: Measurement<br>* Measurement of cervix elasticity and length measurements is not an intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervix Elasticity | Young's modulus of the cervix at 4 locations. Units of measurement is kPa. | During examination procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervix Length | Cervix length in mm | During examination procedure |