Cervix Monitor for Elasticity and Length Measurements
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 21 - 44 |
| Updated: | 2/21/2018 |
| Start Date: | May 1, 2017 |
| End Date: | February 14, 2018 |
Cervix Monitor for Risk Assessment of Spontaneous Preterm Delivery
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.
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.
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 .
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 .
Inclusion Criteria:
1. Adult women age 21-44 years
2. Non-pregnant women, or
3. Pregnant women
Exclusion Criteria:
1. Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder
2. Ongoing or prior radiation therapy for abdominal or pelvic cancer
3. Recent (less than four months) pelvic surgery
4. Surgically absent uterus, rectum or bladder
5. Significant circulatory or cardiac conditions that could cause excessive risk from the
examination as determined by attending physician
6. Severe abdominal or pelvic adhesions preventing access to pertinent anatomy
7. Known or suspected bleeding disorder
8. HIV or hepatitis B positive serology
9. Warty lesions on the vulva
10. Extensive varicose veins on the vulva
11. Active skin infection or ulceration within the vagina/vulva (Herpes infection)
12. Presence of a vaginal septum
13. Severe hemorrhoids
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