Preterm Birth
Conditions
Brief 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.
Detailed description
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 .
Interventions
OTHERMeasurement
Measurement of cervix elasticity and length measurements is not an intervention
Sponsors
Princeton Urogynecology
Rutgers, The State University of New Jersey
Advanced Tactile Imaging, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 44 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cervix Elasticity | During examination procedure | Young's modulus of the cervix at 4 locations. Units of measurement is kPa. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cervix Length | During examination procedure | Cervix length in mm |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Non-pregnant Women Non-pregnant women with normal pelvic floor
Cervix Monitor: Cervix elasticity and length measurements by Cervix Monitor | 10 |
| Group 2: Pregnant Women Pregnant women; 22-29 weeks of pregnancy
Cervix Monitor: Cervix elasticity and length measurements by Cervix Monitor | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Group 2: Pregnant Women | Total | Group 1: Non-pregnant Women |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 20 Participants | 10 Participants |
| Age, Continuous | 32.4 years STANDARD_DEVIATION 5.6 | 34.2 years STANDARD_DEVIATION 6.5 | 35.9 years STANDARD_DEVIATION 7.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 8 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 11 Participants | 8 Participants |
| Region of Enrollment United States | 10 Participants | 20 Participants | 10 Participants |
| Sex: Female, Male Female | 10 Participants | 20 Participants | 10 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Cervix Elasticity
Young's modulus of the cervix at 4 locations. Units of measurement is kPa.
Time frame: During examination procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-pregnant Women | Cervix Elasticity | 54 kPa | Standard Deviation 17 |
| Pregnant Women | Cervix Elasticity | 19.7 kPa | Standard Deviation 15.4 |
Secondary
Cervix Length
Cervix length in mm
Time frame: During examination procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-pregnant Women | Cervix Length | 42 mm | Standard Deviation 13 |
| Pregnant Women | Cervix Length | 30.7 mm | Standard Deviation 6.6 |