Cervix Monitor for Detection Conditions Leading to Spontaneous Preterm Delivery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

270 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-03

Study Completion Date

2022-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Preterm birth is a leading cause of neonatal mortality despite of numerous advances and intensive research in perinatal medicine. Almost one million children die every year due to the complications of preterm birth and rates are on the rise. Of the 14 million survivors per year, most face a lifetime of disability, including learning disabilities, visual and hearing impairments. The majority of preterm birth happen spontaneously (SPTD) which is often a multi factorial event, precocious cervical softening, shortening and dilatation are a common underlying factor. In the scope of this project the investigators propose to develop and clinically validate a new device, Cervix Monitor (CM), for detecting cervix conditions leading to SPTD and its risk assessment.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Labor Status Monitor for Diagnosing True vs False Labor in Preterm Patients

NCT06157203

PreTerm Labor Threatened Preterm Labor Preterm Birth

RECRUITING

Predicting Infant Extubation Using Diaphragm Surface Electromyography

NCT02878993

Infant, Newborn, Disease

COMPLETED

Clinical Grade MIS Device for Cervical Assessment to Predict Preterm Birth

NCT04008485

Preterm Birth

COMPLETED NA

Prediction of Adverse Outcome Using Fetal MRI in Pregnancies at Risk of Preterm Birth

NCT05164432

Preterm Birth Complication

RECRUITING NA

Computerized Cardiotocography Monitoring of Fetuses With pPROM

NCT04632017

Cardiotocography Premature Rupture of Membrane Rupture of Membranes; Premature +2 more

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

SPTD is closely related to a premature cervical ripening. The scientific basis for the proposed project is that the elasticity modulus of a cervix is a more sensitive parameter characterizing the stage of cervical ripening. The main component of the cervical tissue is 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 (CM) measuring cervical elasticity (stiffness) and cervical length (effacement) appears to be an adequate approach for identifying pregnant women at high risk of SPTD. The CM is based on measuring applied pressure to the cervix by a tactile sensor array (stress data) and ultrasound measurement of cervix length (strain data). Tactile and ultrasound sensors are allocated on the tip of the measuring part of vaginal probe. The discovery of novel bio markers that could reliably identify women who will subsequently deliver preterm, may allow for timely medical intervention and targeted therapeutic treatments aimed at improving maternal and fetal outcomes.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preterm Birth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Gestational age from 24 to 28 weeks at time of Cervix Monitor measurement
* Singleton in the current pregnancy

Exclusion Criteria

* Fatal anomaly
* History of fetal reduction in the current pregnancy to the singleton gestation
* Preterm rapture of membranes
* Current or planned cervical cerclage
* Planned indicated preterm delivery
* Active known cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder
* Ischemic heart disease and or arrhythmia
* Active skin infection or ulceration within the vaginal/vulva (Herpes infection)

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No