Clinical Evaluation of New Computerized Labor Monitoring System

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

TERMINATED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-09-30

Brief Summary

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

The study is an open label feasibility study. The purpose of the study is to evaluate the ease of use of the Cervical ITR in terms of duration of attachment and number of detachments.

Detailed Description

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

Every year, millions of babies are born worldwide. Yet, despite great advances in medical technology, the method used to obtain the most critical parameter in labor management - cervix dilatation, remains a vaginal (manual) examination. This vaginal examination, intended to estimate the dilatation of the cervix and the progress of the baby's head, is inaccurate, non-continuous and involves the risk of infection to both fetus and mother. It is also uncomfortable to the mother. The consequences of infections or delayed treatment may range from simple complications to irreversible damage. Early detection of abnormal patterns of labor progress could prevent complications and shorten the labor process and hospitalization, thereby saving both aggravation and cost.

To truly manage the labor process, a labor management system is required. Such a system is expected to provide the obstetrical staff with the flow of accurate, continuous, real-time information, such as cervix dilatation.

Conditions

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

Obstetrics Labor

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Labor Obstetric cervical dilatation

Study Design

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

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Women in active labor

No interventions assigned to this group

Eligibility Criteria

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

Inclusion Criteria

* Laboring women referred to the Maternity Center in active labor (3cm dilatation and contractions).
* Gestational age 37-42 weeks. (GA)
* Single fetus
* Subjects who understood, agreed and signed the informed consent form

Exclusion Criteria

* Women with abnormal placentation (placenta previa)
* Women with coagulation abnormalities.
* Abnormal fetal presentation (breech presentation)
* Maternal History of HIV and/or blood transmitted hepatitis and/or active genital Herpes.
* Preterm premature rupture of membranes.
* Need for immediate delivery (cord prolapsed or suspected placental abruption

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Barnev

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ariel Many, MD

Role: PRINCIPAL_INVESTIGATOR

Sackler school of medicine, Tel Aviv University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tel Aviv soraski medical center

Tel Aviv, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TASMC-07-AM-355-CITL

Identifier Type: -

Identifier Source: org_study_id