Clinical Evaluation of New Computerized Labor Monitoring System (CLM)

Barnev

Status: Terminated

Conditions: Labor; Obstetrics

Study type: Observational

Funder types: Other

Identifiers

NCT00496899

TASMC-07-AM-355-CITL

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 3 patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

3 participants in 1 patient group

1

Description:

Women in active labor