Clinical Feasibility of Computerized Labor Monitor (CLM) -Heart Application (HA)

Terminated

• Conditions: Obstetrics; Labor
• Interventions: Device: CLM - HA Continuous Monitoring System Heart Application

• Registration Number: NCT00502918
• Lead Sponsor: Barnev Ltd

Brief Summary

The study is a feasibility study to check the possibility of tracking the heart rate of the fetus and to translate the outcome to the progress of the labor

Detailed 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.

Study Timeline

• Status Verified: 2007-07
• Study First Submitted: 2007-07-17
• Study First Submitted QC: 2007-07-17
• Study First Posted: 2007-07-18
• Study Start: 2008-02
• Primary Completion: 2008-07
• Study Completion: 2008-08
• Last Update Submitted: 2009-12-27
• Last Update Posted: 2009-12-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 3

Inclusion Criteria

1. Laboring women refered to the maternity center in active labor (3cm dilatation and contraction)
2. Gestational age 37-42 weeks. (GA)
3. Single Fetus.
4. Subjects who understand, agreed and signed the informed consent form.

Exclusion Criteria

1. Women with abnormal placentation (Placenta previa) -
2. Abnormal fetal presentation (Breech presentation).
3. Maternal History of HIV and/or blood transmitted Hepatitis and /or active genital Herpes.
4. Need for immediate delivery (cord prolapsed or suspected placental abruption)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	CLM - HA Continuous Monitoring System Heart Application	-

Primary Outcome Measures

Name	Time	Method
Monitoring fetal heart movement	During labour

Trial Locations

Locations (1)

Tel Aviv Soraski medical center; 🇮🇱 Tel - Aviv, Israel