ObstetricsNCT00502918
Clinical Feasibility of Computerized Labor Monitor (CLM) -Heart Application (HA)
An observational study of Obstetrics and Labor, run by Barnev Ltd at 1 site in Israel.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetrics, Labor
- What is being tested?
- CLM - HA Continuous Monitoring System Heart Application
- Type of treatment
- Medical device
- How many people
- 3 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2008to Aug 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Laboring women reffered to the maternity center in active labor (3cm - 7 cm) dilataion and contraction
Who may be able to join
- Laboring women refered to the maternity center in active labor (3cm dilatation and contraction)
- Gestational age 37-42 weeks. (GA)
- Single Fetus.
- Subjects who understand, agreed and signed the informed consent form.
Who cannot join
- Women with abnormal placentation (Placenta previa) -
- Abnormal fetal presentation (Breech presentation).
- Maternal History of HIV and/or blood transmitted Hepatitis and /or active genital Herpes.
- Need for immediate delivery (cord prolapsed or suspected placental abruption)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study -Clinical Feasibility of Computerized Labor Monitor (CLM) -Heart Application
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
Read the 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.
- Conditions
- Obstetrics, Labor
- Being tested
- CLM - HA Continuous Monitoring System Heart Application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLM - HA Continuous Monitoring System Heart ApplicationDevice
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Device: CLM - HA Continuous Monitoring System Heart Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitoring fetal heart movement
Measured: During labour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2007 (estimated)
- Study startFeb 2008
- Primary completionJul 2008 (estimated)
- Study completionAug 2008
Why it stopped: The study was terimnated - low rate of cases
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObstetricsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barnev Ltd
- Sponsor type
- University, hospital or other
- Investigators
- Ariel Many, MD, Principal investigator, Sackler School od Medicine , Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502918
- Sponsor's protocol ID
- TASMC-07-AM-279-CTIL
- Status last verified
- Jul 2007
- First submitted
- 17 Jul 2007
- Last updated
- 29 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study -Clinical Feasibility of Computerized Labor Monitor (CLM) -Heart Application
- ClinicalTrials.gov ID
- NCT00502918
- Acronym / sponsor ID
- TASMC-07-AM-279-CTIL
- Conditions
- Obstetrics, Labor
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terimnated - low rate of cases
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Barnev LtdUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jul 2008 (estimated)
- Study completion
- Aug 2008 (actual)
- First posted
- 18 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: CLM - HA Continuous Monitoring System Heart Application |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Laboring women reffered to the maternity center in active labor (3cm - 7 cm) dilataion and contraction
Key inclusion criteria (4 listed)
- Laboring women refered to the maternity center in active labor (3cm dilatation and contraction)
- Gestational age 37-42 weeks. (GA)
- Single Fetus.
- Subjects who understand, agreed and signed the informed consent form.
Key exclusion criteria (4 listed)
- Women with abnormal placentation (Placenta previa) -
- Abnormal fetal presentation (Breech presentation).
- Maternal History of HIV and/or blood transmitted Hepatitis and /or active genital Herpes.
- Need for immediate delivery (cord prolapsed or suspected placental abruption)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLM - HA Continuous Monitoring System Heart Application | Device | 1 |
Primary outcome
Monitoring fetal heart movement
Time frame: During labour
Results and safety
The study was stopped early (reason given: The study was terimnated - low rate of cases). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariel Many, MD principal investigator
Sackler School od Medicine , Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstetrics and Labor, run by Barnev Ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terimnated - low rate of cases). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monitoring fetal heart movement (time frame: During labour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2009.