ObstetricsCLMNCT00496899
Clinical Evaluation of New Computerized Labor Monitoring System
An observational study of Obstetrics and Labor, run by Barnev Ltd at 1 site in Israel.
Trial summary
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. 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
- How many people
- 3 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2007to Sep 2007
- 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 maternity center in active labor (3 -7 cm)dilatation and contraction
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of New Computerized Labor Monitoring System.
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.
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
- Keywords
- Labor, Obstetric, cervical dilatation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Women in active labor |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionSep 2007
- Study completionSep 2007
Why it stopped: The study was stopped prematurally due to low recruiting
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 of medicine, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00496899
- Sponsor's protocol ID
- TASMC-07-AM-355-CITL
- Acronym
- CLM
- Status last verified
- Jul 2007
- First submitted
- 4 Jul 2007
- Last updated
- 9 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of New Computerized Labor Monitoring System.
- ClinicalTrials.gov ID
- NCT00496899
- Acronym / sponsor ID
- CLM / TASMC-07-AM-355-CITL
- Conditions
- Obstetrics, Labor
- Keywords
- Labor, Obstetric, cervical dilatation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was stopped prematurally due to low recruiting
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Barnev LtdUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 6 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 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
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 | – | –Women in active labor |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Laboring women reffered to maternity center in active labor (3 -7 cm)dilatation and contraction
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: The study was stopped prematurally due to low recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2008.
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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 of 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 6 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 9 May 2008. 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 stopped prematurally due to low recruiting). 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.
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 9 May 2008.