ObstetricsBTNCT00840710
Clinical Feasibility of Birth- Track II System
An observational study of Obstetrics and Labor, run by Barnev Ltd at 1 site in Israel.
Trial summary
The Study purpose is to monitor the cervix dilation, head descent, FHR and to follow contraction in a women in active labor. Read more about this study
- Who is it for?
- Ages 17 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetrics, Labor
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2010to Aug 2010
- 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 17 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Women in active labor
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)
- 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.
Jacob Bornestein, Phd. contact
About this study
The Study purpose is to monitor the cervix dilation, head descent, FHR and to follow contraction in a women in active labor.
- Conditions
- Obstetrics, Labor
- Keywords
- 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 posted10 Feb 2009 (estimated)
- Study startFeb 2010
- Study completionAug 2010 (estimated)
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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barnev Ltd
- Sponsor type
- University, hospital or other
- Investigators
- Jacob Bornstein, PhD, Principal investigator, Westren Gallilie Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840710
- Sponsor's protocol ID
- BT-II-IS-001
- Acronym
- BT
- Status last verified
- Feb 2009
- First submitted
- 8 Feb 2009
- 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
- Clinical Feasibility of Birth- Track II System
- ClinicalTrials.gov ID
- NCT00840710
- Acronym / sponsor ID
- BT / BT-II-IS-001
- Conditions
- Obstetrics, Labor
- Keywords
- women in active labor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Barnev LtdUniversity, hospital or other
- Study start
- Feb 2010
- Study completion
- Aug 2010 (estimated)
- First posted
- 10 Feb 2009 (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 purpose is to monitor the cervix dilation, head descent, FHR and to follow contraction in a women in active labor.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 17 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Women in active labor
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 (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.
Primary outcome
Not reported in the source record.
Results and safety
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.
Jacob Bornestein, Phd. contact
Jacob Bornstein, PhD principal investigator
Westren Gallilie Hospital
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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacob Bornestein, Phd. (049107207), or a site near the patient. 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 29 Dec 2009.