PregnancyBirthTrackNCT01005667
Study to Determine if Monitoring of Labor Shortens the Time to Delivery
A study testing BirthTrack in people with Pregnancy, run by Barnev, Inc. at 1 site in Canada.
Trial summary
The purpose of this study is to test the hypothesis that using the BirthTrack for management of labor shortens the time to delivery and thus improves both maternal and perinatal outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- BirthTrack
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must be ≥ 18 years old
- Nulliparous
- Singleton fetus in vertex presentation
- Gestational age 36-0/7 or more
- Reassuring fetal heart tracing
Who cannot join
- Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study
- Low lying placenta (edge 3cm or less from cervix)
- Known or suspected fetal or maternal infection
- Maternal thrombocytopenia (platelet count <100,000)
- Maternal bleeding disorder
- Women with previous uterine surgery
Show all 13Show fewer
- Known major fetal malformation
- Suspected fetal growth restriction (EFW<10th percentile)
- Subjects with significant psychiatric history
- Major maternal morbidity (e.g. major cardiac disease)
- Subjects with indication for immediate delivery
- Limit on cervical dilation (e.g., up to 7 cm.)
- Prolonged rupture of membranes (i.e., > 24 hours)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Labor Using the BirthTrack Computerized Labor Monitoring System
The purpose of this study is to test the hypothesis that using the BirthTrack for management of labor shortens the time to delivery and thus improves both maternal and perinatal outcomes.
- Conditions
- Pregnancy
- Being tested
- BirthTrack
- Keywords
- Nulliparous women in spontaneous labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BirthTrackDevice
Also called Computerized Labor Monitoring System
Measurement of cervical dilation and head station
| Study group | Role | What they receive |
|---|---|---|
| BirthTrack Monitor | Experimental | Not described Receives: Device: BirthTrack |
| Control - no BirthTrack Monitor | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shortened time to vaginal delivery
Measured: Length of labor until delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
Why it stopped: Lack of funding for the company has resulted in termination of the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barnev, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Barak M Rosenn, MD, Principal investigator, St. Luke's-Roosevelt Hospital CenterDan Farine, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005667
- Sponsor's protocol ID
- BBT1600
- Acronym
- BirthTrack
- Status last verified
- Oct 2009
- First submitted
- 30 Oct 2009
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Labor Using the BirthTrack Computerized Labor Monitoring System
- ClinicalTrials.gov ID
- NCT01005667
- Acronym / sponsor ID
- BirthTrack / BBT1600
- Conditions
- Pregnancy
- Keywords
- Nulliparous women in spontaneous labor
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding for the company has resulted in termination of the study.
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Barnev, Inc.Industry (pharma, biotech, devices)
- First posted
- 2 Nov 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 purpose of this study is to test the hypothesis that using the BirthTrack for management of labor shortens the time to delivery and thus improves both maternal and perinatal outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BirthTrack Monitor | Experimental | Device: BirthTrack |
| Control - no BirthTrack Monitor | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient must be ≥ 18 years old
- Nulliparous
- Singleton fetus in vertex presentation
- Gestational age 36-0/7 or more
- Reassuring fetal heart tracing
Key exclusion criteria (13 listed)
- Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study
- Low lying placenta (edge 3cm or less from cervix)
- Known or suspected fetal or maternal infection
- Maternal thrombocytopenia (platelet count <100,000)
- Maternal bleeding disorder
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 |
|---|---|---|
| BirthTrackAlso: Computerized Labor Monitoring SystemMeasurement of cervical dilation and head station | Device | BirthTrack Monitor |
Primary outcome
Shortened time to vaginal delivery
Time frame: Length of labor until delivery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
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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.
Barak M Rosenn, MD principal investigator
St. Luke's-Roosevelt Hospital Center
Dan Farine, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BirthTrack in people with Pregnancy, run by Barnev, Inc. at 1 site in Canada.
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 5 inclusion and 13 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: withdrawn, as of the sponsor's last update on 23 Jun 2011. 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 Canada. 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 withdrawn before enrolling participants, so there are no results.
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?
Shortened time to vaginal delivery (time frame: Length of labor until delivery). 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 23 Jun 2011.