PregnancyNCT01093144
Assessment of Pelvis Diameters as a Predictor for the Mode of Delivery ,Using Non-invasive, Ultrasound Based Measurements
A study testing pelvic measurements using the LaborPro Device in people with Pregnancy and Women, run by Trig Medical Inc at 1 site in Israel.
Trial summary
Assessing the relation between the Pelvis diameters measured by the LaborPro, and the mode of delivery(normal vaginal delivery/instrumental delivery/Caesarean section. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- What is being tested?
- pelvic measurements using the LaborPro Device
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2010to Apr 2010
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- A subject is eligible to participate in the study if she meets all of the following inclusion criteria:
- Singleton pregnancy
- Pregnant adult woman in labor
- Willing to participate in the study and understands the study procedures
Who cannot join
- A subject is not eligible for participation in this study if he/she meets any of the following exclusion criteria scheduled for c/s active infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Pelvis Diameters as a Predictor for the Mode of Delivery ,Using Non-invasive, Ultrasound Based Measurements.
Assessing the relation between the Pelvis diameters measured by the LaborPro, and the mode of delivery(normal vaginal delivery/instrumental delivery/Caesarean section.
Read the detailed description
Assessing the relation between the Pelvis diameters measured by the LaborPro, and the mode of delivery(normal vaginal delivery/instrumental delivery/Caesarean section.
- Being tested
- pelvic measurements using the LaborPro Device
- Keywords
- Delivery mode, pelvic measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic measurements using the LaborPro DeviceDevice
pelvic measurements using the LaborPro Device,ultrasound non invasive measurements
What is being measured
The primary outcome is the main question the study is designed to answer.
pelvis measurements influence on the Delivery mode
pregnant woman's during a routine visit in the ultrasound unit will be requested to sign a concent and will undergo pelvic measurement using the LaborPro system.
statistic analysis will ensue in order to ascertain the relationship between pelvic measurement and the mode of delivery.
Measured: labor and delivery process
Secondary outcomes (1)
the influence of maternal parameters on delivery mode.
Assessing the influence of relevant obstetric and maternal parameters on delivery mode in relation to the study measured parameters
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2010 (estimated)
- Study completionApr 2010 (estimated)
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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trig Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yinon Gilboa, Dr, Principal investigator, Tel Hashomer Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093144
- Sponsor's protocol ID
- CLP 006/2010
- Status last verified
- Mar 2010
- First submitted
- 24 Mar 2010
- Last updated
- 25 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pelvis Diameters as a Predictor for the Mode of Delivery ,Using Non-invasive, Ultrasound Based Measurements.
- ClinicalTrials.gov ID
- NCT01093144
- Acronym / sponsor ID
- CLP 006/2010
- Keywords
- Delivery mode, pelvic measurement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Trig Medical IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 25 Mar 2010 (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.
Assessing the relation between the Pelvis diameters measured by the LaborPro, and the mode of delivery(normal vaginal delivery/instrumental delivery/Caesarean section.
Detailed description
Assessing the relation between the Pelvis diameters measured by the LaborPro, and the mode of delivery(normal vaginal delivery/instrumental delivery/Caesarean section.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- A subject is eligible to participate in the study if she meets all of the following inclusion criteria:
- Singleton pregnancy
Key exclusion criteria (1 listed)
- A subject is not eligible for participation in this study if he/she meets any of the following exclusion criteria scheduled for c/s active infection
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 |
|---|---|---|
| pelvic measurements using the LaborPro Devicepelvic measurements using the LaborPro Device,ultrasound non invasive measurements | Device | – |
Primary outcome
pelvis measurements influence on the Delivery mode
Time frame: labor and delivery process
pregnant woman's during a routine visit in the ultrasound unit will be requested to sign a concent and will undergo pelvic measurement using the LaborPro system. statistic analysis will ensue in order to ascertain the relationship between pelvic measurement and the mode of delivery.
1 secondary outcome
the influence of maternal parameters on delivery mode.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2010.
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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.
Yinon Gilboa, Dr principal investigator
Tel Hashomer Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pelvic measurements using the LaborPro Device in people with Pregnancy and Women, run by Trig Medical Inc 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 1 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 25 Mar 2010. 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 Yinon Gilboa, Dr (+972-544776357, yinon-si@inter.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pelvis measurements influence on the Delivery mode (time frame: labor and delivery process). 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 25 Mar 2010.