PregnancyNCT01165879
Measuring Uterine Electrical Activity Throughout Pregnancy and Labor Measuring Uterine Electrical Activity Throughout Pregnancy and Labor
An observational study of Pregnancy, run by OB-Tools Ltd. at 1 site in Israel.
Trial summary
The EUM100pro (Electrical Uterine Monitor)is a uterine contraction monitor which measures uterine contractions based on the electrical activity of the uterine muscle.The study will compare the EUM100pro measurements to the already existing uterine contractions monitors (tocodynamometer and Intra Uterine Pressure… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Pregnancy
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- May 2010to May 2012
- 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Pergnant women which are admitted to Meir Medical Center with complaints of uterine contractions starting.
Who may be able to join
- Women at term with complaint of uterine contractions at Meir Medical Center
- Women at preterm with complaint of uterine contractions at Meir Medical Center.
- Women at gestational age >24 weeks
- Subjects who understood, agreed and signed the informed consent form
Who cannot join
- Subjects who refused to sign the informed consent form
- Abnormal fetal heart rate recording at admittance
- Subjects with indications for immediate delivery
- Subjects younger than 18 years of age
- Subjects at gestational age <24 weeks
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center
Kfar Saba, 44281
Tal Shental Biron, MD, +972-577482716, Tal.Biron-Shental@clalit.org.il
Tal Shental Biron, MD
About this study
The EUM100pro (Electrical Uterine Monitor)is a uterine contraction monitor which measures uterine contractions based on the electrical activity of the uterine muscle.The study will compare the EUM100pro measurements to the already existing uterine contractions monitors (tocodynamometer and Intra Uterine Pressure Catheter) in pregnant women with complaints of uterine contractions.
Read the detailed description
The main objective of the study is to demonstrate that the EUM100pro is as good as the current methods for monitoring pregnancy in labor (tocodynamometer, IUPC) in measuring uterine contractions. This will be performed by measuring the expectancy of time differences between the tocodynamometer/IUPC and the EUM in the beginning, end, peak and duration of each contraction. A good correlation will be 0.9 and significance of 95%.
100 women will be recruited to the study. The measurement with the EUM100pro will not interfere with the usual clinical care, meaning- the EUM100pro will be used in addition to the standard care and monitoring.
- Conditions
- Pregnancy
- Keywords
- Pregnancy, Term, Preterm, Uterine Contractions
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
The study primary outcome is to demonstrate that the EUM100pro uterine contractions measurements is as good as the current methods for monitoring pregnancy in labor (tocodynamometer, IUPC).
The primary outcome will be measured by correlation of timing of :peak display in beginning, during and end of peak in the EUM100pro versus the timing of the peak display in beginning, during and the end tocodynamometer and or IUPC peak.
Measured: two years
To evaluate patient safety
Measurements of device related adverse events throughout the study.
Measured: one year
Secondary outcomes (3)
Correlation of uterine contractions intensity between EUM100pro and Intra Uterine Pressure Catheter measurements.
The secondary outcome will investigate a correlation between the intensity/peak of contraction of mechanical contraction as measured by Intra Uterine pressure catheter and the intensity/peak of contraction of electrical activity as measured by the EUM exists.
Measured: one year
To evaluate usability of the EUM100pro
Measured: one year
to evaluate whether a fetal ECG can be exctraced from the electrical signal of the uterus.
The electrical signal recorded from the abdomen thechnically contain the uterine muscle electrical activity but also the electrical signal from the fetal ecg.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2012 (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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OB-Tools Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tal Shental Biron, MD, Principal investigator, Meir Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165879
- Sponsor's protocol ID
- HTA5347
- Status last verified
- Jul 2010
- First submitted
- 18 Jul 2010
- Last updated
- 10 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Uterine Electrical Activity Throughout Pregnancy and Labor Measuring Uterine Electrical Activity Throughout Pregnancy and Labor
- ClinicalTrials.gov ID
- NCT01165879
- Acronym / sponsor ID
- HTA5347
- Conditions
- Pregnancy
- Keywords
- Pregnancy, Term, Preterm, Uterine Contractions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- OB-Tools Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- May 2012 (estimated)
- First posted
- 20 Jul 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.
The EUM100pro (Electrical Uterine Monitor)is a uterine contraction monitor which measures uterine contractions based on the electrical activity of the uterine muscle.The study will compare the EUM100pro measurements to the already existing uterine contractions monitors (tocodynamometer and Intra Uterine Pressure Catheter) in pregnant women with complaints of uterine contractions.
Detailed description
The main objective of the study is to demonstrate that the EUM100pro is as good as the current methods for monitoring pregnancy in labor (tocodynamometer, IUPC) in measuring uterine contractions. This will be performed by measuring the expectancy of time differences between the tocodynamometer/IUPC and the EUM in the beginning, end, peak and duration of each contraction. A good correlation will be 0.9 and significance of 95%.
100 women will be recruited to the study. The measurement with the EUM100pro will not interfere with the usual clinical care, meaning- the EUM100pro will be used in addition to the standard care and monitoring.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pergnant women which are admitted to Meir Medical Center with complaints of uterine contractions starting.
Key inclusion criteria (4 listed)
- Women at term with complaint of uterine contractions at Meir Medical Center
- Women at preterm with complaint of uterine contractions at Meir Medical Center.
- Women at gestational age >24 weeks
- Subjects who understood, agreed and signed the informed consent form
Key exclusion criteria (5 listed)
- Subjects who refused to sign the informed consent form
- Abnormal fetal heart rate recording at admittance
- Subjects with indications for immediate delivery
- Subjects younger than 18 years of age
- Subjects at gestational age <24 weeks
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
The study primary outcome is to demonstrate that the EUM100pro uterine contractions measurements is as good as the current methods for monitoring pregnancy in labor (tocodynamometer, IUPC).
Time frame: two years
The primary outcome will be measured by correlation of timing of :peak display in beginning, during and end of peak in the EUM100pro versus the timing of the peak display in beginning, during and the end tocodynamometer and or IUPC peak.
To evaluate patient safety
Time frame: one year
Measurements of device related adverse events throughout the study.
3 secondary outcomes
Correlation of uterine contractions intensity between EUM100pro and Intra Uterine Pressure Catheter measurements.
Time frame: one year
To evaluate usability of the EUM100pro
Time frame: one year
to evaluate whether a fetal ECG can be exctraced from the electrical signal of the uterus.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 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.
Tal Shental Biron, MD principal investigator
Meir 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 Pregnancy, run by OB-Tools 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 5 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 10 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 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 Tal Shental Biron, MD (972-577482716, Tal.Biron-Shental@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The study primary outcome is to demonstrate that the EUM100pro uterine contractions measurements is as good as the current methods for monitoring pregnancy in labor (tocodynamometer, IUPC). (time frame: two years). The study lists 2 primary outcomes in all. 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 10 Jun 2011.