Fetal Heartbeat TracingsPhase 3NCT02875418
Comparing Two Methods of Contractions Monitoring for Clinical Decision Making Regarding Treatment Among Pregnant Women With Preterm Contractions.
A Phase 3 study testing EUM and Tocodynamometry in people with Fetal Heartbeat Tracings, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Background: Identification and measurement of uterine contractions throughout pregnancy and labor is crucial to the well being of both mother and fetus. Prematurity is one of the major causes for adverse pregnancy outcomes, and clinical decision-making often relies on uterine frequency as recorded by a… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Heartbeat Tracings
- What is being tested?
- EUM and Tocodynamometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Sep 2019
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gestational age 24+0/7 to 33+6/7 weeks of gestation.
- Maternal age > 18 years.
- Contractions, cramping, pelvic pressure or backache.
- Reactive fetal heart rate monitoring at enrollment.
- Subjects are willing and able to comply with the requirements of the protocol.
- Fully understand all elements of the study, and have signed and dated, the written informed consent form before initiation of protocol-specified procedures.
Who cannot join
- Refusal to participate.
- Maternal age < 18 years.
- Woman with implanted electronic device of any kind.
- Woman with allergy to silver.
- Irritated skin or open wound.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Study Aimed at Comparing Two Methods of Contractions Monitoring (Electrical Uterine Monitor - EUM vs. Tocodynamometer) for Clinical Decision Making Regarding Treatment Among Pregnant Women With Preterm Contractions.
Background:
Identification and measurement of uterine contractions throughout pregnancy and labor is crucial to the well being of both mother and fetus. Prematurity is one of the major causes for adverse pregnancy outcomes, and clinical decision-making often relies on uterine frequency as recorded by a tocodynamometer, as well as on other methods including sonographic cervical length, pelvic examination.
Objective:
To show that the use of the EUM in preterm labor is effective in establishing true preterm labor.
Read the detailed description
Methods:
Currently, three methods of assessing uterine activity exist. The first, tocodynamometry, is based on mechanical measurement of abdominal wall stiffness by a strain gauge placed externally on the patient's abdomen. This method mainly displays the presence of a contraction, its duration and the frequency of contractions. Yet, it fails to reflect the actual quantity of baseline tone or contraction amplitude due to great variability in placement and the gravida's body habitus. It is also unable to distinguish between true contractions or maternal movements or maternal Valsalva maneuver such as in coughing, straining or sneezing. These are the main reasons this technology is known to be unreliable in many cases and shows high percentage of false positive and false negative results [1].
Another method for monitoring uterine contractions is an internal measurement of uterine pressure via an Intra-Uterine Pressure Catheter (IUPC). While it is accurate in recording intensity, duration and frequency of contractions, as well as uterine basal tone, it has two principle limitations: the IUPC can only be used after rupture of the membranes, and the introduction of a foreign object in the uterine cavity may result in chorioamnionitis.
The third method of evaluating uterine activity involves recording of the myometrial electrical activity [2]. Initially, this was assessed in animal models by means of invasive uterine EMG [3-6], followed by noninvasive EMG recordings from abdominal surface in humans [7-10]. Several studies have attempted to correlate between term and preterm labor to uterine EMG, with limited success [11-17]. However, although most traditional EMG devices use only 2 electrodes, a multichannel, noninvasive EMG device have been used successfully in previous studies, both in preterm and term pregnancies, and were proved as both safe and accurate [18-25]. Recently, reliability studies were published, regarding the comparison to tocodynamomtery, IUPC and electrical uterine monitoring, using a multichannel EMG, and demonstrated the multichannel EMG is as good as the IUPC ('Gold Standard') and both multichannel EMG and IUPC are superior to tocodynamometry in recording uterine activity [26-27].
Study rational Premature labor and delivery heralds great costs to the healthcare system, including admission costs, tocolytic treatment and side effects and neonatal treatment of the preterm neonate. Unfortunately, the accuracy of diagnosing preterm labor is poor, with less than 10% of women presenting with preterm labor symptoms actually delivering within 7 days of symptoms' onset [28], 30% with resolving symptoms and more than 50% delivering at term [29]. Since IUPC cannot be used in women with intact membranes and tocodynamometry is unreliable, with previous reports concluding that multichannel EMG is superior to tocodynamomtery and comparable to IUPC, our objective is to evaluate the utility of the multichannel EMG in women with preterm contractions.
- Conditions
- Fetal Heartbeat Tracings
- Being tested
- EUM, Tocodynamometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUMDevice
STUDY DESIGN
- Explanation regarding the study and assessing eligibility criteria.
- Signing an informed consent.
- Recording of uterine contractions by both EUM and tocodynamometry. A correlation between EUM and tocodynamometry will be calculated. For the purpose of this study, a positive EUM or tocodynamometry will be defined as 3 at least 3 contractions in 30 minutes.
TocodynamometryDevice
STUDY DESIGN
- Explanation regarding the study and assessing eligibility criteria.
- Signing an informed consent.
- Recording of uterine contractions by both EUM and tocodynamometry. A correlation between EUM and tocodynamometry will be calculated. For the purpose of this study, a positive EUM or tocodynamometry will be defined as 3 at least 3 contractions in 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| EUM and tocodynamometry | Experimental | Pregnant women with gestational age 24+0/7 to 33+6/7 weeks of gestation and contractions, cramping, pelvic pressure or backache. Receives: Device: EUM; Device: Tocodynamometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of preterm deliveries
Week of gestation will be documented.
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Heartbeat TracingsStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- yariv yogev, professor, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875418
- Sponsor's protocol ID
- 171-16-TLV
- Status last verified
- Aug 2016
- First submitted
- 18 Aug 2016
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Aimed at Comparing Two Methods of Contractions Monitoring (Electrical Uterine Monitor - EUM vs. Tocodynamometer) for Clinical Decision Making Regarding Treatment Among Pregnant Women With Preterm Contractions.
- ClinicalTrials.gov ID
- NCT02875418
- Acronym / sponsor ID
- 171-16-TLV
- Conditions
- Fetal Heartbeat Tracings
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Sep 2016
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 23 Aug 2016 (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.
Background:
Identification and measurement of uterine contractions throughout pregnancy and labor is crucial to the well being of both mother and fetus. Prematurity is one of the major causes for adverse pregnancy outcomes, and clinical decision-making often relies on uterine frequency as recorded by a tocodynamometer, as well as on other methods including sonographic cervical length, pelvic examination.
Objective:
To show that the use of the EUM in preterm labor is effective in establishing true preterm labor.
Detailed description
Methods:
Currently, three methods of assessing uterine activity exist. The first, tocodynamometry, is based on mechanical measurement of abdominal wall stiffness by a strain gauge placed externally on the patient's abdomen. This method mainly displays the presence of a contraction, its duration and the frequency of contractions. Yet, it fails to reflect the actual quantity of baseline tone or contraction amplitude due to great variability in placement and the gravida's body habitus. It is also unable to distinguish between true contractions or maternal movements or maternal Valsalva maneuver such as in coughing, straining or sneezing. These are the main reasons this technology is known to be unreliable in many cases and shows high percentage of false positive and false negative results [1].
Another method for monitoring uterine contractions is an internal measurement of uterine pressure via an Intra-Uterine Pressure Catheter (IUPC). While it is accurate in recording intensity, duration and frequency of contractions, as well as uterine basal tone, it has two principle limitations: the IUPC can only be used after rupture of the membranes, and the introduction of a foreign object in the uterine cavity may result in chorioamnionitis.
The third method of evaluating uterine activity involves recording of the myometrial electrical activity [2]. Initially, this was assessed in animal models by means of invasive uterine EMG [3-6], followed by noninvasive EMG recordings from abdominal surface in humans [7-10]. Several studies have attempted to correlate between term and preterm labor to uterine EMG, with limited success [11-17]. However, although most traditional EMG devices use only 2 electrodes, a multichannel, noninvasive EMG device have been used successfully in previous studies, both in preterm and term pregnancies, and were proved as both safe and accurate [18-25]. Recently, reliability studies were published, regarding the comparison to tocodynamomtery, IUPC and electrical uterine monitoring, using a multichannel EMG, and demonstrated the multichannel EMG is as good as the IUPC ('Gold Standard') and both multichannel EMG and IUPC are superior to tocodynamometry in recording uterine activity [26-27].
Study rational Premature labor and delivery heralds great costs to the healthcare system, including admission costs, tocolytic treatment and side effects and neonatal treatment of the preterm neonate. Unfortunately, the accuracy of diagnosing preterm labor is poor, with less than 10% of women presenting with preterm labor symptoms actually delivering within 7 days of symptoms' onset [28], 30% with resolving symptoms and more than 50% delivering at term [29]. Since IUPC cannot be used in women with intact membranes and tocodynamometry is unreliable, with previous reports concluding that multichannel EMG is superior to tocodynamomtery and comparable to IUPC, our objective is to evaluate the utility of the multichannel EMG in women with preterm contractions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EUM and tocodynamometry | Experimental | Device: EUM, Device: TocodynamometryPregnant women with gestational age 24+0/7 to 33+6/7 weeks of gestation and contractions, cramping, pelvic pressure or backache. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Gestational age 24+0/7 to 33+6/7 weeks of gestation.
- Maternal age > 18 years.
- Contractions, cramping, pelvic pressure or backache.
- Reactive fetal heart rate monitoring at enrollment.
- Subjects are willing and able to comply with the requirements of the protocol.
Key exclusion criteria (5 listed)
- Refusal to participate.
- Maternal age < 18 years.
- Woman with implanted electronic device of any kind.
- Woman with allergy to silver.
- Irritated skin or open wound.
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 |
|---|---|---|
| EUMSTUDY DESIGN 1. Explanation regarding the study and assessing eligibility criteria. 2. Signing an informed consent. 3. Recording of uterine contractions by both EUM and tocodynamometry. A correlation between EUM and tocodynamometry will be calculated. For the purpose of this study, a positive EUM or tocodynamometry will be defined as 3 at least 3 contractions in 30 minutes. | Device | EUM and tocodynamometry |
| TocodynamometrySTUDY DESIGN 1. Explanation regarding the study and assessing eligibility criteria. 2. Signing an informed consent. 3. Recording of uterine contractions by both EUM and tocodynamometry. A correlation between EUM and tocodynamometry will be calculated. For the purpose of this study, a positive EUM or tocodynamometry will be defined as 3 at least 3 contractions in 30 minutes. | Device | EUM and tocodynamometry |
Primary outcome
Rate of preterm deliveries
Time frame: 4 month
Week of gestation will be documented.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2016.
- Individual participant dataSharing planned: No
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.
yariv yogev, professor principal investigator
Tel Aviv Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EUM and Tocodynamometry in people with Fetal Heartbeat Tracings, run by Tel-Aviv Sourasky Medical Center.
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 6 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 23 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 yariv yogev, professor (97236925603, yarivy@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of preterm deliveries (time frame: 4 month). 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 Aug 2016.