Pregnancy RelatedNoviiNCT03156608
Novii External Fetal Monitoring Device
A study testing Novii ECG/EKG System and External fetal heart rate monitoring in people with Pregnancy Related and Fetal Distress, run by Intermountain Health Care, Inc. at 4 sites in United States.
Trial summary
This study will be conducted on women in labor. Fetal heart rate monitoring will be conducting using the Novii Fetal ECG/EMG system and comparing it to current standard of care external fetal heart rate and tocometry. 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
- Pregnancy Related, Fetal Distress
- What is being tested?
- Novii ECG/EKG System and External fetal heart rate monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 4 sitesUnited States
- Study dates
- 6 Mar 2017to 28 Jun 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women ≥ 18 years of age; gestational age ≥ 37 weeks
- Singleton pregnancy.
- These women will be those presenting to Labor and Delivery for one of the following:
- Rule out labor
- Spontaneous labor
- Induction of labor
Who cannot join
- Age < 18 years old; multiple gestation pregnancy; gestational age < 37 weeks
- Fetal distress or vaginal bleeding prior to monitor placement
- Previous cesarean section
- Planned cesarean delivery.
- Women who are enrolled in the study but have less than 1 hour of fetal heart rate monitoring after randomization will be excluded from analysis.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Intermountain Medical Center
Murray, Utah, 84107
McKay-Dee Hospital
Ogden, Utah, 84403
Utah Valley Hospital
Provo, Utah, 84604
LDS Hospital
Salt Lake City, Utah, 84143
About this study
Official title: Evaluation of the Novii External Fetal Monitoring Device: A Prospective, Randomized Comparison
This study will be conducted on women in labor. Fetal heart rate monitoring will be conducting using the Novii Fetal ECG/EMG system and comparing it to current standard of care external fetal heart rate and tocometry. These approaches will be compared with the respect to need for additional monitoring, amount of nursing intervention, cost and satisfaction of patients and healthcare providers.
Read the detailed description
Interpretation of fetal heart rate monitoring during labor is one of the most common procedures performed in the practice of obstetrics. Continuous monitoring of the fetal heart rate is used to identify infants at risk for hypoxic ischemic encephalopathy and allow for intervention to prevent this terrible complication. The quality of the fetal heart rate signal is critical for appropriate interpretation of the characteristics that identify risk.
This is a prospective, randomized pragmatic trial comparing the Novii Fetal ECG/EMG system to external fetal heart rate and tocometry (standard of care) for the amount of time of interpretable fetal heart rate during labor. Randomization will occur in blocks based on BMI to control for the potential effect of BMI.
Fetal heart rate tracings from both groups of women will be reviewed in a blinded fashion by experienced Maternal Fetal Medicine (MFM) physicians who will assess the tracing for quality and interpretability. In addition, both approaches will be compared with respect to the need for additional monitoring modalities, amount of nursing intervention, cost and satisfaction of the patients and healthcare providers.
- Conditions
- Pregnancy Related, Fetal Distress
- Being tested
- Novii ECG/EKG System, External fetal heart rate monitoring
- Keywords
- External Fetal Heart Rate Monitor, Fetal Heart Rate Monitor
- Medical subject headings
- Fetal Distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novii ECG/EKG SystemDevice
External fetal heart rate monitoring
External fetal heart rate monitoringDevice
External fetal heart rate monitoring
| Study group | Role | What they receive |
|---|---|---|
| Novii Device ECG/EMG System | Experimental | These patients will have the Novii ECG/EMG system placed throughout labor and delivery, unless a provider or investigator determines that a different device (internal or external) is necessary for a better signal. Receives: Device: Novii ECG/EKG System |
| Standard of Care External Monitor | Active comparator | A standard external monitor will be placed throughout labor and delivery, unless a provider or investigator determines that an internal device is necessary for a better signal. Receives: Device: External fetal heart rate monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of time in minutes with the interpretable fetal heart rate tracing during the course of labor.
Quality of the fetal heart rate for each minute of tracing will be assessed visually by 2 or more blinded reviewers. For the purpose of this study, uninterpretable fetal heart rate will be defined as continuous fetal heart rate data with one or more of the following:
- Data is missing for more than 75% of the minute of tracing
- Artifact is present for more than 25% of the minute of tracing
- Missing data or artifact prevents determination of baseline rate
- > 15 seconds of continuous missing tracing
- Missing data is not continuous but is sufficiently frequent that the one minute segment of tracing could not be used to determine baseline rate
The total number of interpretable minutes of fetal heart tracing and the percentage of time with interpretable fetal heart tracing over the course of labor (Number of minutes with interpretable FHR/Total number of minutes in labor) will be calculated for each patient.
Measured: Time of randomization until time of delivery (up to 48 hours)
Secondary outcomes (29)
Quality and interpretability of the FHT in ten minute segments
- Each 10 minute segment will be deemed to be interpretable if it meets all of the following criteria: i. Sufficient data are available to determine a baseline ii. Sufficient data are available to determine the variability of the tracing iii. Sufficient data are available to identify periodic changes in the tracing (e.g. accelerations, decelerations, etc) b. For each 10 minute segment that is called Uninterpretable, the reviewer will indicate the reason for this designation by selecting one of the following options: i. Poor signal quality due to missing data ii. Poor signal quality due to artifact iii. Adequate signal quality but intrinsic fetal heart rate makes interpretation impossible (e.g. marked variability, etc.)
Measured: Time of randomization until time of delivery (up to 48 hours)
Number and quality of uterine contractions in each 10 minute segment:
The number of uterine contractions per segment will be recorded b. Signal quality (amount of missing data or artifact) will be recorded
Measured: Time of randomization until time of delivery (up to 48 hours)
Number and quality of uterine contractions in each 10 minute segment:
Signal quality (amount of missing data or artifact) will be recorded
Measured: Time of randomization until time of delivery (up to 48 hours)
Number of times fetal heart rate monitor requires adjusting:
Measured by recording the number of times the nurse must adjust the monitoring system to obtain interpretable tracing
Measured: Time of randomization until time of delivery (up to 48 hours)
Number of times fetal heart rate monitor requires adjusting:
Number of times that hand holding of the monitor is required
Measured: Time of randomization until time of delivery (up to 48 hours)
Need for additional monitoring devices such as change from Novii to standard monitoring devices or the use of intrauterine pressure catheter or fetal scalp electrode:
Need for additional monitoring devices will be determined by the clinical care team including attending physician and/or nurses based on clinical judgment
Measured: Time of randomization until time of delivery (up to 48 hours)
Need for additional monitoring devices such as change from Novii to standard monitoring devices or the use of intrauterine pressure catheter or fetal scalp electrode will be recorded by clinical care team:
Reason 1: Poor signal quality - missing data Reason 2: Poor signal - artifact Reason 3: Need additional information (e.g. intrauterine pressure, etc.) Reason 4: Patient preference Reason 5: Provider preference
Measured: Time of randomization until time of delivery (up to 48 hours)
Need for additional monitoring devices such as change from Novii to standard monitoring devices or the use of intrauterine pressure catheter or fetal scalp electrode will be recorded by clinical care team:
Reason 2: Poor signal - artifact Reason 3: Need additional information (e.g. intrauterine pressure, etc.) Reason 4: Patient preference Reason 5: Provider preference
Measured: Time of randomization until time of delivery (up to 48 hours)
Need for additional monitoring devices such as change from Novii to standard monitoring devices or the use of intrauterine pressure catheter or fetal scalp electrode will be recorded by clinical care team:
Reason 3: Need additional information (e.g. intrauterine pressure, etc.) Reason 4: Patient preference Reason 5: Provider preference
Measured: Time of randomization until time of delivery (up to 48 hours)
Need for additional monitoring devices such as change from Novii to standard monitoring devices or the use of intrauterine pressure catheter or fetal scalp electrode will be recorded by clinical care team:
Reason 4: Patient preference Reason 5: Provider preference
Measured: Time of randomization until time of delivery (up to 48 hours)
Need for additional monitoring devices such as change from Novii to standard monitoring devices or the use of intrauterine pressure catheter or fetal scalp electrode will be recorded by clinical care team:
Reason 5: Provider preference
Measured: Time of randomization until time of delivery (up to 48 hours)
Nursing time required for care:
We will record the amount of time that the nurses spend at the bedside to adjust the monitor b. Nurses will record the time and reasons that they enter the room
Measured: Time of randomization until time of delivery (up to 48 hours)
Nursing time required for care:
Nurses will record the time and reasons that they enter the room
Measured: Time of randomization until time of delivery (up to 48 hours)
Overall cost of care:
Total charge for care from admission to Labor and Delivery to transfer to postpartum care will be recorded for all patients
Measured: Hospitalization for labor, delivery, and recovery - 2-4 days
Overall cost of care:
Delivery type and indication
Measured: Hospitalization for labor, delivery, and recovery - 2-4 days
Maternal outcomes - Length of labor
Length of labor recorded
Measured: Hospitalization for labor, delivery, and recovery - 2-4 days
Maternal outcomes - Delivery type
Type of delivery recorded (e.g., vaginal, cesarean section, etc.)
Measured: Hospitalization for labor, delivery, and recovery - 2-4 days
Maternal outcomes - Indication for forceps/vacuum extraction or cesarean section, if performed
Clinical indication for forceps/vacuum extraction or cesarean section delivery
Measured: Hospitalization for labor, delivery, and recovery - 2-4 days
Maternal outcomes - Estimated blood loss
Amount of blood loss (cc) recorded
Measured: Hospitalization for labor, delivery, and recovery - 2-4 days
Maternal outcomes - Presence and severity of perineal lacerations
Lacerations and degree of laceration recorded
Measured: Hospitalization for labor, delivery, and recovery - 2-4 days
Maternal outcomes - Intra-amniotic infection (clinical chorioamnionitis or triple I)
Infections documented
Measured: Hospitalization for labor, delivery, and recovery - 2-4 days
Maternal outcomes - Presence of clinical endometritis
Endometritis diagnosis recorded
Measured: Hospitalization for labor, delivery, and recovery - 2-4 days
Neonatal outcomes - APGAR Scores
APGAR scores recorded at 1 minute, 5 minutes, and 10 minutes
Measured: Hospitalization after delivery - 2-4 days
Neonatal outcomes - Need for ICU Admission
Recorded NICU admission
Measured: Hospitalization after delivery - 2-4 days
Neonatal outcomes - Birthweight
Infant birthweight (grams)
Measured: Hospitalization after delivery - 2-4 days
Neonatal outcomes - Neonatal Sex
Neonatal sex recorded
Measured: Hospitalization after delivery - 2-4 days
Patient and provider satisfaction - Patient Survey
Satisfaction survey completed by patient after delivery of infant
Measured: Up to 7 days after delivery
Patient and provider satisfaction - Nurse Survey
Satisfaction survey completed by nurse attending labor/delivery after delivery of infant
Measured: Up to 7 days after delivery
Patient and provider satisfaction - Attending Physician/Midwife Survey
Satisfaction survey completed by physician/midwife attending labor/delivery after delivery of infant
Measured: Up to 7 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start6 Mar 2017
- Primary completion28 Jun 2017
- Study completion28 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Women will be randomized to either standard monitoring with external Doppler and tocodynamometer or monitoring with the Novii Fetal ECG/EMG system using a computer generated randomization scheme through REDCap. Randomization will occur in blocks based on the subject's BMI. Women with a BMI \< 30 will be randomized separate from women with a BMI \> 30.
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Principal investigator, Michael Sean Esplin, Intermountain Health Care, Inc.
- Investigators
- Michael S Esplin, MD, Principal investigator, Staff Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156608
- Sponsor's protocol ID
- 1050411
- Acronym
- Novii
- Status last verified
- Oct 2017
- First submitted
- 14 Mar 2017
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Bakker PC, Colenbrander GJ, Verstraeten AA, Van Geijn HP. The quality of intrapartum fetal heart rate monitoring. Eur J Obstet Gynecol Reprod Biol. 2004 Sep 10;116(1):22-7. doi: 10.1016/j.ejogrb.2004.01.001.
PubMed 15294362Cohen WR, Ommani S, Hassan S, Mirza FG, Solomon M, Brown R, Schifrin BS, Himsworth JM, Hayes-Gill BR. Accuracy and reliability of fetal heart rate monitoring using maternal abdominal surface electrodes. Acta Obstet Gynecol Scand. 2012 Nov;91(11):1306-13. doi: 10.1111/j.1600-0412.2012.01533.x. Epub 2012 Oct 19.
PubMed 22924738Cohen WR, Hayes-Gill B. Influence of maternal body mass index on accuracy and reliability of external fetal monitoring techniques. Acta Obstet Gynecol Scand. 2014 Jun;93(6):590-5. doi: 10.1111/aogs.12387. Epub 2014 Apr 30.
PubMed 24684703Dawes GS, Visser GH, Goodman JD, Redman CW. Numerical analysis of the human fetal heart rate: the quality of ultrasound records. Am J Obstet Gynecol. 1981 Sep 1;141(1):43-52. doi: 10.1016/0002-9378(81)90673-6.
PubMed 7270621Rooth G, Huch A, Huch R (1987) FIGO news: guidelines for the use of fetal monitoring. Int J Gynaecol Obstet 25:159-167
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Novii External Fetal Monitoring Device: A Prospective, Randomized Comparison
- ClinicalTrials.gov ID
- NCT03156608
- Acronym / sponsor ID
- Novii / 1050411
- Conditions
- Pregnancy Related, Fetal Distress
- Keywords
- External Fetal Heart Rate Monitor, Fetal Heart Rate Monitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- GE Healthcare
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 28 Jun 2017 (actual)
- Study completion
- 28 Jun 2017 (actual)
- First posted
- 17 May 2017 (actual)
- 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.
This study will be conducted on women in labor. Fetal heart rate monitoring will be conducting using the Novii Fetal ECG/EMG system and comparing it to current standard of care external fetal heart rate and tocometry. These approaches will be compared with the respect to need for additional monitoring, amount of nursing intervention, cost and satisfaction of patients and healthcare providers.
Detailed description
Interpretation of fetal heart rate monitoring during labor is one of the most common procedures performed in the practice of obstetrics. Continuous monitoring of the fetal heart rate is used to identify infants at risk for hypoxic ischemic encephalopathy and allow for intervention to prevent this terrible complication. The quality of the fetal heart rate signal is critical for appropriate interpretation of the characteristics that identify risk.
This is a prospective, randomized pragmatic trial comparing the Novii Fetal ECG/EMG system to external fetal heart rate and tocometry (standard of care) for the amount of time of interpretable fetal heart rate during labor. Randomization will occur in blocks based on BMI to control for the potential effect of BMI.
Fetal heart rate tracings from both groups of women will be reviewed in a blinded fashion by experienced Maternal Fetal Medicine (MFM) physicians who will assess the tracing for quality and interpretability. In addition, both approaches will be compared with respect to the need for additional monitoring modalities, amount of nursing intervention, cost and satisfaction of the patients and healthcare providers.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Women will be randomized to either standard monitoring with external Doppler and tocodynamometer or monitoring with the Novii Fetal ECG/EMG system using a computer generated randomization scheme through REDCap. Randomization will occur in blocks based on the subject's BMI. Women with a BMI < 30 will be randomized separate from women with a BMI > 30.
| Arm | Type | Receives |
|---|---|---|
| Novii Device ECG/EMG System | Experimental | Device: Novii ECG/EKG SystemThese patients will have the Novii ECG/EMG system placed throughout labor and delivery, unless a provider or investigator determines that a different device (internal or external) is necessary for a better signal. |
| Standard of Care External Monitor | Active comparator | Device: External fetal heart rate monitoringA standard external monitor will be placed throughout labor and delivery, unless a provider or investigator determines that an internal device is necessary for a better signal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pregnant women ≥ 18 years of age; gestational age ≥ 37 weeks
- Singleton pregnancy.
- These women will be those presenting to Labor and Delivery for one of the following:
Key exclusion criteria (5 listed)
- Age < 18 years old; multiple gestation pregnancy; gestational age < 37 weeks
- Fetal distress or vaginal bleeding prior to monitor placement
- Previous cesarean section
- Planned cesarean delivery.
- Women who are enrolled in the study but have less than 1 hour of fetal heart rate monitoring after randomization will be excluded from analysis.
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 |
|---|---|---|
| Novii ECG/EKG SystemExternal fetal heart rate monitoring | Device | Novii Device ECG/EMG System |
| External fetal heart rate monitoringExternal fetal heart rate monitoring | Device | Standard of Care External Monitor |
Primary outcome
Amount of time in minutes with the interpretable fetal heart rate tracing during the course of labor.
Time frame: Time of randomization until time of delivery (up to 48 hours)
Quality of the fetal heart rate for each minute of tracing will be assessed visually by 2 or more blinded reviewers. For the purpose of this study, uninterpretable fetal heart rate will be defined as continuous fetal heart rate data with one or more of the following: 1. Data is missing for more than 75% of the minute of tracing 2. Artifact is present for more than 25% of the minute of tracing 3. Missing data or artifact prevents determination of baseline rate 1. > 15 seconds of continuous missing tracing 2. Missing data is not continuous but is sufficiently frequent that the one minute segment of tracing could not be used to determine baseline rate The total number of interpretable minutes of fetal heart tracing and the percentage of time with interpretable fetal heart tracing over the course of labor (Number of minutes with interpretable FHR/Total number of minutes in labor) will be calculated for each patient.
29 secondary outcomes
Quality and interpretability of the FHT in ten minute segments
Time frame: Time of randomization until time of delivery (up to 48 hours)
Number and quality of uterine contractions in each 10 minute segment:
Time frame: Time of randomization until time of delivery (up to 48 hours)
Number and quality of uterine contractions in each 10 minute segment:
Time frame: Time of randomization until time of delivery (up to 48 hours)
Number of times fetal heart rate monitor requires adjusting:
Time frame: Time of randomization until time of delivery (up to 48 hours)
Number of times fetal heart rate monitor requires adjusting:
Time frame: Time of randomization until time of delivery (up to 48 hours)
Need for additional monitoring devices such as change from Novii to standard monitoring devices or the use of intrauterine pressure catheter or fetal scalp electrode:
Time frame: Time of randomization until time of delivery (up to 48 hours)
Need for additional monitoring devices such as change from Novii to standard monitoring devices or the use of intrauterine pressure catheter or fetal scalp electrode will be recorded by clinical care team:
Time frame: Time of randomization until time of delivery (up to 48 hours)
Need for additional monitoring devices such as change from Novii to standard monitoring devices or the use of intrauterine pressure catheter or fetal scalp electrode will be recorded by clinical care team:
Time frame: Time of randomization until time of delivery (up to 48 hours)
Need for additional monitoring devices such as change from Novii to standard monitoring devices or the use of intrauterine pressure catheter or fetal scalp electrode will be recorded by clinical care team:
Time frame: Time of randomization until time of delivery (up to 48 hours)
Need for additional monitoring devices such as change from Novii to standard monitoring devices or the use of intrauterine pressure catheter or fetal scalp electrode will be recorded by clinical care team:
Time frame: Time of randomization until time of delivery (up to 48 hours)
Need for additional monitoring devices such as change from Novii to standard monitoring devices or the use of intrauterine pressure catheter or fetal scalp electrode will be recorded by clinical care team:
Time frame: Time of randomization until time of delivery (up to 48 hours)
Nursing time required for care:
Time frame: Time of randomization until time of delivery (up to 48 hours)
Nursing time required for care:
Time frame: Time of randomization until time of delivery (up to 48 hours)
Overall cost of care:
Time frame: Hospitalization for labor, delivery, and recovery - 2-4 days
Overall cost of care:
Time frame: Hospitalization for labor, delivery, and recovery - 2-4 days
Maternal outcomes - Length of labor
Time frame: Hospitalization for labor, delivery, and recovery - 2-4 days
Maternal outcomes - Delivery type
Time frame: Hospitalization for labor, delivery, and recovery - 2-4 days
Maternal outcomes - Indication for forceps/vacuum extraction or cesarean section, if performed
Time frame: Hospitalization for labor, delivery, and recovery - 2-4 days
Maternal outcomes - Estimated blood loss
Time frame: Hospitalization for labor, delivery, and recovery - 2-4 days
Maternal outcomes - Presence and severity of perineal lacerations
Time frame: Hospitalization for labor, delivery, and recovery - 2-4 days
Maternal outcomes - Intra-amniotic infection (clinical chorioamnionitis or triple I)
Time frame: Hospitalization for labor, delivery, and recovery - 2-4 days
Maternal outcomes - Presence of clinical endometritis
Time frame: Hospitalization for labor, delivery, and recovery - 2-4 days
Neonatal outcomes - APGAR Scores
Time frame: Hospitalization after delivery - 2-4 days
Neonatal outcomes - Need for ICU Admission
Time frame: Hospitalization after delivery - 2-4 days
Neonatal outcomes - Birthweight
Time frame: Hospitalization after delivery - 2-4 days
Neonatal outcomes - Neonatal Sex
Time frame: Hospitalization after delivery - 2-4 days
Patient and provider satisfaction - Patient Survey
Time frame: Up to 7 days after delivery
Patient and provider satisfaction - Nurse Survey
Time frame: Up to 7 days after delivery
Patient and provider satisfaction - Attending Physician/Midwife Survey
Time frame: Up to 7 days after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
- Background: PubMed 15294362Bakker PC, Colenbrander GJ, Verstraeten AA, Van Geijn HP. The quality of intrapartum fetal heart rate monitoring. Eur J Obstet Gynecol Reprod Biol. 2004 Sep 10;116(1):22-7. doi: 10.1016/j.ejogrb.2004.01.001.
- Background: PubMed 22924738Cohen WR, Ommani S, Hassan S, Mirza FG, Solomon M, Brown R, Schifrin BS, Himsworth JM, Hayes-Gill BR. Accuracy and reliability of fetal heart rate monitoring using maternal abdominal surface electrodes. Acta Obstet Gynecol Scand. 2012 Nov;91(11):1306-13. doi: 10.1111/j.1600-0412.2012.01533.x. Epub 2012 Oct 19.
- Background: PubMed 24684703Cohen WR, Hayes-Gill B. Influence of maternal body mass index on accuracy and reliability of external fetal monitoring techniques. Acta Obstet Gynecol Scand. 2014 Jun;93(6):590-5. doi: 10.1111/aogs.12387. Epub 2014 Apr 30.
- Background: PubMed 7270621Dawes GS, Visser GH, Goodman JD, Redman CW. Numerical analysis of the human fetal heart rate: the quality of ultrasound records. Am J Obstet Gynecol. 1981 Sep 1;141(1):43-52. doi: 10.1016/0002-9378(81)90673-6.
- BackgroundRooth G, Huch A, Huch R (1987) FIGO news: guidelines for the use of fetal monitoring. Int J Gynaecol Obstet 25:159-167
- Individual participant dataSharing planned: Undecided
Related trials for Pregnancy Related
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Not yet recruitingObservational study
Obesity-Related Indices and Albuminuria in Type 2 Diabetes
Obesity and Diabetes Mellitus, Type 2, Albuminuria
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Not yet recruiting
Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy
Methamphetamine Use Disorder, Pregnancy
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.
Michael S Esplin, MD principal investigator
Staff Physician
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novii ECG/EKG System and External fetal heart rate monitoring in people with Pregnancy Related and Fetal Distress, run by Intermountain Health Care, Inc. at 4 sites in United States.
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: finished, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Amount of time in minutes with the interpretable fetal heart rate tracing during the course of labor. (time frame: Time of randomization until time of delivery (up to 48 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03156608, which also lists 5 linked publications.
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 1 Nov 2017.