PregnancyNCT01730963
Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring and Nonlaboring Patients by Practicing Clinicians
An observational study of Pregnancy, run by Reproductive Research Technologies, LP at 5 sites in United States.
Trial summary
This multi-reader multi-case study was designed to evaluate the performance of SureCALL® Labor Monitor® (SureCALL®) directly to the standard Tocodynamometer device (TOCO). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pregnancy
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2007to Sep 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women with uncomplicated singleton pregnancies
Who may be able to join
- Singleton Pregnancy
- Informed Consent Required
Who cannot join
- Multifetal Pregnancy
- Informed Consent Not Given
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Southeast Texas OB/GYN Associates
Beaumont, Texas, 77702
University of Texas Medical Branch
Galveston, Texas, 77555
Woman's Hospital of Texas
Houston, Texas, 77054
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19101
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
About this study
This multi-reader multi-case study was designed to evaluate the performance of SureCALL® Labor Monitor® (SureCALL®) directly to the standard Tocodynamometer device (TOCO).
Read the detailed description
The SureCALL® Labor Monitor® (SureCALL®) is a transabdominal electromyography monitor intended to measure uterine activity. It is intended for use on pregnant women, with singleton pregnancies, using surface electrodes on the maternal abdomen. The device is intended for use by healthcare professionals in a clinical setting.
This multi-reader multi-case study was designed to evaluate the performance of SureCALL® to the predicate Tocodynamometer device (TOCO).
This study involved 25 women at a Gestational Age of 36 weeks or less and 5 women at a Gestation Age of greater than 36 and not in labor at five clinical sites. Each study subject was instrumented with two technologies for measuring uterine activity:
- Standard tocodynamometer attached to the maternal abdomen,
- SureCALL® with a set of abdominal surface electrodes for uterine electromyography attached to the maternal abdomen
An assessment was obtained and quantified from masked, qualified clinical obstetrician readers for the evaluation of the equivalence of both labor monitor devices by identifying in isolation the individual uterine contraction signals and the peak of each contraction signal as recorded by each labor monitor device.
- Conditions
- Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant, Preterm, In Labor | Gestation Age at or less than 36 weeks, clinically determined to be in labor | |
| Pregnant, Preterm, Nonlaboring | Gestation Age at or less than 36 weeks, clinically determined to not be in labor | |
| Pregnant, Term, Nonlaboring | Gestation Age more than 36 weeks, clinically determined to not be in labor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of SureCALL® and Tocodynamometer Detection of Contraction Events, as Identified by Readers
Agreement will be assessed by coefficient of individual agreement (CIA) derived from a dataset of all Reader-marked contractions. In addition, sensitivity and false positive rate per hours will be estimated for each patient by each reader. If CIA ≥ 0.445 (Barnhart, 2007, section 3) or CIA>0.8, Pan 2010), the SureCALL® is not significantly different than the TOCO.
Measured: 9 - 41 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startJan 2007
- Primary completionDec 2011
- Study completionSep 2012
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 only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Research Technologies, LP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy B Waterhouse, MD, Study director, Reproductive Research Technologies, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730963
- Sponsor's protocol ID
- RRT-12-01
- Status last verified
- Nov 2012
- First submitted
- 15 Nov 2012
- Last updated
- 22 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring and Nonlaboring Patients by Practicing Clinicians
- ClinicalTrials.gov ID
- NCT01730963
- Acronym / sponsor ID
- RRT-12-01
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Reproductive Research Technologies, LPIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 21 Nov 2012 (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.
This multi-reader multi-case study was designed to evaluate the performance of SureCALL® Labor Monitor® (SureCALL®) directly to the standard Tocodynamometer device (TOCO).
Detailed description
The SureCALL® Labor Monitor® (SureCALL®) is a transabdominal electromyography monitor intended to measure uterine activity. It is intended for use on pregnant women, with singleton pregnancies, using surface electrodes on the maternal abdomen. The device is intended for use by healthcare professionals in a clinical setting.
This multi-reader multi-case study was designed to evaluate the performance of SureCALL® to the predicate Tocodynamometer device (TOCO).
This study involved 25 women at a Gestational Age of 36 weeks or less and 5 women at a Gestation Age of greater than 36 and not in labor at five clinical sites. Each study subject was instrumented with two technologies for measuring uterine activity:
- Standard tocodynamometer attached to the maternal abdomen,
- SureCALL® with a set of abdominal surface electrodes for uterine electromyography attached to the maternal abdomen
An assessment was obtained and quantified from masked, qualified clinical obstetrician readers for the evaluation of the equivalence of both labor monitor devices by identifying in isolation the individual uterine contraction signals and the peak of each contraction signal as recorded by each labor monitor device.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pregnant, Preterm, In Labor | – | –Gestation Age at or less than 36 weeks, clinically determined to be in labor |
| Pregnant, Preterm, Nonlaboring | – | –Gestation Age at or less than 36 weeks, clinically determined to not be in labor |
| Pregnant, Term, Nonlaboring | – | –Gestation Age more than 36 weeks, clinically determined to not be in labor |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women with uncomplicated singleton pregnancies
Key inclusion criteria (2 listed)
- Singleton Pregnancy
- Informed Consent Required
Key exclusion criteria (2 listed)
- Multifetal Pregnancy
- Informed Consent Not Given
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
Comparison of SureCALL® and Tocodynamometer Detection of Contraction Events, as Identified by Readers
Time frame: 9 - 41 Minutes
Agreement will be assessed by coefficient of individual agreement (CIA) derived from a dataset of all Reader-marked contractions. In addition, sensitivity and false positive rate per hours will be estimated for each patient by each reader. If CIA ≥ 0.445 (Barnhart, 2007, section 3) or CIA>0.8, Pan 2010), the SureCALL® is not significantly different than the TOCO.
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 22 Nov 2012.
Related trials for Pregnancy
Active, not recruitingObservational study
A Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns and Outcomes in Atypical Hemolytic Uremic Syndrome Patients
Atypical Hemolytic Uremic Syndrome(aHUS)
Recruiting
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Neonatal Respiratory Distress Related Conditions, Meconium
Recruiting
Feasibility of the "One-Finger Technique" for Identifying the Upper Left Ureter During Para-Aortic Lymphadenectomy
Ovary Cancer, Cervical Cancer
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
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.
Timothy B Waterhouse, MD study director
Reproductive Research Technologies, LP
5 sites 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 Reproductive Research Technologies, LP at 5 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 2 inclusion and 2 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 22 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Comparison of SureCALL® and Tocodynamometer Detection of Contraction Events, as Identified by Readers (time frame: 9 - 41 Minutes). 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 22 Nov 2012.