Pregnancy - Labor MonitoringNCT01282723
Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring Patients by Practicing Clinicians
An observational study of Pregnancy - Labor Monitoring, run by Reproductive Research Technologies, LP at 3 sites in United States.
Trial summary
This multi-reader multi-case study was designed to evaluate the performance of SureCALL® EMG Labor Monitor® (SureCALL®)to the predicate Tocodynamometer device (TOCO) using the performance of an Intrauterine Pressure Catheter device (IUPC) as the "gold standard". Read more about this study
- Who is it for?
- Ages 15 to 40 years, women only
- Conditions the study is for
- Pregnancy - Labor Monitoring
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2008to Jan 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Women in labor with uncomplicated singleton pregnancies and IUPC indicated with membranes ruptured and sufficient cervical dilation.
Who may be able to join
- Singleton Pregnancy
- Indicated for IUPC
- Gestational ages from 37 to 41 weeks
- Informed consent required
Who cannot join
- Multifetal pregnancy
- Not Indicated for IUPC
- Gestation age below 37 or above 41 weeks
- Informed consent not given
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Texas Medical Branch
Galveston, Texas, 77555
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
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® EMG Labor Monitor® (SureCALL®)to the predicate Tocodynamometer device (TOCO) using the performance of an Intrauterine Pressure Catheter device (IUPC) as the "gold standard".
Read the detailed description
The SureCALL® EMG Labor Monitor® (SureCALL®)is a transabdominal electromyography monitor intended to measure intrapartum uterine activity. It is intended for use on term pregnant women who are in labor, 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) using the performance of an Intrauterine Pressure Catheter device (IUPC) as the "gold standard".
This study involved 20 women at term, in labor, at three clinical sites. Each study subject was instrumented with three technologies for measuring uterine activity:
- a tocodynamometer attached to the maternal abdomen
- a set of abdominal surface electrodes for uterine electromyography, and
- an intrauterine pressure catheter.
An assessment was obtained and quantified from masked, qualified clinical obstetrician readers for the evaluation of the equivalence of the three independent labor monitor devices by identifying in isolation the individual uterine contraction signals and the peak of each contraction signal produced by a full-term patient in term labor as independently collected by each labor monitor device.
- Conditions
- Pregnancy - Labor Monitoring
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, In Labor | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC, as Identified by Readers
The presence of contractions measured by the SureCALL®, the presence of contractions measured by the TOCO, and the presence of contractions measured by the IUPC were determined by independent Readers. The Odds Ratio of SureCALL® contractions to IUPC contractions was calculated, and the Odd Ratio of TOCO contractions to IUPC contractions was calculated. Reader Correspondence was determined by a General Linear Mixed Model.
Measured: 9 - 42 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2011 (estimated)
- Study startAug 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pregnancy - Labor MonitoringStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Research Technologies, LP
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Timothy B Waterhouse, MD, Principal investigator, Reproductive Research Technologies, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282723
- Sponsor's protocol ID
- RRT-10-01
- Status last verified
- Feb 2011
- First submitted
- 21 Jan 2011
- Last updated
- 15 Mar 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2011. 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 Patients by Practicing Clinicians
- ClinicalTrials.gov ID
- NCT01282723
- Acronym / sponsor ID
- RRT-10-01
- Conditions
- Pregnancy - Labor Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Reproductive Research Technologies, LPIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 25 Jan 2011 (estimated)
- Results
- Posted 15 Mar 2011
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® EMG Labor Monitor® (SureCALL®)to the predicate Tocodynamometer device (TOCO) using the performance of an Intrauterine Pressure Catheter device (IUPC) as the "gold standard".
Detailed description
The SureCALL® EMG Labor Monitor® (SureCALL®)is a transabdominal electromyography monitor intended to measure intrapartum uterine activity. It is intended for use on term pregnant women who are in labor, 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) using the performance of an Intrauterine Pressure Catheter device (IUPC) as the "gold standard".
This study involved 20 women at term, in labor, at three clinical sites. Each study subject was instrumented with three technologies for measuring uterine activity:
- a tocodynamometer attached to the maternal abdomen
- a set of abdominal surface electrodes for uterine electromyography, and
- an intrauterine pressure catheter.
An assessment was obtained and quantified from masked, qualified clinical obstetrician readers for the evaluation of the equivalence of the three independent labor monitor devices by identifying in isolation the individual uterine contraction signals and the peak of each contraction signal produced by a full-term patient in term labor as independently collected by each labor monitor device.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant, In Labor | – | – |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Women in labor with uncomplicated singleton pregnancies and IUPC indicated with membranes ruptured and sufficient cervical dilation.
Key inclusion criteria (4 listed)
- Singleton Pregnancy
- Indicated for IUPC
- Gestational ages from 37 to 41 weeks
- Informed consent required
Key exclusion criteria (4 listed)
- Multifetal pregnancy
- Not Indicated for IUPC
- Gestation age below 37 or above 41 weeks
- 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 TOCO Detection of Contraction Events, as Compared to the IUPC, as Identified by Readers
Time frame: 9 - 42 Minutes
The presence of contractions measured by the SureCALL®, the presence of contractions measured by the TOCO, and the presence of contractions measured by the IUPC were determined by independent Readers. The Odds Ratio of SureCALL® contractions to IUPC contractions was calculated, and the Odd Ratio of TOCO contractions to IUPC contractions was calculated. Reader Correspondence was determined by a General Linear Mixed Model.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Timothy B Waterhouse, MD principal investigator
Reproductive Research Technologies, LP
3 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 - Labor Monitoring, run by Reproductive Research Technologies, LP at 3 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 4 inclusion and 4 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 15 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 15 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 TOCO Detection of Contraction Events, as Compared to the IUPC, as Identified by Readers (time frame: 9 - 42 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 15 Mar 2011.