Pregnancy; Habitual AborterNCT01280357

Accuracy and Reliability of Fetal Heart Rate and Uterine Contraction Monitoring Method

A study testing Monica AN24 (K101081) and Philips 50XM in people with Pregnancy; Habitual Aborter and Weeks of Gestation 37 or More, run by Monica Healthcare Ltd at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Clinical Investigation Protocol for a study designed to determine the equivalence of the Monica AN24 monitor to Philips 50XM for fetal heart rate (FHR) and uterine contraction (UC) monitoring during labor. The study will be carried out on subjects in the first and second stages of labor. Read more about this study

Who is it for?: Ages 15 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for: Pregnancy; Habitual Aborter, Weeks of Gestation 37 or More
What is being tested?: Monica AN24 (K101081) and Philips 50XM
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 2 sitesUnited States
Study dates: Feb 2010to Sep 2010
Phase: Interventional
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
Healthy volunteers accepted
Child, Adult

Who may be able to join

Pregnant, age 15-40
Term gestation (>36 completed weeks)
Singleton fetus
Active labor
Vertex presentation
Requiring internal monitoring

Who cannot join

Clinical contraindication for Intra Uterine Pressure Catheter
Major fetal malformation

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Queens Hospital Center
New York, New York, 11432
Temple University
Philadelphia, Pennsylvania, 19140

Other trials in United States

About this study

Official title: Study to Determine Substantial Equivalence of Electrohysterography (EHG) Monitoring to Tocodynanometer Monitoring

Read the detailed description

The study is a prospective, randomized, single-center observational study designed to compare the Fetal Heart Rate (FHR) and Uterine Activity (UA) output data obtained by the Monica AN24 monitor during the first and second stages of labor to those generated by existing FDA-approved devices.Patients were enrolled at the facility but the patient details were removed from the results in order that the data could be randomized for the statistical analysis.

Conditions: Pregnancy; Habitual Aborter, Weeks of Gestation 37 or More
Being tested: Monica AN24 (K101081), Philips 50XM
Keywords: Fetal Heart Rate (FHR), Uterine Activity (UA), Labor & Delivery
Medical subject headings: Abortion, Habitual

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Monica AN24 (K101081)Device
Also called Philips Series 50XM (K954351)
If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM
Philips 50XMDevice
If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM

Study groups in NCT01280357
Study group	Role	What they receive
Monitor Philips 50XM (K954351)	Active comparator	CTG Fetal Monitor If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM Receives: Device: Philips 50XM
Monica AN24 (K101801)	Experimental	EHG Fetal Monitor Receives: Device: Monica AN24 (K101081)

What is being measured

The primary outcome is the main question the study is designed to answer.

The Mean Positive Percentage Agreement (PPA) for Fetal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM
During Labor \& delivery, fetal heart rate was measured between the Monica AN24 \& the Philips 50XM and the waveforms of the 2 devices were measured to see the percentage of time they were in agreement.
Measured: during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour
The Mean Positive Percentage Agreement (PPA) for Maternal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM
During Labor \& delivery, maternal heart rate was measured between the Monica AN24 \& the Philips 50XM and the waveforms of the 2 devices were measured to see the percentage of time they were in agreement.
Measured: during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour

Secondary outcomes (1)

The Mean Positive Percentage Agreement for Uterine Contractions Between the Monica AN24 & The Philips 50XM
During labor and delivery uterine contractions were measured between the Monica AN24 \& the philips 50XM, the waveforms of the two devices were measured to see the percentage of time they were in agreement
Measured: between 35 mins & 15hrs during first & second stage labor

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2010Sep 2010

First posted20 Jan 2011 (estimated)
Study startFeb 2010
Primary completionJun 2010
Study completionSep 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; Habitual AborterStudies 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: Diagnosis
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01280357
Sponsor's protocol ID: MHL101801
Status last verified: Mar 2013
First submitted: 19 Jan 2011
Last updated: 21 Mar 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pregnancy; Habitual Aborter trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study to Determine Substantial Equivalence of Electrohysterography (EHG) Monitoring to Tocodynanometer Monitoring
ClinicalTrials.gov ID: NCT01280357
Acronym / sponsor ID: MHL101801
Conditions: Pregnancy; Habitual Aborter, Weeks of Gestation 37 or More
Keywords: Fetal Heart Rate (FHR), Uterine Activity (UA), Labor & Delivery
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Monica Healthcare LtdIndustry (pharma, biotech, devices)
Study start: Feb 2010
Primary completion: Jun 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 20 Jan 2011 (estimated)
Results: Posted 21 Mar 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Monitor Philips 50XM (K954351)	Active comparator	Device: Philips 50XMCTG Fetal Monitor If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM
Monica AN24 (K101801)	Experimental	Device: Monica AN24 (K101081)EHG Fetal Monitor

Who may qualify

Ages: 15 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

Pregnant, age 15-40
Term gestation (>36 completed weeks)
Singleton fetus
Active labor
Vertex presentation

Key exclusion criteria (2 listed)

Clinical contraindication for Intra Uterine Pressure Catheter
Major fetal malformation

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
Monica AN24 (K101081)Also: Philips Series 50XM (K954351)If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM	Device	Monica AN24 (K101801)
Philips 50XMIf not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM	Device	Monitor Philips 50XM (K954351)

Primary outcome

The Mean Positive Percentage Agreement (PPA) for Fetal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM
Time frame: during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour
During Labor \& delivery, fetal heart rate was measured between the Monica AN24 \& the Philips 50XM and the waveforms of the 2 devices were measured to see the percentage of time they were in agreement.
The Mean Positive Percentage Agreement (PPA) for Maternal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM
Time frame: during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour
During Labor \& delivery, maternal heart rate was measured between the Monica AN24 \& the Philips 50XM and the waveforms of the 2 devices were measured to see the percentage of time they were in agreement.

1 secondary outcome

The Mean Positive Percentage Agreement for Uterine Contractions Between the Monica AN24 & The Philips 50XM
Time frame: between 35 mins & 15hrs during first & second stage labor

Results and safety

Results posted to the registry on 21 Mar 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	60	34

Primary outcome: The Mean Positive Percentage Agreement (PPA) for Fetal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM

Time frame: during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour. Mean (95% Confidence Interval). Unit: Positive percantage agreement (PPA)

Measure	All Participants n = 33
Value	84.85 (73.84 to 88.89)

Population analysed: Of the remaining 34 participants in the clinical trials.The data was collected in the following manner. 31 participants were used in a FDA 6 way trial for Fetal Heart Rate (FHR)and Uterine Activity (UA) 2 participants were uesd in a 3 way trial for FHR 1 participant was used in a 3 way trial for UA Equates to 33 files for FHR \& 32 files for UA

Primary outcome: The Mean Positive Percentage Agreement (PPA) for Maternal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM

Measure	All Participants n = 33
Value	99.3 (91.3 to 100)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was monitored for the full length of the clinical trial, 6 months in total. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Philips 50XM,	0 of 60 (0%)	0 of 60 (0%)	Not reported
Monica AN24	0 of 60 (0%)	0 of 60 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pregnancy; Habitual Aborter

Not yet recruitingObservational study
Cervical Length Reference Range at 28-34 Weeks in Singleton Pregnancies
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Not yet recruitingPhase 3
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Not yet recruitingPhase 4
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Not yet recruiting
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Not yet recruitingObservational study
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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.

Wayne Cohen, MD study director

Queens Hospital Centre

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Monica AN24 (K101081) and Philips 50XM in people with Pregnancy; Habitual Aborter and Weeks of Gestation 37 or More, run by Monica Healthcare Ltd at 2 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 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 21 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 21 Mar 2013). 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?

The Mean Positive Percentage Agreement (PPA) for Fetal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM (time frame: during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour). 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?

On the ClinicalTrials.gov record for NCT01280357.

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 21 Mar 2013.