Abnormality in Fetal Heart Rate or RhythmNCT01881685
Fetal Intrapartum Heart Rate FHR/ECG Study
An observational study of Abnormality in Fetal Heart Rate or Rhythm, run by Mindchild Medical Inc. at 2 sites in United States.
Trial summary
The objective of the study is to evaluate the association between certain markers in the blood of neonatal brain injury and specific Fetal Heart Rate monitoring findings using the device under study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abnormality in Fetal Heart Rate or Rhythm
- How many people
- 400 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2013to Dec 2015
- How long will I take part?
- 1 Day
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women in labor who are having their fetus' heart rate monitored continuously
Who may be able to join
- Pregnant women in their third trimester and Women in labor (the progressive effacement and dilatation of the cervix) who are having their fetus' heart rate monitored continuously will form the eligible population for recruitment into our study
- 18 years old or older
- Women with the diagnosis of fetal intrauterine growth restriction may be included.
Who cannot join
- Speakers of languages other than English
- Gestational age less than 24 weeks 0 days
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Summa Center for Women's Health Research
Akron, Ohio, 44304
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The objective of the study is to evaluate the association between certain markers in the blood of neonatal brain injury and specific Fetal Heart Rate monitoring findings using the device under study.
Read the detailed description
The purpose of the study is to:
- evaluate the association between serologic markers of neonatal brain injury and the specific FHR monitoring findings using the investigational device;
- investigate the relationship between selective serotonin reuptake inhibitor (SSRI) antidepressants and the QT interval of the fetal heart. Specifically, examine the potential association between maternal SSRI use and the fetal QT interval,and;
- develop the capacity to measure uterine contractions during labor using non-invasive electrodes that measure the electrical signal from the uterine muscle.
For this study, the investigational device will not be used to diagnose or treat as it will be used in concert with the current standard of care monitors.
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative FHR patterns predictive of adverse neonatal outcome
1)quantitative analysis of fetal heart-rate (FHR) data recorded during labor using advanced mathematical techniques, including pattern-recognition analysis using EKG stickers applied to the maternal abdomen.
Measured: During Labor
Secondary outcomes (1)
Uterine contraction measurement
Uterine contraction monitoring using skin surface electrodes
Measured: During Labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormality in Fetal Heart Rate or RhythmStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Mindchild Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Drake, MD, Principal investigator, Summa Center for Women's Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881685
- Sponsor's protocol ID
- RP#12018
- Status last verified
- Sep 2014
- First submitted
- 11 Jun 2013
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Intrapartum Heart Rate FHR/ECG Study
- ClinicalTrials.gov ID
- NCT01881685
- Acronym / sponsor ID
- RP#12018
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Mindchild Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Jun 2013 (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.
The objective of the study is to evaluate the association between certain markers in the blood of neonatal brain injury and specific Fetal Heart Rate monitoring findings using the device under study.
Detailed description
The purpose of the study is to:
- evaluate the association between serologic markers of neonatal brain injury and the specific FHR monitoring findings using the investigational device;
- investigate the relationship between selective serotonin reuptake inhibitor (SSRI) antidepressants and the QT interval of the fetal heart. Specifically, examine the potential association between maternal SSRI use and the fetal QT interval,and;
- develop the capacity to measure uterine contractions during labor using non-invasive electrodes that measure the electrical signal from the uterine muscle.
For this study, the investigational device will not be used to diagnose or treat as it will be used in concert with the current standard of care monitors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women in labor who are having their fetus' heart rate monitored continuously
Key inclusion criteria (3 listed)
- Pregnant women in their third trimester and Women in labor (the progressive effacement and dilatation of the cervix) who are having their fetus' heart rate monitored continuously will form the eligible population for recruitment into our study
- 18 years old or older
- Women with the diagnosis of fetal intrauterine growth restriction may be included.
Key exclusion criteria (2 listed)
- Speakers of languages other than English
- Gestational age less than 24 weeks 0 days
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
Quantitative FHR patterns predictive of adverse neonatal outcome
Time frame: During Labor
1)quantitative analysis of fetal heart-rate (FHR) data recorded during labor using advanced mathematical techniques, including pattern-recognition analysis using EKG stickers applied to the maternal abdomen.
1 secondary outcome
Uterine contraction measurement
Time frame: During Labor
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 18 Sep 2019.
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 Drake, MD principal investigator
Summa Center for Women's Health Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abnormality in Fetal Heart Rate or Rhythm, run by Mindchild Medical Inc. 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 3 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 18 Sep 2019. 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?
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?
Quantitative FHR patterns predictive of adverse neonatal outcome (time frame: During Labor). 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 18 Sep 2019.