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Fetal Intrapartum Heart Rate FHR/ECG Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2014 by Mindchild Medical Inc..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01881685
First Posted: June 20, 2013
Last Update Posted: September 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mindchild Medical Inc.
  Purpose
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.

Condition
Abnormality in Fetal Heart Rate or Rhythm

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Fetal Intrapartum Heart Rate FHR/ECG Study

Further study details as provided by Mindchild Medical Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Uterine contraction measurement [ Time Frame: During Labor ]
    Uterine contraction monitoring using skin surface electrodes


Biospecimen Retention:   Samples Without DNA
1) umbilical cord arterial and venous blood; 2)placenta for pathological evaluation.

Estimated Enrollment: 400
Study Start Date: March 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Detailed Description:

The purpose of the study is to:

  1. evaluate the association between serologic markers of neonatal brain injury and the specific FHR monitoring findings using the investigational device;
  2. 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;
  3. 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women in labor who are having their fetus' heart rate monitored continuously
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Speakers of languages other than English
  • Gestational age less than 24 weeks 0 days
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881685


Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: James Greenberg, MD    617-732-5500      
Principal Investigator: James Greenberg, MD         
United States, Ohio
Summa Center for Women's Health Research Recruiting
Akron, Ohio, United States, 44304
Contact: Amy Alexander, BS    330-375-6119      
Principal Investigator: Timothy Drake, MD         
Sponsors and Collaborators
Mindchild Medical Inc.
Investigators
Principal Investigator: Timothy Drake, MD Summa Center for Women's Health Research
  More Information

Responsible Party: Mindchild Medical Inc.
ClinicalTrials.gov Identifier: NCT01881685     History of Changes
Other Study ID Numbers: RP#12018
First Submitted: June 11, 2013
First Posted: June 20, 2013
Last Update Posted: September 17, 2014
Last Verified: September 2014