Fetal Intrapartum Heart Rate FHR/ECG Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Mindchild Medical Inc.
Sponsor:
Information provided by (Responsible Party):
Mindchild Medical Inc.
ClinicalTrials.gov Identifier:
NCT01881685
First received: June 11, 2013
Last updated: September 16, 2014
Last verified: September 2014
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mindchild Medical Inc.
ClinicalTrials.gov Identifier: NCT01881685     History of Changes
Other Study ID Numbers: RP#12018
Study First Received: June 11, 2013
Last Updated: September 16, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 29, 2014