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Fetal Intrapartum Heart Rate FHR/ECG Study

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ClinicalTrials.gov Identifier: NCT01881685
Recruitment Status : Completed
First Posted : June 20, 2013
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Mindchild Medical Inc.

Brief 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.

Condition or disease
Abnormality in Fetal Heart Rate or Rhythm

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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Fetal Intrapartum Heart Rate FHR/ECG Study
Study Start Date : March 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015



Primary Outcome Measures :
  1. 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 :
  1. 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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Ohio
Summa Center for Women's Health Research
Akron, Ohio, United States, 44304
Sponsors and Collaborators
Mindchild Medical Inc.
Investigators
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Principal Investigator: Timothy Drake, MD Summa Center for Women's Health Research

Additional Information:

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Responsible Party: Mindchild Medical Inc.
ClinicalTrials.gov Identifier: NCT01881685     History of Changes
Other Study ID Numbers: RP#12018
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2014
Additional relevant MeSH terms:
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Congenital Abnormalities