Fetal Intrapartum Heart Rate FHR/ECG Study

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. Identifier: NCT01881685
Recruitment Status : Unknown
Verified September 2014 by Mindchild Medical Inc..
Recruitment status was:  Recruiting
First Posted : June 20, 2013
Last Update Posted : September 17, 2014
Information provided by (Responsible Party):
Mindchild Medical Inc.

June 11, 2013
June 20, 2013
September 17, 2014
March 2013
December 2015   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01881685 on Archive Site
Uterine contraction measurement [ Time Frame: During Labor ]
Uterine contraction monitoring using skin surface electrodes
Same as current
Not Provided
Not Provided
Fetal Intrapartum Heart Rate FHR/ECG Study
Fetal Intrapartum Heart Rate FHR/ECG 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.

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.

Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
1 Day
Retention:   Samples Without DNA
1) umbilical cord arterial and venous blood; 2)placenta for pathological evaluation.
Non-Probability Sample
Women in labor who are having their fetus' heart rate monitored continuously
Abnormality in Fetal Heart Rate or Rhythm
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
December 2015
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Mindchild Medical Inc.
Mindchild Medical Inc.
Not Provided
Principal Investigator: Timothy Drake, MD Summa Center for Women's Health Research
Mindchild Medical Inc.
September 2014