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

June 11, 2013
September 16, 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 ] [ 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.
Same as current
Complete list of historical versions of study NCT01881685 on ClinicalTrials.gov Archive Site
Uterine contraction measurement [ Time Frame: During Labor ] [ Designated as safety issue: No ]
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
Description:

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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
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
Female
18 Years and older
No
United States
 
NCT01881685
RP#12018
No
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP