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Completed

NCT Number: NCT01881685

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

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About this study

The purpose of the study is to:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Uterine contraction measurement

    Time frame: During Labor

    Uterine contraction monitoring using skin surface electrodes

Sponsors and collaborators

Lead sponsor

Mindchild Medical Inc.

Industry

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 20, 2013
Registry last updated
Sep 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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