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Completed

NCT Number: NCT03504189

Evaluating the Safety of PregSense™ and Compare Its Performance to CTG in Prenatal Monitoring of Pregnant Subjects

This clinical study will evaluate the safety of PregSense™ and Comparative Performance of PregSense™ versus CTG in Prenatal Monitoring of Pregnant subjects.

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Key information

Conditions

Pregnancy

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Heidelberg University Womens Hospital, Heidelberg, Germany

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About this study

PregSense™ is a maternal-fetal monitor that non-invasively measures and displays fetal heart rate, maternal hear rate and uterine contractions. This study will be performed to collect and digitally record data from PregSense™ and the standard of care (CTG) in order to provide evidence of safety and agreement between PregSense™ and the gold standard NST device.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female age between 18-50
  • Gestational age > 32 + 0 weeks
  • Singleton gestation
  • Ability to understand and sign informed consent

Exclusion criteria

  • BMI (Body Mass Index) ≥ 45 and ≤15 prior pregnancy
  • Multiple gestation
  • Uncontrolled Hypertension
  • Fetal Anomaly
  • Subjects with skin problems in the abdominal area (such as flesh wounds, cuts in the skin, skin rashes, etc.)
  • Subjects with implanted electronic devices (pacemaker, defibrillator, etc.)
  • Subjects who, in the judgement of the investigator, are likely to be non-compliant or uncooperative during the study

Treatment and study plan

PregSense™

Device

PregSense™ wearable device will be applied for maternal-fetal monitoring

Cardiotocopraphy (CTG)

Device

Cardiotocopraphy (CTG) will be applied for maternal-fetal monitoring

Primary outcomes

  1. Fetal Heart Rate

    Time frame: 30 Minutes

    Provide evidence of safety and FHR agreement between PregSense™ and the standard of care devices (i.e. CTG)

  2. Maternal Heart Rate

    Time frame: 30 MInutes

    Provide evidence of safety and agreement between MHR collected via the PregSense™ and the standard of care devices (i.e. CTG)

Secondary outcomes

  1. Uterine Contractions

    Time frame: 30 Minutes

    Compare uterine contractions from Pregsense™ versus CTG.

Other outcomes

  1. Safety Measures

    Time frame: Through study completion, an average of 1 hour

    Evaluate device related adverse events

Sponsors and collaborators

Lead sponsor

Nuvo-Group, Ltd.

Industry

Registry information

Official study title

Clinical Study Evaluating the Safety of PregSense and Comparative Performance of PregSense Versus CTG in Prenatal Monitoring of Pregnant Subjects

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 20, 2018
Registry last updated
Feb 18, 2020

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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