Comparative Performance of INVU™ Versus Intrauterine Pressure Catheter (IUPC) in Uterine Contractions Monitoring of Pregnant Women.
Completed · Not applicable
Conditions studied: Healthy, Pregnant Women
In brief
The primary objective of this research is to assess the agreement between INVU™ and IUPC (the gold standard) during prenatal monitoring of uterine contractions and to assess the safety of INVU™. Additional information comparing INVU™ to TOCO (the standard of care) was also collected.
Key facts
- Study ID
- NCT03889405
- Run by
- Nuvo-Group, Ltd.
- People needed
- 80
- Starts
- 2019-04-09
- Expected to finish
- 2020-01-31
- Last updated by the study team
- 2021-02-08
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Female age between 18-50
- Gestational age ≥32 + 0 weeks
- Singleton gestation
- Ability to understand and sign informed consent
- The subject is within the first stage labor, including early, active and transition phases (cervix is dilated up to 10 cm)
- The subject has an IUPC in place for clinical contraction monitoring
- Exclusion Criteria:
- BMI ≥50 and 15≤ prior pregnancy (Body Mass Index)
- Multiple gestation
- Uncontrolled Hypertension
- Known fetal Anomaly (i.e. major structural)
- 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 judgment of the investigator, are likely to be non-compliant or uncooperative during the study
- Subject who is within the second stage labor (cervix is fully dilated to 10 cm or going into the second stage of labor or more)
Where it is running
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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