N/A
N=120
Safety and Performance of a Fetal Monitoring System
Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT05294211 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Fetal Heart Rate (FHR) — 140.1; 140.0 BPM
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- M•care™ System (Device); Cardiotocography (CTG) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Marani Health
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fetal Heart Rate (FHR) |
140.1; 140.0 | — |
| PRIMARY Maternal Heart Rate (MHR) |
83.4; 83.1 | — |
| SECONDARY Uterine Contractions (UC) |
0.57 | — |
Summary
The objective of this study is to demonstrate the safety and performance of the M•care™ System for use in antenatal monitoring of pregnant women ≥ 32 weeks' gestation.
Eligibility Criteria
Inclusion Criteria
- Able to provide informed consent and follow study instructions
- 18 years of age or older
- Pregnant subjects ≥ 32 weeks' gestation
- Singleton pregnancy
- BMI ≥15, pre-pregnancy
- BMI ≤45, pre-pregnancy
- Belly circumference ≥80 cm and ≤ 130 cm
Exclusion Criteria
- Known major fetal malformation or chromosome abnormality
- Abdominal medical skin conditions, including surgical incisions, open wounds with our without infections, edema, or irritation
- Participants with implanted electronic devices (pacemakers, defibrillator, etc.)
- Involvement in another clinical trial currently or previously in this pregnancy that, in the investigator's opinion, would affect the conduct of this study
- Medical or obstetric problem that in the investigator's opinion would make the participant incapable of taking part in the study
- In the investigator's opinion, the participant is not likely to be available for the minimum 60 minutes of the monitoring session
- History of skin allergies to cosmetics and lotions
- Known allergies to silver, nylon, or polyester
Data sourced from ClinicalTrials.gov (NCT05294211). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.