Fetal Heart Rate (FHR)
Primary
· Up to 120 minutes
FHR as measured by the M•care System versus standard of care CTG device
| Group | Value | 95% CI |
|---|---|---|
| M•Care™ System | 140.1 | ± 11.4 |
| Cardiotocography (CTG) | 140.0 | ± 10.7 |
Last reviewed · How we verify
NCT05294211: M•CARE SE
Safety and Performance of a Fetal Monitoring System
Completed
Results posted
Last updated 23 May 2024
What this trial tests
trial testing M•care™ System in Pregnancy in 120 participants. Completed in 24 January 2023.
Timeline
31 August 2022
Primary endpoint
24 January 2023
24 January 2023
24 January 2023
Quick facts
| Lead sponsor | Marani Health |
|---|---|
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 120 |
| Start date | 31 August 2022 |
| Primary completion | 24 January 2023 |
| Estimated completion | 24 January 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- M•care™ System
- Cardiotocography (CTG)
Conditions studied
- Pregnancy — all drugs for Pregnancy →
Sponsor
Marani Health
Who can join
18 and older, female only, with Pregnancy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Maternal Heart Rate (MHR)
Primary
· Up to 120 minutes
MHR as measured by the M•care System versus standard of care CTG device
| Group | Value | 95% CI |
|---|---|---|
| M•Care™ System | 83.4 | ± 12.0 |
| Cardiotocography (CTG) | 83.1 | ± 12.1 |
Uterine Contractions (UC)
Secondary
· Up to 120 minutes
UC sensitivity as measured by the M•care System versus standard of care CTG device, where sensitivity is defined as the proportion of UC events identified by standard of care that are simultaneously identified by the M•care System (positive agreement).
| Group | Value | 95% CI |
|---|---|---|
| M•Care™ System + CTG | 0.57 | 0.50 – 0.63 |
Adverse events — posted to ClinicalTrials.gov
Time frame: 3 hours. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
M•Care™ System + CTG
Serious: 0/120 (0%)
Deaths: 0/120
Other adverse events (1 terms — click to expand)
| Reaction | System | M•Care™ System + CTG |
|---|---|---|
| erythema | Skin and subcutaneous tissue disorders | — |
Data from ClinicalTrials.gov NCT05294211 adverse events section.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05294211
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Pregnancy
Currently open trials in the same condition.
- NCT07405723 — Arm Position and Blood Pressure Measurement Accuracy During Pregnancy · NA · recruiting
- NCT07420621 — Preliminary Effectiveness of Enhanced Text Message + Incentives · NA · recruiting
- NCT07385807 — Exploring Fecal Calprotectin Levels, Maternal and Infant Microbiota, Infant Health, Nutrition, and Adverse Pregnancy Out · recruiting
- NCT07226492 — Cash Transfers to Pregnant Women With HIV · NA · recruiting
- NCT07435766 — Iron Absorption From IFA and MMS Supplements in Kenyan Women During the Second Trimester of Pregnancy · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT05294211 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Marani Health
- Last refreshed: 23 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05294211.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing