Trial Outcomes & Findings for Electrode-based Sensor for Non-invasive Fetal Heart Rate and EMG Monitoring With Improved Reliability (NCT NCT01400880)
NCT ID: NCT01400880
Last Updated: 2015-02-12
Results Overview
Contraction timing as measured by the electrode sensor and contraction timing as measure by the TOCO, both compared to the contraction timing as measured by the IUPC gold standard. The contraction timing values of the electrode sensor and TOCO were then compared.
COMPLETED
103 participants
Stage I and II Labor
2015-02-12
Participant Flow
Participant milestones
| Measure |
Electrode Sensor, TOCO and IUPC
Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor, TOCO and IUPC
|
|---|---|
|
Overall Study
STARTED
|
103
|
|
Overall Study
COMPLETED
|
101
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Electrode-based Sensor for Non-invasive Fetal Heart Rate and EMG Monitoring With Improved Reliability
Baseline characteristics by cohort
| Measure |
Primary
n=101 Participants
Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
101 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Pregnant Women
|
101 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Stage I and II LaborPopulation: Pregnant women between the ages of 18-50 with a single viable fetus in stages I and/or II of labor
Contraction timing as measured by the electrode sensor and contraction timing as measure by the TOCO, both compared to the contraction timing as measured by the IUPC gold standard. The contraction timing values of the electrode sensor and TOCO were then compared.
Outcome measures
| Measure |
Electrode Sensor, TOCO and IUPC
n=101 Participants
Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation studied with electrode sensor, Tocodynamometer and IUPC
|
|---|---|
|
Comparison of Electrode Sensor and TOCO Detection of Contraction Events, as Compared to IUPC
TOCO patient group
|
2.98 seconds
Standard Deviation 3.28
|
|
Comparison of Electrode Sensor and TOCO Detection of Contraction Events, as Compared to IUPC
Electrode Sensor patient group
|
3.95 seconds
Standard Deviation 2.65
|
Adverse Events
Primary
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Primary
n=103 participants at risk
Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation
|
|---|---|
|
Infections and infestations
Chorioamnionitis
|
12.6%
13/103 • Number of events 13 • Adverse events occurred throughout the study dates starting 8/1/11 and ending 4/25/13. 1 year 9 months.
All adverse events were recorded, even if the event was not directly related to the study. Some patients developed infection directly after data collection started and thus were already infected, not being caused by the study. Also, C-sections were reported as it disrupted the data collection and was not a foreseeable event.
|
|
Surgical and medical procedures
c-section
|
1.9%
2/103 • Number of events 2 • Adverse events occurred throughout the study dates starting 8/1/11 and ending 4/25/13. 1 year 9 months.
All adverse events were recorded, even if the event was not directly related to the study. Some patients developed infection directly after data collection started and thus were already infected, not being caused by the study. Also, C-sections were reported as it disrupted the data collection and was not a foreseeable event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place