Measuring Uterine Electrical Activity Throughout Pregnancy and Labor Measuring Uterine Electrical Activity Throughout Pregnancy and Labor
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pregnancy
- Sponsor
- OB-Tools Ltd.
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- The study primary outcome is to demonstrate that the EUM100pro uterine contractions measurements is as good as the current methods for monitoring pregnancy in labor (tocodynamometer, IUPC).
- Last Updated
- 14 years ago
Overview
Brief Summary
The EUM100pro (Electrical Uterine Monitor)is a uterine contraction monitor which measures uterine contractions based on the electrical activity of the uterine muscle.The study will compare the EUM100pro measurements to the already existing uterine contractions monitors (tocodynamometer and Intra Uterine Pressure Catheter) in pregnant women with complaints of uterine contractions.
Detailed Description
The main objective of the study is to demonstrate that the EUM100pro is as good as the current methods for monitoring pregnancy in labor (tocodynamometer, IUPC) in measuring uterine contractions. This will be performed by measuring the expectancy of time differences between the tocodynamometer/IUPC and the EUM in the beginning, end, peak and duration of each contraction. A good correlation will be 0.9 and significance of 95%. 100 women will be recruited to the study. The measurement with the EUM100pro will not interfere with the usual clinical care, meaning- the EUM100pro will be used in addition to the standard care and monitoring.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women at term with complaint of uterine contractions at Meir Medical Center
- •Women at preterm with complaint of uterine contractions at Meir Medical Center.
- •Women at gestational age \>24 weeks
- •Subjects who understood, agreed and signed the informed consent form
Exclusion Criteria
- •Subjects who refused to sign the informed consent form
- •Abnormal fetal heart rate recording at admittance
- •Subjects with indications for immediate delivery
- •Subjects younger than 18 years of age
- •Subjects at gestational age \<24 weeks
Outcomes
Primary Outcomes
The study primary outcome is to demonstrate that the EUM100pro uterine contractions measurements is as good as the current methods for monitoring pregnancy in labor (tocodynamometer, IUPC).
Time Frame: two years
The primary outcome will be measured by correlation of timing of :peak display in beginning, during and end of peak in the EUM100pro versus the timing of the peak display in beginning, during and the end tocodynamometer and or IUPC peak.
To evaluate patient safety
Time Frame: one year
Measurements of device related adverse events throughout the study.
Secondary Outcomes
- Correlation of uterine contractions intensity between EUM100pro and Intra Uterine Pressure Catheter measurements.(one year)
- To evaluate usability of the EUM100pro(one year)
- to evaluate whether a fetal ECG can be exctraced from the electrical signal of the uterus.(one year)