Clinical trial NCT01165879: Measuring Uterine Electrical Activity Throughout Pregnancy and Labor Measuring Uterine Electrical Activity Throughout Pregnancy and Labor
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Keywords: Pregnancy
Term
Preterm
Uterine Contractions
Lead sponsor: OB-Tools Ltd.
Sponsor class: INDUSTRY
First posted: 2010-07-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pergnant women which are admitted to Meir Medical Center with complaints of uterine contractions starting.

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.

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

Primary outcomes:
measure: 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).
timeFrame: two years
measure: To evaluate patient safety
timeFrame: one year
Secondary outcomes:
measure: Correlation of uterine contractions intensity between EUM100pro and Intra Uterine Pressure Catheter measurements.
timeFrame: one year
measure: To evaluate usability of the EUM100pro
timeFrame: one year
measure: to evaluate whether a fetal ECG can be exctraced from the electrical signal of the uterus.
timeFrame: one year
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Hospital
name: Tal Shental Biron, MD
role: PRINCIPAL_INVESTIGATOR
References: