Measuring Uterine Electrical Activity Throughout Pregnancy and Labor Measuring Uterine Electrical Activity Throughout Pregnancy and Labor

OB-Tools

Status: Unknown

Conditions: Pregnancy

Study type: Observational

Funder types: Industry

Identifiers

NCT01165879

HTA5347

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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