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

NCT01165879 | Unknown

• 1 other identifier: HTA5347
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

Pregnancy; Term; Preterm; Uterine Contractions

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  two years

• To evaluate patient safety

  Measurements of device related adverse events throughout the study.

  one year

Secondary Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pergnant women which are admitted to Meir Medical Center with complaints of uterine contractions starting.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OB-Tools Ltd.: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, 44281, Israel

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Tal Shental Biron, MD

  Meir Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tal Shental Biron, MD

CONTACT

972-577482716; Tal.Biron-Shental@clalit.org.il

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 18, 2010
• First Posted: July 20, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2012
• Last Updated: June 10, 2011

Record last verified: 2010-07

Locations

IL (1)