A Study Aimed at Comparing Two Methods of Contractions Monitoring (Electrical Uterine Monitor - EUM vs. Tocodynamometer) for Clinical Decision Making Regarding Treatment Among Pregnant Women With Preterm Contractions.
Sponsor study identifier
interventional
1,500
0 countries
N/A
Study Start
September 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Background: Identification and measurement of uterine contractions throughout pregnancy and labor is crucial to the well being of both mother and fetus. Prematurity is one of the major causes for adverse pregnancy outcomes, and clinical decision-making often relies on uterine frequency as recorded by a tocodynamometer, as well as on other methods including sonographic cervical length, pelvic examination. Objective: To show that the use of the EUM in preterm labor is effective in establishing true preterm labor.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 18, 2016
Actual (reported)August 23, 2016
Actual (reported)September 2016
Date type not reportedThis date has not been verified as actual or estimated.
September 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Rate of preterm deliveries
Week of gestation will be documented.
4 month
Pregnant women with gestational age 24+0/7 to 33+6/7 weeks of gestation and contractions, cramping, pelvic pressure or backache.
STUDY DESIGN 1. Explanation regarding the study and assessing eligibility criteria. 2. Signing an informed consent. 3. Recording of uterine contractions by both EUM and tocodynamometry. A correlation between EUM and tocodynamometry will be calculated. For the purpose of this study, a positive EUM or tocodynamometry will be defined as 3 at least 3 contractions in 30 minutes.
STUDY DESIGN 1. Explanation regarding the study and assessing eligibility criteria. 2. Signing an informed consent. 3. Recording of uterine contractions by both EUM and tocodynamometry. A correlation between EUM and tocodynamometry will be calculated. For the purpose of this study, a positive EUM or tocodynamometry will be defined as 3 at least 3 contractions in 30 minutes.
yariv yogev, professor
Tel Aviv Medical Center
First Submitted
August 18, 2016
First Posted
August 23, 2016
Study Start
September 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2019
Estimated (date passed)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 23, 2016
Record last verified: 2016-08
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Source: ClinicalTrials.gov.
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