Trial Outcomes & Findings for Comparison of SureCALL® Labor Monitor® and Tocodynamometer Measurement in Preterm and Term Pregnant Women (NCT NCT01399229)

Results Overview

Time Stamps of the Peaks of Corresponding Contractions

Recruitment status

COMPLETED

Target enrollment

30 participants

Primary outcome timeframe

9 - 41 Minutes

Results posted on

2013-09-12

Participant milestones
Measure	Pregnant, Preterm, In Labor Pregnant preterm women independently determined to be in labor.	Pregnant, Preterm, Non Labor Pregnant preterm women independently determined to not be in labor.	Pregnant, Term, Non Labor Pregnant term women independently determined to be in labor.
Overall Study STARTED	20	5	5
Overall Study COMPLETED	20	5	5
Overall Study NOT COMPLETED	0	0	0

Withdrawal data not reported

Comparison of SureCALL® Labor Monitor® and Tocodynamometer Measurement in Preterm and Term Pregnant Women

Baseline characteristics by cohort
Measure	Pregnant n=30 Participants The study focused on recruiting laboring preterm patients, nonlaboring preterm patients, and nonlaboring term patients.
Age, Categorical <=18 years	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	29.50 years STANDARD_DEVIATION 6.75 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

Timeframe: 9 - 41 Minutes

Time Stamps of the Peaks of Corresponding Contractions

Outcome measures
Measure	Pregnant Patents With Uterine Contractions n=30 Participants Patient contractions were monitored with both SureCALL® Labor Monitor® and Tocodynamometer. The times of peak contractions recorded by both devices were compared, and the time differences between contractions were assessed.
Comparison of SureCALL® and Tocodynamometer Detection of Contraction Event Timing	0.99 Seconds Standard Deviation 15.17

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Reproductive Research Technologies, LP

Phone: 7136800200

Principal investigator is a sponsor employee PIs may publish or present results of the study after the expiration of 12 months from completion. Publications or presentations are subject to the protection of confidential information or patentable information.
Publication restrictions are in place

Restriction type: OTHER