Trial Outcomes & Findings for Comparison of SureCALL® EMG Labor Monitor® and Tocodynamometer to Intrauterine Pressure Catheter Measurement (IUPC) Measurement in Pregnant Women (NCT NCT01282710)

Results Overview

Contraction timing as measured by the SureCALL® and contraction timing as measured by the TOCO, both compared to the contraction timing as measured by the IUPC gold standard. The contraction timing values of SureCALL® and TOCO were then compared.

Recruitment status

COMPLETED

Target enrollment

20 participants

Primary outcome timeframe

9 - 42 Minutes

Results posted on

2011-03-15

Participant Flow

Participant milestones

Participant milestones
Measure	Pregnant, In Labor Monitored simultaneously by SureCALL®, TOCO, and IUPC
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of SureCALL® EMG Labor Monitor® and Tocodynamometer to Intrauterine Pressure Catheter Measurement (IUPC) Measurement in Pregnant Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pregnant, In Labor n=20 Participants Monitored simultaneously by SureCALL®, TOCO, and IUPC
Age, Categorical <=18 years	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	24.85 years STANDARD_DEVIATION 4.38 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 9 - 42 Minutes

Contraction timing as measured by the SureCALL® and contraction timing as measured by the TOCO, both compared to the contraction timing as measured by the IUPC gold standard. The contraction timing values of SureCALL® and TOCO were then compared.

Outcome measures

Outcome measures
Measure	Pregnant, In Labor n=20 Participants Monitored simultaneously by SureCALL®, TOCO, and IUPC
Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC SureCALL® and IUPC Peak Time Difference	-0.73 Seconds Standard Deviation 9.22
Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC TOCO and IUPC Peak Time Difference	-1.74 Seconds Standard Deviation 8.25

Adverse Events

Pregnant, In Labor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jack McCrary

Reproductive Research Technologies, LP

Phone: 7136800200

Email: [email protected]

Results disclosure agreements

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