Trial Outcomes & Findings for Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring Patients by Practicing Clinicians (NCT NCT01282723)

Results Overview

The presence of contractions measured by the SureCALL®, the presence of contractions measured by the TOCO, and the presence of contractions measured by the IUPC were determined by independent Readers. The Odds Ratio of SureCALL® contractions to IUPC contractions was calculated, and the Odd Ratio of TOCO contractions to IUPC contractions was calculated. Reader Correspondence was determined by a General Linear Mixed Model.

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

Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring Patients by Practicing Clinicians

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

The presence of contractions measured by the SureCALL®, the presence of contractions measured by the TOCO, and the presence of contractions measured by the IUPC were determined by independent Readers. The Odds Ratio of SureCALL® contractions to IUPC contractions was calculated, and the Odd Ratio of TOCO contractions to IUPC contractions was calculated. Reader Correspondence was determined by a General Linear Mixed Model.

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, as Identified by Readers True Positive Fraction	1.47 Odds Ratio Interval 1.1 to 1.95
Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC, as Identified by Readers False Positive Fraction	0.85 Odds Ratio Interval 0.61 to 1.17

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