NCT01730963

Brief Summary

This multi-reader multi-case study was designed to evaluate the performance of SureCALL® Labor Monitor® (SureCALL®) directly to the standard Tocodynamometer device (TOCO).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2012

Completed
Last Updated

November 22, 2012

Status Verified

November 1, 2012

Enrollment Period

4.9 years

First QC Date

November 15, 2012

Last Update Submit

November 20, 2012

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Comparison of SureCALL® and Tocodynamometer Detection of Contraction Events, as Identified by Readers

    Agreement will be assessed by coefficient of individual agreement (CIA) derived from a dataset of all Reader-marked contractions. In addition, sensitivity and false positive rate per hours will be estimated for each patient by each reader. If CIA ≥ 0.445 (Barnhart, 2007, section 3) or CIA\>0.8, Pan 2010), the SureCALL® is not significantly different than the TOCO.

    9 - 41 Minutes

Study Arms (3)

Pregnant, Preterm, In Labor

Gestation Age at or less than 36 weeks, clinically determined to be in labor

Pregnant, Preterm, Nonlaboring

Gestation Age at or less than 36 weeks, clinically determined to not be in labor

Pregnant, Term, Nonlaboring

Gestation Age more than 36 weeks, clinically determined to not be in labor

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women with uncomplicated singleton pregnancies

You may qualify if:

  • Singleton Pregnancy
  • Informed Consent Required

You may not qualify if:

  • Multifetal Pregnancy
  • Informed Consent Not Given

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

Drexel University College of Medicine

Philadelphia, Pennsylvania, 19101, United States

Location

Southeast Texas OB/GYN Associates

Beaumont, Texas, 77702, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Woman's Hospital of Texas

Houston, Texas, 77054, United States

Location

Study Officials

  • Timothy B Waterhouse, MD

    Reproductive Research Technologies, LP

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2012

First Posted

November 21, 2012

Study Start

January 1, 2007

Primary Completion

December 1, 2011

Study Completion

September 1, 2012

Last Updated

November 22, 2012

Record last verified: 2012-11

Locations

US(5)