NCT01400880

Brief Summary

The specific goal of the proposed research is to develop a reliable, non-invasive fetal and maternal heart rate and contraction monitor that is unaffected by obesity and requires less nursing intervention than the tocodynamometer and Doppler ultrasound.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

July 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
11 months until next milestone

Results Posted

Study results publicly available

February 12, 2015

Completed
Last Updated

February 12, 2015

Status Verified

February 1, 2015

Enrollment Period

2.8 years

First QC Date

July 21, 2011

Results QC Date

September 9, 2014

Last Update Submit

February 10, 2015

Conditions

Pregnancy

Keywords

Maternal Fetal Monitoring

Outcome Measures

Primary Outcomes (1)

  • Comparison of Electrode Sensor and TOCO Detection of Contraction Events, as Compared to IUPC

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

    Stage I and II Labor

Study Arms (1)

Pregnant

In Labor

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Laboring women in Labor and Delivery ward

You may qualify if:

  • Women between the ages of 18 and 50 years old
  • \>/= 34 weeks gestation
  • Single viable fetus in cephalic presentation

You may not qualify if:

  • Bleeding or uterine scarring

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida College of Medicine

Gainesville, Florida, 32611, United States

Location

Results Point of Contact

Title
Dr. Tony Gregg
Organization
University of Florida
greggar@ufl.edu
352-265-0111

Study Officials

  • Anthony Gregg, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

July 21, 2011

First Posted

July 22, 2011

Study Start

July 1, 2011

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

February 12, 2015

Results First Posted

February 12, 2015

Record last verified: 2015-02

Locations

US(1)