NCT02546011

Brief Summary

The goal of this study is to compare the amount of time that the fetal heart tones are traced in babies just at or beyond viability using a traditional device compared to the Monica device.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

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

January 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 5, 2016

Status Verified

August 1, 2016

Enrollment Period

2.5 years

First QC Date

September 8, 2015

Last Update Submit

August 4, 2016

Conditions

Fetal Heart Tracing

Outcome Measures

Primary Outcomes (1)

  • To compare the amount of time that the fetal heart tones are traced in babies just at or beyond viability using a traditional device compared to the Monica device

    This study is to compare the amount of time that the fetal heart tones are traced in babies just at or beyond viability using a traditional device compared to the Monica device.

    How long can hetal heart tracings be capture continuously

Interventions

Fetal Heart Rate MonitorOTHER

Standard of care, not part of research

Eligibility Criteria

Age13 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The potential participants will be on the antepartum service so we will be providing them with antepartum and obstetrical care clinically.

You may qualify if:

  • Pregnant patients between 24 and 28 weeks admitted to the antepartum service

You may not qualify if:

  • Patients with a non viable pregnancy
  • Patients with multiple gestation
  • Clinically Unstable patients
  • Non English speaking patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Mary's Health Center

St Louis, Missouri, 63117, United States

Location

Study Officials

  • Gary Fruhman, MD

    St. Louis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

September 8, 2015

First Posted

September 10, 2015

Study Start

January 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 5, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)