NCT02024165

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
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2013

Shorter than P25 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

November 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 2, 2013

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 31, 2013

Completed
3 months 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
1.1 years until next milestone

Results Posted

Study results publicly available

May 12, 2015

Completed
Last Updated

May 12, 2015

Status Verified

April 1, 2015

Enrollment Period

5 months

First QC Date

December 2, 2013

Results QC Date

April 1, 2015

Last Update Submit

April 22, 2015

Conditions

Laboring Women With Ultrasound and FSE Monitoring

Keywords

UltrasoundFSEIUPC

Outcome Measures

Primary Outcomes (1)

  • Fetal Heart Rate Interpretability

    The Fetal Heart Rate (or FHR) of the electrode sensor will be compared to the FHR of the ultrasound when both are compared to the FSE. Percentage of time that signals are interpretable will be compared between devices

    2 hours

Study Arms (2)

Electrode Sensor, FSE

Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor, and/or FSE

Electrode Sensor, Ultrasound

Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor, and/or Ultrasound

Eligibility Criteria

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

Laboring women in Labor and Delivery Ward

You may qualify if:

  • Parturients presenting to Labor \& Delivery for labor at term (\>36 weeks completed gestation)
  • Single viable fetus in cephalic presentation
  • With FSE or IUPC for obstetric indications

You may not qualify if:

  • Multi fetal gestation
  • Contraindication to FSE or IUPC placement
  • Insufficient abdominal space for all required sensors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Winnie Palmer Hospital for Women and Babies

Orlando, Florida, 32806, United States

Location

Results Point of Contact

Title
John Busowski, MD
Organization
Winnie Palmer Hospital for Women and Babies
john.busowski@orlandohealth.com
407-435-1485

Study Officials

  • John Busowski, MD

    Winnie Palmer Hospital for Women and Babies

    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
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2013

First Posted

December 31, 2013

Study Start

November 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

May 12, 2015

Results First Posted

May 12, 2015

Record last verified: 2015-04

Locations

US(1)