NCT03013569

Brief Summary

This is a pilot feasibility study for a new application of an approved fetal heart rate monitoring device system. The objective of this study is to validate the feasibility of acquiring the new modality of human fetal bioelectrical activity, EEG, derived from the routinely used scalp fetal heart rate (FHR) monitor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

5.9 years

First QC Date

January 4, 2017

Last Update Submit

January 16, 2024

Conditions

Pregnancy Abnormal

Outcome Measures

Primary Outcomes (1)

  • Recording spontaneous EEG during labor

    The investigators will record spontaneous fetal EEG activity during labor using a custom-build IRB-approved fetal EEG device. The validity of the recorded data will be analyzed based on the physiological characteristics of the data such as amplitude and frequency properties as well as the behavioral state architecture (duration of low voltage/high frequency and high voltage/low frequency states as well as of the indeterminate states). The data will be analyzed in conjunction with the accompanying fetal heart rate recordings which also show behavioral state fluctuations.

    12 month recruitment period

Secondary Outcomes (1)

  • Fetal acidemia

    12 month recruitment period

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant women of reproductive age in labor at term

You may qualify if:

  • Women in labor, with medical complications of pregnancy, such as IUGR, hypertension, diabetes, or obesity (BMI over 30).

You may not qualify if:

  • Maternal or fetal infection or bleeding disorder;
  • Birth through Caesarian section will only be excluded if decided a priori;
  • Non-English speaking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (5)

  • Wang X, Durosier LD, Ross MG, Richardson BS, Frasch MG. Online detection of fetal acidemia during labour by testing synchronization of EEG and heart rate: a prospective study in fetal sheep. PLoS One. 2014 Sep 30;9(9):e108119. doi: 10.1371/journal.pone.0108119. eCollection 2014.

    PMID: 25268842BACKGROUND

  • Frasch MG, Durosier LD, Gold N, Cao M, Matushewski B, Keenliside L, Louzoun Y, Ross MG, Richardson BS. Adaptive shut-down of EEG activity predicts critical acidemia in the near-term ovine fetus. Physiol Rep. 2015 Jul;3(7):e12435. doi: 10.14814/phy2.12435.

    PMID: 26149280BACKGROUND

  • Xu A, Durosier LD, Ross MG, Hammond R, Richardson BS, Frasch MG. Adaptive brain shut-down counteracts neuroinflammation in the near-term ovine fetus. Front Neurol. 2014 Jun 30;5:110. doi: 10.3389/fneur.2014.00110. eCollection 2014.

    PMID: 25071698BACKGROUND

  • Frasch MG, Keen AE, Gagnon R, Ross MG, Richardson BS. Monitoring fetal electrocortical activity during labour for predicting worsening acidemia: a prospective study in the ovine fetus near term. PLoS One. 2011;6(7):e22100. doi: 10.1371/journal.pone.0022100. Epub 2011 Jul 15.

    PMID: 21789218BACKGROUND

  • Castel A, Frank YS, Feltner J, Karp FB, Albright CM, Frasch MG. Monitoring Fetal Electroencephalogram Intrapartum: A Systematic Literature Review. Front Pediatr. 2020 Sep 11;8:584. doi: 10.3389/fped.2020.00584. eCollection 2020.

    PMID: 33042922RESULT

Related Links

Study Officials

  • Martin G Frasch, MD, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor, Obstetrics and Gynecology

Study Record Dates

First Submitted

January 4, 2017

First Posted

January 6, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2022

Study Completion

June 1, 2023

Last Updated

January 18, 2024

Record last verified: 2024-01

Locations

US(1)