Pregnancy Abnormal Clinical Trial
Official title:
Can Spontaneous Fetal EEG Be Recorded During Labor Using the Established Fetal Scalp Electrode Heart Rate Monitoring System?
NCT number | NCT03013569 |
Other study ID # | STUDY00003276 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2017 |
Est. completion date | June 2023 |
Verified date | January 2024 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 11 |
Est. completion date | June 2023 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: Women in labor, with medical complications of pregnancy, such as IUGR, hypertension, diabetes, or obesity (BMI over 30). Exclusion Criteria: 1. Maternal or fetal infection or bleeding disorder; 2. Birth through Caesarian section will only be excluded if decided a priori; 3. Non-English speaking. |
Country | Name | City | State |
---|---|---|---|
United States | University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Fetal acidemia | EEG recordings will be used to validate whether the EEG-FHR patterns are predictive of fetal acidemia intrapartum | 12 month recruitment period |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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