Labor Clinical Trial
Official title:
The Fetal EKG Study
The objective is to contribute data to ongoing research activities focused on identification of EKG waveform changes in the context of clinical conditions and maternal medication use. Additionally, to develop the capacity to measure contractions more accurately and more reliably using skin-surface electrodes.
Status | Recruiting |
Enrollment | 900 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Women who are pregnant or in labor who are having their fetus' heart rate monitored continuously and able to consent - 18 years old or older. - Gestational age of 24-42 weeks. - Any method of fetal heart rate monitoring. - Pregnant women in labor as well as women who are not in labor. - Pregnant women who are admitted to labor and delivery for scheduled c-sections. Exclusion Criteria: - Women unable to consent - Women under sedation or systemic anesthesia, and women who have diminished cognitive capacity - Women in extremis (in severe pain, etc.) - Women who are using the Mindchild device for clinical monitoring. |
Country | Name | City | State |
---|---|---|---|
United States | South Shore Hospital | South Weymouth | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Mindchild Medical Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quantitative FHR | Quantitative analysis of fetal heart-rate data recorded during labor using advanced mathetmatical techniques, including pattern-recognition analysis using EKG electrodes applied to the maternal abdomen. | During Labor | |
Secondary | Uterine contractions | Uterine contractions will be identified by analyzing data from surface electrodes to identify patterns consistent with uterine muscle coordinated shortening. These data will be compared to data from either the external tocometer or the internal IUPC. Cross correlation analysis will be used to compare the two signals and validate the analysis of uterine EMG signal. | During labor |
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