S. Weymouth, Massachusetts 02190


Purpose:

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.


Study summary:

Specific Aim 1: To develop a technique for the quantitative analysis of fetal heart-rate (FHR) data recorded during labor using advanced mathematical techniques, including pattern-recognition analysis. - Specific Aim 2: To develop the capacity to measure fetal cardiac data using EKG sensors applied to the maternal abdomen during labor. - Specific Aim 3: To validate prenatal non-invasive measurement of the fetal QTc interval. - Specific Aim 4: To develop and validate the capacity to measure uterine contractions using the uterine EMG signal recorded from maternal skin-surface electrodes. - Specific Aim 5: Collect clinical data related to medication usage and hypoxia.


Criteria:

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 (pushing, in severe pain, etc.)


NCT ID:

NCT02320279


Primary Contact:

Principal Investigator
Adam Wolfberg, MD
South Shore Hospital

Adam Wolfberg, MD
Phone: 781-624-8000
Email: adam@mindchild.com


Backup Contact:

N/A


Location Contact:

S. Weymouth, Massachusetts 02190
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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