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Discerning Pathological and Braxton Hicks Contractions in Mid-Trimester Gestation

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41HD072684-01
Agency Tracking Number: R41HD072684
Amount: $99,718.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NICHD
Solicitation Number: PA11-097
Solicitation Year: 2012
Award Year: 2012
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
United States
DUNS: 844673413
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 (410) 955-8496
Business Contact
Phone: (443) 451-7181
Research Institution
Office of Research Administration Miller Research Building 733 N. Broadway Suite 117
United States

 () -
 Nonprofit College or University

DESCRIPTION (provided by applicant): This STTR Phase I Project will determine if uterine activity measured from the utero-cervico- vaginal wall can be a predictor for discerning Braxton Hicks (false) contractions and pathological (true) labor contractionsin mid-gestation pregnancies. We will use a previously developed prototype to measure uterine activity from the utero-cervico-vaginal interface that has shown comparable results to abdominal electrohysterography (EHG). Published to have a high specificity,EHG's largest hurdle to commercialization is its low sensitivity for predicting preterm labor. Therefore, by bypassing the abdominal surface, we will increase the sensitivity of the technology and its likelihood for commercialization success. The device will be compared to an intrauterine pressure catheter (IUPC) and the tocodynamometer (TOCO) in fifteen mid-gestation ewes to validate the presence of uterine activity. We will deliver oxytocin intravenously to initiate contractions in th sheep until distinct contractions are detected, then the device, IUPC and TOCO will record all uterine activity simultaneously for two hours. When comparing the devices, the IUPC will be considered the control for contraction measurements. With the data acquired from these experiments, we will implement a novel methodology and investigate various frequency bands of the uterine activity signal to create an output that will aid physicians in determining if a presenting patient has Braxton Hicks contractions or pathological labor contractions. In analyzing the data, the frequency bands will be isolated with a band pass filter. And finally, obstetricians and nurses will be surveyed to confirm whether our presentation of the data is easy to understand. Upon successful completion ofthis STTR Phase I project, the technology will have the potential to reduce overtreatment and misdiagnosis rates of preterm labor and cervical incompetence, as well as to improve neonatal outcomes. PUBLIC HEALTH RELEVANCE: This project will advance uterine contraction monitoring in pregnant women to increase the effectiveness of antenatal surveillance. Compared to the current standard of care, we will detect even the faintest contractions by measuring electrical signals directly from the cervix and tell apart true contractions that lead to birth and false ones that do not. In the end, we will optimize a device and create a method that will potentially allow for timely interventions and a reduction in overtreatment.

* Information listed above is at the time of submission. *

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