Establish the uSI Values and End-user Training Material That Will be Used to Guide Oxytocin Dosing Actions

NCT04548453 | Unknown Early Phase 1 FDA Device

• 1 other identifier: uSI range setting study
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Patients receiving oxytocin for induction or augmentation of labor will be studied with uterine EMG. The results of the EMG will be converted to an oxytocin-associated uterine stimulation index (uSI), which is intended to guide decisions for changing the dose of oxytocin. An expert panel will review the results of the oxytocin dosing actions, then assigned optimized actions throughout the labor. The uSI will be correlated with the optimal dosing actions.

Conditions

Pregnancy Related; Labor Long; Fetal Distress

Keywords

labor; oxytocin; tachysystole; prolonged labor

Outcome Measures

Primary Outcomes (2)

• Correlating uSI with the optimized dosing actions increase, hold and decrease

  uSI clustering with dosing actions will be identified to provide guidance when prospectively dosing oxytocin

  8 months

• Human factors in recording multichannel EMG during labor

  Difficulties and discomfort of the EMG recording process will be identified and corrected

  8 months

Study Arms (1)

Uterine EMG during labor

EXPERIMENTAL

Multichannel uterine electromyography will be recorded on patients receiving oxytocin for induction or augmenation of labor.

Device: uterine electromyography

Interventions

uterine electromyography DEVICE

Multichannel uterine electromyography will record uterine biosignals during labor.

Also known as: electrohysterography

Uterine EMG during labor

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: All subjects will be pregnant, hence will be women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 or greater
• At least 37 weeks gestation
• English reading and speaking
• Female gender
• Singleton fetus
• Planned continuous external fetal monitoring: to include fetal heart rate and uterine contraction monitoring
• May have clinical indications for internal monitoring (IUPC and/or FSE) that replaces external monitoring.
• Induction or augmentation of labor with oxytocin (Pitocin)
• Subjects undergoing artificial rupture of membranes (AROM) or who experienced spontaneous rupture of membranes (SROM), with a plan for oxytocin administration, will be included as a special category.
• Subjects may undergo cervical ripening.
• Patients must be able to review and sign informed consent to participate in the study.
• Trial of labor after Cesarean section are eligible for participation
• Women diagnosed with diabetes and/or pre-eclampsia with or without magnesium therapy are eligible for participation
• Women with other complications of pregnancy are eligible for participation if the complication does not interfere with fetal monitoring, EMG monitoring or other recording of data.

You may not qualify if:

• Non-English reading and/or speaking
• Twins, triplets and other multifetal gestations
• Non-vertex presentation
• Planned Cesarean delivery
• Significant uterine anomalies such as didelphys or bicornuate uterus (women with small, clinically insignificant anomalies such as uterine fibroids are not excluded).
• Participants cannot be participating in any other research study or protocol regarding uterine contraction monitoring during the same study period as required for our study.
• Known allergy to ECG pad adhesive
• Non-living fetus
• Major fetal malformation
• Fetal distress, or other indications for emergent delivery
• Other than a Category I fetal heart tracing at the beginning of the recording.

Sponsors & Collaborators

• PreTeL, Inc: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Fetal Distress

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Roger C Young, MD

CONTACT

16033598870; ryoung@pretelhealth.com

Marcus Finch

CONTACT

17708426806; mfinch@pretelhealth.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: prospective, non-significant risk

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 14, 2020
• Study Start: April 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: September 14, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)