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Electrical Device

Electrical Uterine Pacemaker for Preterm Birth

N/A

Recruiting

Led By John Smulian, MD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from 20, 40, and 80 minutes

Awards & highlights

Study Summary

This study is evaluating whether a new device can help stop uterine contractions in pregnant women.

Eligible Conditions

Preterm Birth
Preterm Labor

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from 20, 40, and 80 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from 20, 40, and 80 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from 20, 40, and 80 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Uterine contraction frequency during labor as measured by external uterine tocodynamometric monitoring

Secondary outcome measures

EHG monitoring as measured by LaborView Device

EMG monitoring as measured by LaborView Device

FHR pattern as measured by the maternal-fetal monitor

+3 more

Other outcome measures

Adverse events

Trial Design

3Treatment groups

Experimental Treatment

Group I: 80 Minute StudyExperimental Treatment1 Intervention

After a 20-minute pre-intervention control period the electrical inhibition will be used intermittently, only when there is monitored contraction, during the 40-minute intervention study period. At the end of the intervention period there will be a 20-minute post-intervention control period. The FHR patterns, tocogram, EMG and EHG, and fECG recordings will be compared to before and after the use of the electrical uterine pacemaker device.

Group II: 60 Minute StudyExperimental Treatment1 Intervention

After a 20-minute pre-intervention control period the electrical inhibition will be used intermittently, only when there is monitored contraction, during the 20-minute intervention study period. At the end of the intervention period there will be a 20-minute post-intervention control period. The FHR patterns, tocogram, EMG and EHG, and fECG recordings will be compared to before and after the use of the electrical uterine pacemaker device.

Group III: 120 Minute StudyExperimental Treatment1 Intervention

After a 20-minute pre-intervention control period the electrical inhibition will be used intermittently, only when there is monitored contraction, during the 80-minute intervention study period. At the end of the intervention period there will be a 20-minute post-intervention control period. The FHR patterns, tocogram, EMG and EHG, and fECG recordings will be compared to before and after the use of the electrical uterine pacemaker device.

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Who is running the clinical trial?

E-BIO CORPUNKNOWN

Convergent EngineeringUNKNOWN

University of FloridaLead Sponsor

1,340 Previous Clinical Trials

715,586 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What qualifications are necessary for a person to participate in this medical study?

"The requirements for this medical trial necessitate that individuals of ages 18 to 50, who have experienced a premature birth in the past, are eligible. Approximately 110 participants will be inducted into the study."

Answered by AI

Does the age restriction for this research extend beyond 75 years of age?

"This trial only accepts participants between 18 and 50 years old. However, there are alternative clinical trials available for minors (186) as well as elderly individuals(77)."

Answered by AI

Are there still patient openings for this investigation?

"Affirmative. Clinicaltrials.gov documents that the study, which was inaugurated on March 1st 2017 and most recently updated on November 17th 2022, is currently enrolling participants with a goal of 110 individuals from a single site."

Answered by AI

What is the cap on participants for this research project?

"Absolutely. Per clinicaltrials.gov, the trial in question is accepting participants - first published on March 1st 2017 with an update most recently made November 17th 2022. 110 patients are being recruited from one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Electrical Inhibition of Human Preterm Contractions

2017. "Electrical Inhibition of Human Preterm Contractions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02983240.