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Procedure

Yaari Extractor for Shoulder Dystocia

N/A

Recruiting

Research Sponsored by FetalEase Ltd.

Eligibility Criteria Checklist

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

Must have

Subject 18 years of age or older at time of consent.

Subject with fetus experiencing shoulder dystocia as defined by ACOG Practice Bulletin 178 "Shoulder dystocia is most commonly diagnosed as failure to deliver the fetal shoulder(s) with gentle downward traction on the fetal head, requiring additional maneuvers to effect delivery."

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately after the intervention

Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a medical tool for shoulder dystocia used by US OB/GYNs.

Who is the study for?

This trial is for adults over 18 who are at least 37 weeks pregnant, expecting a single baby in head-down position, and planning a vaginal birth. It's specifically for those experiencing shoulder dystocia during delivery—a condition where the baby's shoulder gets stuck after the head is born. Participants must understand and agree to the study.Check my eligibility

What is being tested?

The Yaari Extractor—a device designed to help safely deliver babies when shoulder dystocia occurs—is being tested by OB/GYNs across multiple centers. The study compares its safety and effectiveness against past methods used for this complication.See study design

What are the potential side effects?

While specific side effects aren't listed here, using any medical device during childbirth could potentially cause tissue trauma or injury to mother or baby. The trial aims to ensure that the Yaari Extractor minimizes such risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My baby experienced shoulder dystocia during delivery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after the intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after the intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after the intervention for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Maternal and neonatal adverse events

Number of successful neonate deliveries with the Yaari Extractor device

Time interval (minutes) from the diagnosis of the shoulder dystocia until the neonate's delivery

Secondary outcome measures

Ease of Use 5 point Likert scale User Questionnaire

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Yaari Extractor groupExperimental Treatment1 Intervention

Prospective experimental arm

Group II: Control groupActive Control1 Intervention

Historical control arm - retrospective review of medical records at the same study sites

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

FetalEase Ltd.Lead Sponsor

Frequently Asked Questions

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

How many volunteers are currently involved in this experiment?

"Affirmative. According to the clinicaltrials.gov, this medical trial was first uploaded on November 15th 2023 and is actively seeking 80 participants at one location for further study."

Answered by AI

Are there any patient vacancies for this experimental endeavor?

"Verified. According to the clinicaltrials.gov database, this trial first appeared on November 15th 2023 and was most recently updated on November 21st 2023; it is now looking for 80 participants from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia

2023. "Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05913609.