80 Participants Needed

Yaari Extractor for Shoulder Dystocia

Recruiting at 2 trial locations
AS
Overseen ByAhava Stein
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using anticoagulation medication for a bleeding disorder, you may not be eligible to participate.

What data supports the effectiveness of the treatment Yaari Extractor for shoulder dystocia?

The Yaari Extractor is designed to help guide the baby's shoulder during delivery, which can be crucial in cases of shoulder dystocia (when the baby's shoulder gets stuck during birth). While specific effectiveness data for the Yaari Extractor is not provided, similar instruments have been developed to assist in such situations, suggesting potential value in managing this complication.12345

What makes the Yaari Extractor treatment unique for shoulder dystocia?

The Yaari Extractor, also known as the FetalEase Device, is unique because it is a mechanical device designed to assist in the delivery process by providing a safe and controlled way to manage shoulder dystocia, a condition where the baby's shoulder gets stuck during birth. Unlike traditional methods that rely on manual maneuvers, this device offers a novel approach by potentially reducing the risk of injury to both the mother and baby.678910

What is the purpose of this trial?

Prospective, multi-center, single arm with historical control, to verify the safety and effectiveness of the Yaari Extractor used by board certified or board eligible U.S. OB/GYN physicians in the management of shoulder dystocia.

Eligibility Criteria

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.

Inclusion Criteria

You are planning to give birth vaginally.
I understand the consent form for this study.
You are pregnant with only one baby positioned head-down.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive the Yaari Extractor intervention for management of shoulder dystocia

immediate
1 visit (in-person)

Follow-up

Participants are monitored for maternal and neonatal adverse events

5 days

Treatment Details

Interventions

  • Yaari Extractor
Trial Overview 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.
Participant Groups
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

Yaari Extractor is already approved in United States for the following indications:

🇺🇸
Approved in United States as Yaari Extractor for:
  • Management of Shoulder Dystocia

Find a Clinic Near You

Who Is Running the Clinical Trial?

FetalEase Ltd.

Lead Sponsor

Trials
1
Recruited
80+

Findings from Research

The Yaari Extractor is a new single-use device designed to assist in vaginal delivery during shoulder dystocia, successfully used in three cases without the need for additional obstetric maneuvers.
In all instances, the device resolved the shoulder dystocia effectively, with no reported injuries to either the mother or the fetus, indicating its safety and efficacy.
An Extractor for the Management of Shoulder Dystocia.Gherman, RB., Patel, R.[2023]
The use of a vacuum extractor during delivery is associated with a significantly higher risk of shoulder dystocia (SD) compared to spontaneous vaginal delivery, with odds ratios of 2.87 and 2.98 in different models.
There is no significant difference in the occurrence of shoulder dystocia between vacuum and forceps deliveries, indicating that while vacuum delivery increases risk compared to spontaneous delivery, it does not pose a greater risk than forceps.
Does vacuum delivery carry a higher risk of shoulder dystocia? Review and meta-analysis of the literature.Dall'Asta, A., Ghi, T., Pedrazzi, G., et al.[2017]
In a study of 107 medical records, shoulder dystocia was frequently associated with high fetal weights, with 75% of cases involving babies weighing over 4,000 grams, indicating that macrosomia is a significant risk factor for fetal injuries during delivery.
Almost one-third of the cases resulted in permanent hypoxic or traumatic cerebral damage, highlighting the serious consequences of shoulder dystocia, especially when instrumental delivery methods like forceps or vacuum extraction were used.
Common intrapartum denominators of shoulder dystocia related birth injuries.Iffy, L., Varadi, V., Jakobovits, A.[2016]

References

An Extractor for the Management of Shoulder Dystocia. [2023]
Does vacuum delivery carry a higher risk of shoulder dystocia? Review and meta-analysis of the literature. [2017]
Common intrapartum denominators of shoulder dystocia related birth injuries. [2016]
A new instrument for the management of shoulder dystocia. [2019]
Intrapartum interventions for preventing shoulder dystocia. [2022]
Potential use of a combined extractor in intravascular procedures. [2016]
Total endoscopic thyroidectomy via a unilateral axillo-breast approach with two spatula-shaped wires each attached to the end of an endoscopic aspirator and a retractor-shaped wire. [2018]
Nerve and tendon approximator. [2009]
Endoscopic removal of foreign bodies using a newly developed extractor. [2004]
10.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Vein extractor]. [2006]
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