Yaari Extractor for Shoulder Dystocia

Recruiting at 2 trial locations

Overseen By Ahava Stein

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: FetalEase Ltd.

Must not be taking: Anticoagulants

Disqualifiers: Planned cesarean, Fetal anomalies, Diabetes, Bleeding disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: immediate

80 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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.

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

Group I: Yaari Extractor group Experimental Treatment 1 Intervention

Prospective experimental arm

Group II: Control group Active Control 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Common intrapartum denominators of shoulder dystocia related birth injuries. Iffy, L., Varadi, V., Jakobovits, A.[2016]

Shoulder dystocia is a rare but serious complication during childbirth, occurring in about 1 in 10,000 deliveries, making it difficult for individual obstetricians to gain sufficient experience for effective management.

The author has developed a new obstetric instrument called the 'shoulder born' that may help manage shoulder dystocia by creating a channel to facilitate the delivery of the anterior shoulder, potentially reducing trauma during the process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new instrument for the management of shoulder dystocia. Chavis, WM.[2019]

Prophylactic manoeuvres, like the McRobert's manoeuvre, may reduce the incidence of shoulder dystocia during childbirth, as indicated by one study showing fewer cases in the prophylactic group compared to the control group (RR 0.44).

However, the use of these manoeuvres was associated with a higher rate of caesarean sections, suggesting that while they may help prevent shoulder dystocia, they could also lead to more surgical interventions during delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intrapartum interventions for preventing shoulder dystocia. Athukorala, C., Middleton, P., Crowther, CA.[2022]

The development of a new combined extractor allows for both central and lateral grasping techniques, enhancing the effectiveness of endovascular procedures.

This extractor is particularly useful for removing foreign bodies, such as catheters, which can improve patient outcomes during complex medical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential use of a combined extractor in intravascular procedures. Sochman, J., Peregrin, JH.[2016]

The new retractor-shaped and spatula-shaped wire devices developed for total endoscopic thyroidectomy were used safely in 18 patients, with no cases of hemorrhage or conversion to open surgery, indicating their effectiveness in maintaining surgical safety.

These devices allowed for successful procedures on larger thyroid lesions and patients with previous thyroid surgeries or conditions like Graves' disease and chronic thyroiditis, demonstrating their versatility in complex cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Luangchana, V.[2018]

A new device made from a plastic syringe and two needles provides a safe and effective way to approximate severed nerves or tendons without tension, which is crucial for proper healing.

This practical tool simplifies the process of nerve or tendon repair, potentially improving outcomes in surgical procedures involving these structures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nerve and tendon approximator. Bayramiçli, M., Gürünlüoğlu, R., Yilmaz, B., et al.[2009]

The new endoscopic extractor for foreign body removal has demonstrated successful use, allowing for 360-degree rotation to grasp objects from any angle.

This device utilizes a band-like snare with tiny studs for effective capture and extraction, ensuring a quick and safe procedure for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic removal of foreign bodies using a newly developed extractor. Hennig, AE., Seuberth, K.[2004]

The proposed veinextractor is designed specifically for the dissection and extraction of varicose and thrombosed veins in the lower limbs, featuring a unique head shape that minimizes trauma during the procedure.

Using this veinextractor has resulted in reduced tissue damage and improved cosmetic outcomes for patients undergoing vein removal surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Vein extractor]. Komarov, IA., Romanovskiĭ, AV.[2006]

References

1. United States pubmed.ncbi.nlm.nih.gov

An Extractor for the Management of Shoulder Dystocia. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

Does vacuum delivery carry a higher risk of shoulder dystocia? Review and meta-analysis of the literature. [2017]

3. Germany pubmed.ncbi.nlm.nih.gov

Common intrapartum denominators of shoulder dystocia related birth injuries. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

A new instrument for the management of shoulder dystocia. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Intrapartum interventions for preventing shoulder dystocia. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Potential use of a combined extractor in intravascular procedures. [2016]

7. Thailand pubmed.ncbi.nlm.nih.gov

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]

8. United States pubmed.ncbi.nlm.nih.gov

Nerve and tendon approximator. [2009]

9. Germany pubmed.ncbi.nlm.nih.gov

Endoscopic removal of foreign bodies using a newly developed extractor. [2004]

10. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Vein extractor]. [2006]