General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT05913609

Background Information

The Yaari Extractor Investigational Device is intended for treatment of shoulder dystocia (SD). The purpose is to create a more effective and controlled response to SD compared to the current standard of care. Furthermore, to decrease risks and complications to mother and baby.

For additional information, please visit:

https://clinicaltrials.gov/study/NCT05913609

Offered At

Department of Obstetrics and Gynecology
Inova Fairfax Hospital
3300 Gallows Road
Principal Investigator

Scott Sullivan, MD

Eligibility Information

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

  • Subject planning on vaginal birth.
  • Singleton pregnancy in vertex presentation. 
  • Full-term pregnancy having completed 37-weeks or more gestational weeks.
  • Able and willing to provide written informed consent prior to enrollment. 
  • In the opinion of the Investigator, the subject has sufficient mental capacity to understand the informed consent form (ICF). 
  • 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."

Ineligibility Information

Patients who have undergone ancillary standard of care maneuvers, to include first-line maneuvers (McRoberts/suprapubic pressure), prior to use of the Study Device.

  • Cesarean section is planned for the patient.
  • Obstetric contraindications to vaginal birth.
  • Subject carrying fetus with known significant chromosomal or structural anomalies.
  • Clinically estimated fetal weight ≥5kg in non-diabetic subjects.
  • Clinically estimated fetal weight ≥4.5kg in subjects with diabetes.
  • Subject has any general health condition or systemic disease that may represent, in the opinion of the Investigator, a potential increased risk associated with device use or pregnancy.
  • Bleeding disorders, such as thrombocytopenia, von Willebrand's disease, current use of anticoagulation  medication, etc.
  • Any maternal disease or disorder that precludes the subject from pushing effectively. 
  • If the maternal cervix is not fully dilated.
  • If the fetal head is not completely out of the birth canal.
  • In the presence of a non-reducible nuchal cord.