Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia
ConditionShoulder Dystocia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFetalEase Ltd.
About 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
Qualifiers
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.
Disqualifiers
Patients who have undergone attempted delivery using ancillary standard of care maneuvers, to include first-line maneuvers (McRoberts ± suprapubic pressure with downward traction on the fetal head), prior to use of the Yaari Extractor. (NOTE: Hyperflexion of the hips or legs is allowed prior to and during use of the Yaari Extractor.)
Cesarean section is planned for the patient.
Obstetric contraindications to vaginal birth.
Subject carrying fetus with known significant chromosomal or structural anomalies.
Trial design
Treatments tested in this trial
- Yaari Extractor
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov