Indications, not device, blamed for VAD injuries. (Retrospective Study).

NEW ORLEANS -- Most injuries associated with vacuum-assisted delivery are not caused by the device but the indication for its use, results of a retrospective study of almost 400 cases showed.

Most serious perinatal injuries associated with vacuum-assisted delivery (VAD), including subgaleal hemorrhage, appear before delivery, said Dr. Barry Schifrin the study's principal investigator, at the annual meeting of the American College of Obstetricians and Gynecologists. "Our results suggest no inherent defect in the vacuum device.

The study expands on information in a 1998 advisory issued by the Food and Drug Administration, which warned that VAD devices may cause serious or fatal complications, including subgaleal hematoma and intracranial hemorrhage.

"The FDA study didn't have the benefit of any of this ancillary obstetrical information, and that's what we have tried to provide. They didn't know why the injuries occurred. They assumed every adverse outcome was related to the vacuum," Dr. Schifrin, director of the ob.gyn. residency program in maternal and fetal medicine at Glendale (Calif.) Adventist Medical Center, said in an interview.

In his study of 203 cases of adverse outcomes associated with VAD and 194 control VADs, there were marked differences in maternal, fetal, obstetric, and neonatal characteristics, Compared with controls, the cases had significantly larger fetuses, longer labors, and a higher incidence of occiput posterior position.

Adverse events in the cases included stillbirths, low Apgar scores, neonatal trauma, fetal acidosis, seizures, neonatal intensive care unit admission, Erb's palsy, cephaihematoma, subgaleal and other intracranial hemorrhages, neonatal death, and cerebral palsy

Using fetal heart rate tracings, Dr. Schifrin and his associates showed that in most cases fetal ...