Randomized trials needed for fetal surgery. (Safety and Efficacy a Concern).

SAN FRANCISCO -- The effectiveness of fetal surgeries has yet to be proven--and needs to be tested in randomized, controlled trials, Dr. Per Sandberg said at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco.

Several trials sponsored by the National Institutes of Health are now underway to evaluate some of the most common fetal surgeries, such as those for congenital diaphragmatic hernia (CDH), twin-to-twin transfusion syndrome (TTTS), and myelomeningocele, also known as spina bifida.

"Before these therapies become widespread, we must know more about their safety and efficacy," said Dr. Sandberg, a fetal surgeon at UCSF.

CDH is a condition in which a hole in the diaphragm allows the liver and intestines to invade the chest, causing pulmonary hypoplasia.

"The majority of fetuses that get liver up in the chest don't survive," Dr. Sandberg.

Early fetal surgeries for this condition were no more effective than standard postnatal care. But in 1996, when new laparoscopic and balloon procedures were developed, scientists believed it was time to test these operations in a randomized, controlled trial.

An NIH-sponsored trial in which 21 patients were randomized to either fetal surgery or standard postnatal care showed that both groups had equivalent survival rates--about 75%.