- The Washington Times - Thursday, February 6, 2003

SAN FRANCISCO, Feb. 6 (UPI) — A controversial progesterone therapy could dramatically reduce recurrent premature birth in women at high risk, new research disclosed Thursday concludes.

Previous studies have cast doubt on the benefits of the therapy but this research — presented at the annual meeting of the Society for Maternal-Fetal Medicine — has reopened the debate on progesterone's role in preventing pre-term births.

The therapy involves weekly injections of 17 alpha-hydroxyprogesterone, or 17P, a progesterone-derived hormone. In a study sponsored by the National Institute of Child Health and Human Development — part of the National Institutes of Health in Bethesda, Md. — 19 maternity centers nationwide enrolled 500 subjects who were randomized into two groups. The first received 36 weekly injections of 17P, and the other received only a placebo.

"Weekly injections of 17P provided significant and powerful protection against recurrent pre-term birth in women at high risk," said study lead author, Dr. Paul Meis, of the NICHD.

Meis said the results were so impressive the researchers felt ethically compelled to halt their trial and make their findings public.

"The bottom line is that women who were treated had about a 30 percent reduction in having a pre-term delivery compared to a placebo," said Dr. Nancy Green, medical director of the March of Dimes, "and this was a very well-designed clinical study."

The results are good news to clinicians because the causes of pre-term birth are poorly understood and researchers have found few interventions effective in preventing ever-increasing rates of premature delivery.

The efficacy of 17P is particularly surprising because it is an old drug that has languished on storage shelves for decades, researchers said.

Because the patent on the drug has long-expired, 17P is of little interest to the pharmaceutical industry. The study required public funding in order to resurrect it from the dust heap of clinical research.

"This is a beautiful study. The network of institutions working together with public health support made it possible," Dr. Emile Papiernik of the Assistance Public Hospital in Paris, told United Press International. "There may be resistance to the findings — people don't like old ideas and the pharmaceutical industry may block it because there's no money in this drug," he added.

Enthusiastic supporters of the findings such as Papiernik wonder who will manufacture the drug, given its low profit potential. Moreover, past hormone therapies, such as diethylstilboestrol — also known as DES — which was thought to prevent miscarriage, but later proved to be a tremendous liability to the manufacturer when the drug was implicated in causing birth defects.

Still, a therapy that shows this much initial promise is extremely exciting to physicians and researchers who have been largely stumped by the rising tide of pre-term births. The trend is particularly disturbing, they said, because babies born before the termination of the full 40-week gestation period face a higher risk for slow mental development and physical disabilities.

"What's really remarkable is that these are women who had a previous pre-term birth and those women are at a much greater risk for another pre-term birth. This is a group that has been really unresponsive to treatment," Green told UPI.

Because 17P is experimental and not currently available to the public, Green suggested women interested in receiving the new therapy contact the study centers about enrolling in a clinical trial.

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