Hormone Treatment May Drastically Reduce Preterm Births
Huge Drop Seen in Women Given Progesterone
FDA to Consider Progesterone Treatment continued...
On Jan. 20, 2012, the FDA will consider an application jointly submitted by Columbia Laboratories and Watson Pharmaceuticals to approve a vaginal progesterone gel for prevention of preterm labor. The FDA is expected to decide by late February 2012, says Charlie Mayr, a spokesperson for Watson Pharmaceuticals.
Mayr couldn't disclose costs of the new gel, which may be called Prochieve.
One of the study’s researchers, John O'Brien, MD, was involved in vaginal progesterone studies sponsored by Columbia Laboratories. He also serves on advisory boards and is a consultant for Watson Pharmaceuticals. He is listed on the patent for the use of progesterone to prevent preterm birth.
Vaginal Progesterone Treatment a Game Changer?
The new findings ''will cause a change in practice," says Jill Rabin, MD, chief of ambulatory care, obstetrics, and gynecology, and head of urogynecology at the Long Island Jewish Medical Center in New Hyde Park, N.Y.
She reviewed the findings but was not involved in the research.
She calls the reduction in preterm births significant.
The recommendation to obtain routine ultrasounds ''doesn't add much in the way of cost," Rabin tells WebMD. The ultrasounds are routinely given to assess the pregnancy.
Women should know the status of their cervix when pregnant, Rabin says. "During prenatal care, it's important to discuss the length of the cervix with your physician. If a doctor doesn't discuss it, ask: 'Does my cervix look OK?'"