Progesterone to curb preterm birth.(News)

With proper informed consent, the prescription of progesterone to prevent preterm birth in appropriate patients should not put physicians at increased risk of liability, according to several experts.

In fact, physicians may face a lawsuit if they fail to offer it when indicated, suggested Steve Caritis, M.D.

"You can envision a woman who has had two previous preterm births and her physician doesn't raise this option. If she has another preterm birth there could be liability for not informing her that the therapy exists," he said in an interview.

Dr. Caritis, professor and chief of maternal-fetal medicine at the University of Pittsburgh, was one of the investigators in the key study that led to the endorsement of progesterone therapy by the American College of Obstetricians and Gynecologists as a means of preventing preterm birth (ACOG Committee Opinion #291 [Obstet. Gynecol. 2003;102:1115-6]).

The randomized, placebo-controlled trial, conducted for the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network, found that weekly intramuscular injections of 250 mg of 17 [alpha]-hydroxyprogesterone caproate (17P) decreased the risk of preterm birth by 34% in women with a history of at least one spontaneous preterm birth (N. Engl. J. Med. 2003;348:2379-85).

ACOG's endorsement of the therapy stresses the importance of restricting it to this very select group of high-risk patients. The opinion notes that the drug "has been studied only as a prophylactic measure in asymptomatic women, not as a tocolytic agent," and that further studies are needed to evaluate its use in women with multiple gestations, short cervical length, or positive test results for cervicovaginal fetal fibronectin. It also mentions that both the optimal route of drug delivery and its long-term safety remain unknown.

Given such unresolved issues, it is reasonable for physicians to have concerns about liability, but this shouldn't deter them from prescribing the therapy where appropriate, said Larry Veltman, M.D., chair of ACOG's Committee on Professional Liability and chair of the department of obstetrics and gynecology at Providence St. Vincent Medical Center in Portland, Ore.