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New 17-OHPC TrialFrom: Efrain Ramirez (eramirezt@coqui.net)Thu Mar 8 15:04:01 2007
No Drop in Preterm Births of Twins in New 17-OHPC Trial: Drug also failed to reduce fetal death rate. SHERRY BOSCHERT (San Francisco Bureau) Article Outline • Copyright SAN FRANCISCO — Weekly injections of 17-hydroxyprogesterone caproate failed to reduce preterm delivery or fetal death in a randomized, controlled study of 655 twin pregnancies. Investigators had hoped to see a repeat of results from a 2003 study showing that 17-hydroxyprogesterone caproate (17-OHPC) injections reduced the risk of preterm birth in singleton pregnancies in women with a prior preterm birth, Dr. Steve N. Caritis reported at the annual meeting of the Society for Maternal-Fetal Medicine. In the current study, healthy women with twin pregnancies and an established gestational age of 16–20 weeks received either 250 mg 17-OHPC or placebo weekly until delivery or until the end of week 34. The rate of fetal death or delivery before 35 weeks was 42% in the 17-OHPC group and 37% in the placebo group, not a statistically significant difference, said Dr. Caritis, professor of ob.gyn. and reproductive sciences at the University of Pittsburgh. He conducted the study with Dr. Dwight Rouse in 14 centers of the Maternal-Fetal Medicine Units Network of the National Institute of Child Health and Human Development. Dr. Rouse is professor of ob.gyn. at the University of Alabama, Birmingham. At any given time after randomization, the likelihood of both fetuses being alive was nearly identical between groups, he added. The study included fetal death in the primary outcome along with gestational age at delivery because in twin pregnancies one fetus can die while the other continues to delivery. The mean gestational age at birth was 37 weeks in the treatment group and 35 weeks in the placebo group, a nonsignificant difference. Secondary outcomes also did not differ significantly, including fetal death or delivery before 32 weeks (17% of the 17-OHPC group vs. 14% of the placebo group). No significant differences between treatment groups were seen in rates of fetal death or preterm birth when analyzed by subgroups of spontaneous or indicated deliveries, monochorionic or dichorionic twins, or spontaneous or assisted conception. Dr. Caritis suggested two reasons why results of the trial differed from the singleton trial. The mechanism of preterm birth may be different in twin and singleton pregnancies, or the dose used in both studies may be adequate for singleton gestations but inadequate for twins. Both trials used the same formulation of 17-OHPC made by the same compounder. A composite of serious fetal or neonatal outcomes was similar between groups, affecting 20% in the 17-OHPC group and 18% in the placebo group. Individual neonatal outcomes were similar between groups. Rates of serious neonatal outcomes were no higher than expected in either group. Baseline demographics were similar between groups. Of 661 patients randomized, 6 were lost to follow-up—2 in the treatment group and 4 in the placebo group. The study had a greater than 80% power to detect a 33% difference in the rate of fetal death or preterm delivery. In the United States, the number of twin pregnancies per year nearly doubled in 1980–2004, from about 70,000/year to about 135,000/year. Twins now comprise about 3% of all births, 13% of deliveries at less than 35 weeks, and 18% of deliveries at less than 32 weeks. Twin gestations increase uterine stretch, which increases contractile-associated proteins. Progesterone inhibits formation of contractile-associated proteins. Because 17-OHPC has a longer-lasting, more potent progestational effect than does progesterone, it is considered attractive to researchers.
-- “ The greatest obstacle to knowledge is not ignorance, it is the illusion of knowledge.” Daniel J. Boorstin - Historian
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