STORY BYResearcher Susan Ramin, M.D. admits up front that it is not a cure-all and they’re not even sure how it works.
But progesterone has proven to be so powerful in helping prevent pre-term births that two more National Institutes of Health studies involving the hormone are under way at The University of Texas Medical School at Houston.
That’s critical news for two high-risk groups of moms: those who have had premature babies before and those pregnant with multiples.
Premature infants, defined as those born before 37 weeks, are at risk for a host of problems including low birth weight, breathing difficulties and underdeveloped organs and organ systems. According to the National Institute of Child Health and Human Development, 8 to 10 percent of children born in the United States are premature. It is a leading cause of infant mortality.
The two new studies build on the 2002 results of an NIH trial that showed progesterone, specifically 17 alpha-hydroxyprogesterone (17-P), significantly reduced the risk of pre-term birth in women who had already had given birth to a pre-term baby.
Researchers, including Ramin, director of the Maternal-Fetal Medicine Division at UT Medical School, are now looking at a combination of Omega-3 and progesterone for women who have previously had a premature baby, and the effect of progesterone on women pregnant with twins or triplets. The UT Medical School at Houston is one of 14 sites nationwide involved in trials as part of the NIH Maternal-Fetal Medicine Unit Network.
“The future is very exciting,“ Ramin says. “We’re seeing hope. You take a patient who had a 25-week baby in a neonatal nursery and they’re very committed and motivated to try something that could prevent that adverse outcome. “
While researchers haven’t pinpointed how progesterone works, they know that levels of the hormone increase dramatically in pregnant women. Progesterone appears to help by relaxing smooth muscle and perhaps reducing inflammation, Ramin says. Doctors theorize that uterine inflammation is a risk factor for premature labor.
In the earlier study, a weekly injection of progesterone decreased the risk of pre-term delivery by 34 percent before the 37th week of pregnancy and 42 percent before the 32nd week. The benefits were so significant that the trial was halted early so that physicians could begin giving progesterone to women who are at high risk for delivering prematurely.
The hope is that the addition of Omega-3 fatty acid supplements will further decrease the rate of early deliveries. Omega-3, found in fish oil, has been shown in preliminary studies to suppress the production of inflammatory cytokines (proteins) that may trigger pre-term labor and the rupture of membranes.
Taking progesterone to another high-risk group—women pregnant with twins and triplets—was a logical next step. While there are other factors that cause pre-term delivery with multiples, such as the added stress on the uterus, there is still hope that progesterone will help.
That’s all that Nicole Meyers, 32, needed to know when she heard about the progesterone study while pregnant with twin boys. She and her husband, who also have a 5-year-old daughter, had been trying for a year to have another child when she became pregnant with twins.
“Because I work in the medical field, I know how important it is to participate in trials,” Meyers says. “I had heard so many horror stories about pre-term labor with multiples. If there was anything that could help, I was going to do it.”
Because the trial is a double-blind one, meaning that neither the patient nor the doctor knows if she received the placebo or progesterone, Meyers did not know for sure if she received progesterone. But she did very well, delivering her twins at Memorial Hermann Hospital in 2004 at 37 and three-fourths weeks. They weighed 5 pounds, 9 ounces and 5 pounds, 10 ounces and went home with her when she was discharged after a cesarean section.
Both studies are open to Houston women who meet the criteria, regardless of where they will deliver their babies. For information, call Brenda Cole, RN at 713-500-6454.
For the progesterone/Omega-3 double-blind study, women must have had a spontaneous previous pre-term delivery and be between 16 and 20 weeks pregnant. A spontaneous pre-term delivery is one for which there are no known causes. They will all be given progesterone up to 36 weeks and 6 days. In addition, half will receive the Omega-3 supplement and half will receive a placebo.
In the multiples study, women must be pregnant with twins or triplets and must be between 16 and 20 weeks along. Half will receive weekly shots of progesterone and half will receive shots of a placebo until week 36 and 6 days.
“Eventually, there probably will be a combination of things we do, “ Ramin says. “This is one piece of the puzzle. “
UPDATED: 1-09-2006
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Dr. Susan Ramin is director of the Maternal-Fetal Medicine Division at the UT Medical School.
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