Studies show the benefits of progesterone therapy to help prevent preterm births like this "preemie" born 8 weeks early & weighing about 4 lbs.
Every year in the United States, half a million babies are born prematurely.
Researchers have identified a therapy that has the potential to prevent thousands of these early deliveries.
The drug is 17 Alpha-hydroxyprogesterone caproate, known as 17P.
Preterm deliveries rising
About 8 percent of babies born earlier than the 37th week of pregnancy will have a birth
defect according to the research by a team of investigators from the March of Dimes, the U.S. Centers for Disease Control and Prevention (CDC), and several other major institutions.
one knows the causes, but the rate of premature deliveries in the United States is rising. A National Center for Health Statistics report, Births: Final data for 2006, National Vital Statistics Reports; Vol. 57, No. 7, shows that the preterm birth rate rose to 12.8 percent in 2006 a 36 percent increase since the early 1980s.
17P is effective
One study, reported in the New England Journal of Medicine (N Engl J Med 2003; 348:2379-85), showed that 17P treatment reduced preterm birth by 34 percent in women pregnant with a single baby who had a previous preterm delivery (one
indicator of high risk for early labor in following pregnancies).
who received weekly 17P injections starting at 16 to 20 weeks gestation had a significantly reduced risk of preterm delivery compared to women who received placebo injections. Infants whose mothers were treated with 17P also had significantly
lower rates of severe complications.
The children of the women who participated in the 2003 NIHCD showed no significant difference in the frequency of genital malformations between children who had
been exposed in utero to 17P and children whose mothers had been given placebo. A follow up study of these children at 4 years showed that height, weight, head circumference, blood pressure, neurodevelopment, and scores for gender specific roles were comparable between the two groups
How does 17P work?
Researchers are not absolutely certain why the progesterone based treatment works. They do
know that in most mammals, progesterone is produced by the placenta during pregnancy.
Medical researchers believe that this hormone helps keep the uterus in a quiescent
state preventing the contractions that lead to labor.
drop in the blood level of progesterone results in uterine contractions and labor
(J Soc Gynecol Invest 2002; 9:125-36). It seems that supplementing the levels
of progesterone, by administering 17P to women who are experiencing early labor,
helps to keep the uterus from contracting and, in many cases, delays labor until
the baby is safe.
is normally prescribed as a series of shots given weekly. The treatment begins
between the 16th and 21st week of pregnancy. Multiple studies have found that
women who received at least five injections of 17P, experienced a statistically
significant reduction in NICU admissions and in preterm births.
does not prevent preterm deliveries with multiples
who are pregnant with twins or multiples should not take 17P. Despite the low
risk for side effects, it has not been shown to be more effective than a placebo
in reducing the risk of preterm labor with multiples. Only women with a singleton
pregnancy and who have a history of a previous singleton spontaneous preterm birth
between 20 and weeks gestation are good candidates for 17P treatments.
17P is not effective in preterm delivery with twins
Does this help prevent early delivery due to incompetent or short cervix?
Doctors and researchers are uncertain about whether progesterone therapy should be used
with women who are in danger of early labor due to problems with the cervix. A
2007 study found that daily vaginal administration of 200 mg of progesterone reduced
the rate of delivery before 34 weeks from 34% to 19% in women with a short cervix
(N Eng J Med. 2007;357:462-469). The data is inconclusive and some recent studies
have not found significant results. The American College of Obstetricians and
Gynecologists allows 17P therapy for women with an incompetent or short cervix since there is a chance that the treatments will help and the risk of serious
side effects is small.
studies suggest a procedure called cerclage, where the doctor puts a stitch in
the cervix to help keep it closed until the baby is able to thrive outside the
uterus (usually around the 37th week), may help reduce the risk of preterm delivery
in some women who have cervical abnormalities and have had a previous preterm
is the 17P treatment administered?
progesterone preparation known as 17P is available only by prescription from compounding
pharmacies that compound sterile products. It is normally dissolved in an oil
suspension and given as a weekly shot into the muscle of the buttocks. !7P is
also available as suppositories, although there is not enough research to determine
whether that route is as effective as the injection.
there any side effects of 17P therapy?
amount of progesterone produced during a normal pregnancy, mainly by the placenta,
is greater than the pharmacologic doses employed in 17P treatments. Reported side
effects in the mother have included swelling, itching and other local reactions
at the site of the injection, hypersensitivity reactions, cough, dyspnea, and
an increased risk of developing gestational