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Premature births may be reduced with hormone gel

April 06, 2011|By Marissa Cevallos, HealthKey

A simple, safe, relatively inexpensive hormone treatment might help some high-risk pregnant women carry their babies longer, a new study suggests, while improving the outlook for their infants. Such a treatment has been long sought.

Even better, the newest one would appear unlikely to cost $690 a dose — unless drug makers are slow learners.

Federal researchers, working with colleagues at 44 medical centers, found that administering vaginal progesterone to women with a short cervix — a risk factor for premature delivery — cuts the rate of delivering before 33 weeks by 45%.

The reduction applies only to women with a short cervix (between 1 centimeter and 2 centimeters), not for women at high risk for other reasons. But for these women, few medications have been found effective at keeping a baby in the womb longer. 

Physicians led by the National Institute of Child Health and Human Development in Bethesda, Md., assigned 458 women with a short cervix to receive daily applications of either a progesterone gel or a placebo gel between the 19th and 23rd weeks of pregnancy.  

Fewer women who got the progesterone treatment delivered early—8.9% versus 16.1% in the placebo group, the team reported online in the journal Ultrasound in Obstetrics and Gynecology. 

Further, there were indications the hormone might help the babies too. Fewer babies born to mothers given progesterone had respiratory distress syndrome, a lung disorder common to premature infants (3% versus 7.6%).

The data set isn’t very large: 21 of 235 women given progesterone delivered early compared with 36 of 223 women given a placebo. And, of course, the trial was funded by the maker of the progesterone gel, to be marketed as Prochieve.

But giving progesterone gel to 14 women with short cervical length would appear to prevent one premature birth, and a progesterone gel the company already sells, Crinone, is FDA approved for women in some fertility treatments. The researchers used about $20 worth of the 8% strength of Crinone in each dose. 

Thus, the findings are promising, especially when few drugs can keep a pregnant woman from delivering early.

One new drug, also progesterone-based, is marketed for women who have already had a spontaneous preterm birth. That drug, Makena, was the subject of considerable controversy recently after its manufacturer boosted the price from $20 per dose to $1,500 per dose before finally lowering it to $690. Makena, an injectable, is administered weekly. 

RELATED: Drug maker lowers price of Makena pregnancy drug to $690 per dose 

http://www.latimes.com/health/la-pn-makena-price-cut-fda-20110401,0,1076161.story

If the progesterone gel is as effective as the study suggests, women would likely find the price tolerable. But probably not at $690 a dose.

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