The preterm birth crowd has been abuzz about progesterone because this very old drug has been proven to prevent preterm birth. First, weekly injections of 17-hydroxyprogesterone caproate (17-P) were shown to prevent a repeat preterm delivery, and more recently, vaginal progesterone was shown to prevent preterm delivery in women with a short cervix noticed on ultrasound in the second trimester.
I have enjoyed writing about the sleazy (and not so sleazy) companies that have tried to cash in on these discoveries, but the good news is that we now have a proven treatment to prevent preterm delivery in certain categories of patients.
The reason it took obstetricians decades to prove the value of progesterone -- the idea that the drug prevents preterm delivery is at least 40 years old -- has everything to do with research. It took courageous investigators to assemble large clinical trials with strict entry criteria to demonstrate this medication's effect in well-selected groups of patients.
This lesson was not lost on a group of Spanish researchers who conducted a carefully-designed study on an appropriately-selected group of women using another very old technique to prevent preterm birth.
In this excellent study, published in the prestigious British journal The Lancet, obstetricians at five Spanish hospitals randomized 385 women with a short cervix to use of pessary or nothing. Pessaries are centuries-old devices that women place in their vagina to support their uterus and pelvic organs and prevent symptoms of pressure when these organs "fall" (prolapse) typically later in life. A handful of small studies using pessaries to prevent preterm delivery (the idea is that the pessary supports the cervix or lower uterus) have been published over the past 50 years, but none has had the size or scientific rigor to convince the obstetric community.
In their study, the Spanish group used the Dr. Arabin pessary, named after the German scientist who developed it, which looks like a tiny inverted cereal bowl with a whole cut in the center of it. The Dr. Arabin pessary is approved for sale in Europe but not in the U.S.
So now what? If history is any guide, the Lancet paper will encourage other scientists to study the Dr. Arabin pessary as well as other pessaries, to see if they can repeat the results of the Spanish trial, and to determine if the pessary works to prevent preterm delivery for other categories of women than were studied in Spain.
In the United States, there is a bit of a catch-22 situation. It doesn't make much sense to study the Dr. Arabin pessary, because this pessary isn't approved by the FDA for sale in the U.S., and yet it doesn't make much sense to study the use of other pessaries when the Dr. Arabin pessary has the weight of the Lancet study behind it.
So here, gentle readers, is my humble suggestion:
- No one is going to make a lot of money selling pessaries, so this is going to take some kind of partnership between a medical device company with very patient shareholders and an entrepreneurial philanthropy. That may work out well, because the Dr. Arabin pessary is produced in small quantities by its namesake's idealistic daughter, Dr. Birgit Arabin, who told me, "I am happy with the idea that I can help a lot of people."
- Then it's going to require a large American clinical trial, because physicians the world over (and the all-important Food and Drug Administration) are notoriously snobby when it comes to medical devices and tend to insist on proof from a population of Americans.
But it's worth it, because the consequences of preterm birth are an enormous burden of lifelong disability the world over, and we need another tool in our kit besides progesterone.
For more by Adam Wolfberg, M.D., click here.
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