Progesterone Gel Helps Prevent Preemies

April 8, 2011 2:12 PM

One in every 8 babies born in the US is premature. A new study (pdf/via) published online Wednesday in Ultrasound in Obstetrics and Gynecology indicates that vaginal progesterone gel can help women who are pregnant for the first time and at risk of premature birth extend their pregnancies, reduce potential complications and boost the health of their newborns.

"In women with a short cervix during the second trimester of pregnancy, use of a vaginal progesterone gel essentially halves the risk for preterm birth, according to an NIH- and industry-funded study published in Ultrasound in Obstetrics & Gynecology."

Previous, smaller-scale studies had produced conflicting, disparate results. The new study involved 32,000 pregnant women in the United States and nine other countries.

posted by zarq (18 comments total)

This is a sort of follow up to this post, except this study for the progesterone gel focused on first-time mothers, and the Makena progesterone caproate injections are (theoretically) for women who are at risk for premature birth but have previously had a child.
posted by zarq at 2:13 PM on April 8, 2011

"In women with a short cervix during the second trimester of pregnancy, use of a vaginal progesterone gel essentially halves the risk for preterm birth, according to an NIH- and industry-funded study published in Ultrasound in Obstetrics & Gynecology."

When they say "industry-funded" do they mean a specific pharma company that sells this, or do they mean like a foundation that lots of companies donate to and then they choose which NIH projects they want to invest in?

I apologize in advance for my naivete.
posted by anniecat at 2:30 PM on April 8, 2011 [1 favorite]

So, if it's a follow-up to that other post, important information I'd like to know is how much progesterone gel costs per dose, who holds the patent, and can compounding pharmacies create a similar product for pregnant women who need it?
posted by hippybear at 2:36 PM on April 8, 2011

anniecat, it looks like it was a Phase III study using either Crinone or Prochieve Progesterone Gel conducted in collaboration with "the Perinatology Research Branch (PRB) of the Division of Intramural Research of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH)." Collaboration in this case means the companies (there were two, even though only one is mentioned in the linked release) cooperated with the NIH and supplied all drugs at no cost. It is likely they also supplied the placebo, which would come in identical applicators filled with a non-progestin gel.

hippybear, Prochieve and Crinone is normally covered by insurance for any type of uterine bleeding or amenorrhea as long as it is not fertility-treatment related. Some insurance companies cover one but not the other. Some cover both, or none. I do not know if the gel would be covered in this case, but it seems more likely. (Insurance companies are often loathe to cover the cost of anything to do with fertility treatments because there's no guarantee of outcome.) In my experience, they're more likely to cover off-label uses of medications, such as Lovenox or indomethacine, during pregnancy.

Prochieve comes in two doses: a 4% or 8% concentration. (I believe Crinone does as well.) The dose used in the study was 8%, applied daily.

For women without insurance, the cost would still be high. With my wife, since our insurance didn't cover Prochieve, we paid about $200 out of pocket for a bunch of doses. I believe there were 18 in the pack. Which in this case would last less than a month. In women who are taking it for fertility reasons, you don't insert it daily, but every other day. So a single pack is good for at least one cycle of treatment.

Makena is injected once weekly, and will (now) cost $750 per dose. Assume Prochieve costs $240 for two to three weeks worth and you're looking at a substantial savings for anyone who does not have insurance. And of course, insurance is likely to cover it, so there's that. I believe Prochieve is covered by Medicare and Medicaid.

It's not cheap. But it's cheaper.
posted by zarq at 3:09 PM on April 8, 2011 [3 favorites]

Oops. I was wrong. I thought Crinone was made by Serono and Prochieve was made by Watson Pharmaceuticals. Both come from Watson. So one company, not two.

who holds the patent

No idea if there even is one. But if there I would guess it's held by Watson.

can compounding pharmacies create a similar product for pregnant women who need it?

Again, no idea. Capsules and injectibles of progesterone can be compounded. Dunno about gel.
posted by zarq at 3:22 PM on April 8, 2011

From this:

In a clinical study, certain complications or events associated with pregnancy occurred more often in women who received Makena compared to women who did not receive Makena, including:

Miscarriage (pregnancy loss before 20 weeks of pregnancy)
Stillbirth (fetal death occurring during or after the 20th week of pregnancy)
Hospital admission for preterm labor
Preeclampsia (high blood pressure and too much protein in your urine)
Gestational hypertension (high blood pressure caused by pregnancy)
Gestational diabetes
Oligohydramnios (low amniotic fluid levels)

I wish babies could be made and gestated in a lab, in some kind of see through structure you could visit every week or month until the timer goes off and you can pick it up. I've been reading all these "What they don't tell you about being pregnancy" and I've decided that I probably couldn't stand three months of pregnancy before driving to the nearest abortion clinic to get rid of it.

From my perspective, it sucks that a woman has to stay pregnant any longer than she would without the drug, but the pregnancy hormones have probably brainwashed her into doing everything for Master Baby so she will have to do everything she can to ensure a positive outcome for that little devil, even if it means terrible hemorrhoids.
posted by anniecat at 4:13 PM on April 8, 2011

who holds the patent

Since we know the proprietary names of two of the products (Crinone and Prochieve), the thing to do is look them up in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations database (aka the Orange Book). Drug makers are required to list any patents that cover their drugs, and that's where that information is kept. Crinone is covered by US patent 5,543,150, which will expire on September 15, 2013, according to the Orange Book. Watson is indeed the current patent holder.

Prochieve was purchased from Columbia Labs by Watson. It is not listed in the Orange Book.
posted by jedicus at 4:21 PM on April 8, 2011 [1 favorite]

anniecat, you are a pharma exec's dream come true.
posted by Stonestock Relentless at 4:33 PM on April 8, 2011

anniecat, you are a pharma exec's dream come true.

I doubt it since I loathe hormonal birth control too.
posted by anniecat at 4:50 PM on April 8, 2011

I wish babies could be made and gestated in a lab, in some kind of see through structure you could visit every week or month until the timer goes off and you can pick it up.

Shades of Brave New World and people being "decanted" rather than born.

Are you an Alpha? How pneumatic are you?

A gram is better than a damn.
posted by hippybear at 4:51 PM on April 8, 2011 [1 favorite]

Too soon?
posted by tapesonthefloor at 5:46 PM on April 8, 2011

Interesting. I was a 4lb baby and my sister was 3lb. I like that the goalposts have shifted sufficiently that that's now not remotely a cause for worry.
posted by kersplunk at 5:54 PM on April 8, 2011

I was born at 26 weeks (1 lb, 13 oz), and my brother was born at 30 weeks. So, it always excites me to see treatments like this that would potentially help manage difficult pregnancies.

kersplunk: Interesting. I was a 4lb baby and my sister was 3lb. I like that the goalposts have shifted sufficiently that that's now not remotely a cause for worry.

Those are still low birth weights, and while outcomes are improving all the time, there still would be some cause for concern.

Low birth weight =< 2500 g (5 lb, 8 oz).
Very low birth weight =<1>Source


posted by Harpocrates at 6:52 PM on April 8, 2011

Shades of Brave New World and people being "decanted" rather than born.

Are you an Alpha? How pneumatic are you?

A gram is better than a damn.

I've never read Brave New World, but I think it's reasonable to fear fissures, prolapsed uterus, tearing, pain, and all the other complications of pregnancy and birth that you have the luxury of being dismissive about. It's funny that you think you have any say in how a woman gets to feel about the prospect of being pregnant, unless you're willing to suffer an equal amount of bodily abuse and injury.
posted by anniecat at 9:18 AM on April 9, 2011 [3 favorites]

I heard about this on the radio yesterday. It's pretty cool, especially compared to the other treatments for prematurity (like bedrest, ugh).

anniecat, you are right, the stuff that pregnancy can do to a woman's body is pretty terrible. Or pretty nothing-at-all, it just depends on the woman and the pregnancy.

That said, this:

the pregnancy hormones have probably brainwashed her into doing everything for Master Baby so she will have to do everything she can to ensure a positive outcome for that little devil

was an extremely misogynistic statement. Pregnant women can still think for themselves, even their decisions aren't the ones that you would make.
posted by Leta at 9:37 AM on April 9, 2011 [1 favorite]

was an extremely misogynistic statement. Pregnant women can still think for themselves, even their decisions aren't the ones that you would make.

It's not a misogynistic statement. Given my later comment, it's very clearly tokophobic and tongue in cheek.
posted by anniecat at 11:46 AM on April 9, 2011

It's also probably misanthropic. I was going to say something about how pregnant women are pressured to do "what's best for the fetus" instead of themselves by both external and internal forces (husbands or fathers of the baby, other mothers and women, legislators, health care professionals, people at the grocery store), but I cut it out. It seemed a little long.
posted by anniecat at 12:00 PM on April 9, 2011

I haven't got time to read the whole paper now, but there's something fishy about this, beyond just the industry funding. UOG is some way off from being the best journal in O&G, and a very odd place to put a drug trial. They publish only ultrasound studies. Although this has an ultrasound component, it's not an ultrasound trial in the conventional sense. If this was as big a deal as the Scientific American were making out, it would have been accepted in New England Journal / Lancet / BMJ, or at the least one of the major obstetric journals.

One of the general problems with these trials is that although progesterones prolong pregnancy, they haven't been shown to improve mortality or long term morbidity. Although prescriptions of progesterones have become very widespread in the US, OBGYNs in Europe are much more circumspect about their use, because the long term efficacy data is still missing, and the safety hasn't really been tested at all.
posted by roofus at 3:25 AM on April 10, 2011 [1 favorite]