p17 shots questions

[APToddlerMama]

My OB has suggested that I start up p17 shots at 16 weeks as my son was born at 35 weeks due to placental abruption.  I haven't been able to find any info on the shots helping with abruption and there are plenty of side effects so I'm considering declining. I don't know, but I'm guessing my preterm labor was due to the abruption.  Is anyone else doing them this pregnancy or have you done them in the past?  What was the reason?  TIA! 

xposted in my DDC

[by-the-lake]

Hi! Interesting you should ask this. I too had my son at 35 weeks, cause unknown. I asked my OB who specializes in high risk pregnancy if I was a canidate for P17
. He said that the studies showed only a slight increase of decreased preterm labor with P 17 verses oral Prometruim. I am currently taking oral Prometruim until week 35. Anyhow, his rational was that the slight increase of decreased preterm labor was not worth the pain and possible risk of infection with weekly intramuscular injections. Also, the FDA has just given a patent to a private company who has raised the price from about $20 per injection to like $ 1500. The drug was previously made by special formulary prior to this.
I am not sure how this fits into your situation with placental abruption. Did the abruption cause preterm labor? Was it an incidental find? How did your son do?

[dashley111]

I take progesterone from weeks 16 to week 34.  I use suppositories, which are applied right to the cervix- same dose as the injections but the cost is only a fraction.  I had GREAT success with my last pregnancy, after having preterm labor at 28 weeks with my first and being hospitalized until week 34 when I gave birth.  Even though I had a good amount of preterm contractions with my second child my cervix never changed, and my placenta never detached- and I credit it to the progesterone. 

I had been wondering if there was anyone else around who used progesterone outside of the first trimester. It seems like its not too common.

[APToddlerMama]

Originally Posted by by-the-lake 

Hi! Interesting you should ask this. I too had my son at 35 weeks, cause unknown. I asked my OB who specializes in high risk pregnancy if I was a canidate for P17
. He said that the studies showed only a slight increase of decreased preterm labor with P 17 verses oral Prometruim. I am currently taking oral Prometruim until week 35. Anyhow, his rational was that the slight increase of decreased preterm labor was not worth the pain and possible risk of infection with weekly intramuscular injections. Also, the FDA has just given a patent to a private company who has raised the price from about $20 per injection to like $ 1500. The drug was previously made by special formulary prior to this.
I am not sure how this fits into your situation with placental abruption. Did the abruption cause preterm labor? Was it an incidental find? How did your son do?

We didn't know about the abruption until after he was born actually.  I am guessing the abruption would have caused it then, but do you happen to know if PTL can cause the abruption?  I guess that would make a difference.  He did fairly well after his birth with a brief NICU stay, but does have some special needs which may or may not be from his birth.  Do you happen to know the name of the company that the FDA gave the patent to?

My main concern is that I was going through one manufacturer's research (their own I'm assuming) and was kind of shocked to find out that the risk of stillbirth was significantly higher in the group that was on the shots.  There was actually no statistical difference in neonatal death/stillbirth for the group on the shots versus off, because those off of it did tend to lose their babies due to preterm labor, and those on the shots carried their babies longer, but had much higher rates of stillbirth.  I just guess I don't understand why doctor's are prescribing this considering the other risk factors when the number of live births is essentially the same.  I feel like I'm missing something...

Dashley--Thank you too!  I can't figure out how to multiquote.  Anyhow, have you had any history of abruption?  How many mg/day were the suppositories?  Were you able to find any research on second/third trimester safety? 

[by-the-lake]

Here is some info on the P17 FDA patent

FDA approved a commercial form of the drug, called Makena, manufactured by K-V Pharmaceutical Co. of St. Louis. The company said Wednesday that the drug will be available for shipping March 14 and that it will cost $1,500 per dose.

Can you ask you doc if oral or vaginal progesterone can be prescribed? The thing my doc explained to me about any drug involving a fetus is unethical, and data gathered to make certain assertions of effacity are collected in all circumstances, meaning there is really no 'control group' in which to conduct this research.

I wonder in your instance, it may be impossible to determine if the preterm labor or abruption came first. I have more commonly seen where an abruption triggered preterm labor, because when an abruption occurs, the body goes into labor. I think this is the body's way to protect itself, because an abruption can cause maternal and fetal death, so the body kicks i to labor to 'get rid of the issue'. Make sense? The abruption may not be apparent until after delivery sometimes.

[dashley111]

The suppositories carry lower risk of complication than the injections- BUT the risk for ANY complications are very, very low for both.  The risk of a second of third preterm birth are much higher. 

I'm seen at a clinic specifically geared toward preventing preterm birth in people with previous preterm labor.  I wish I had some of the info in front of me that you can find in the clinic. 

I dont know what the specific dose of the suppositories are, I have yet to start them for this pregnancy- I am only 14 weeks now.  But I know they are something I have to have special made at a pharmacy because they are not just typically carried by pharmacies. 

I did not have an abruption, but did have a uterine hemorrhage.  I spent 6 weeks pregnant in the hospital on monitors before ultimately giving birth.  My son was born in pretty good health- only problems swallowing and needing to be tube fed.  He had the chance to receive steroid treatments before birth, though, and I think those made a huge difference in the outcome. 

[dashley111]

http://findarticles.com/p/articles/mi_m0CYD/is_14_40/ai_n27868791/

[APToddlerMama]

Originally Posted by by-the-lake 

Here is some info on the P17 FDA patent

FDA approved a commercial form of the drug, called Makena, manufactured by K-V Pharmaceutical Co. of St. Louis. The company said Wednesday that the drug will be available for shipping March 14 and that it will cost $1,500 per dose.

Can you ask you doc if oral or vaginal progesterone can be prescribed? The thing my doc explained to me about any drug involving a fetus is unethical, and data gathered to make certain assertions of effacity are collected in all circumstances, meaning there is really no 'control group' in which to conduct this research.

I wonder in your instance, it may be impossible to determine if the preterm labor or abruption came first. I have more commonly seen where an abruption triggered preterm labor, because when an abruption occurs, the body goes into labor. I think this is the body's way to protect itself, because an abruption can cause maternal and fetal death, so the body kicks i to labor to 'get rid of the issue'. Make sense? The abruption may not be apparent until after delivery sometimes.

I totally think you're right about the abruption triggering PTL.  That is my gut feeling but I guess I will never know for sure because there was no sign of placental abruption until examining the placenta.

After going back on the Makena website though, there is no way in hell I'm doing the shots.  Here is the link http://www.makena.com//media/PDFs/full-pi.pdf .  They actually did use a control group.  Here is what they say on their own website... There were 306 women in the study who received the shot and 156 who received a shot that was a placebo, so the control group.  You can go in and see the chart which is on the fourth page, but here it is in a nutshhell..

Makena Miscarriages <20 weeks gestation C 5 (2.4%) versus 0 miscarriages in the control group
Stillbirth 6 (2.0%) versus 2 in the control group (1.3%)
Antepartum stillbirth 5 (1.6%) versus  1 in the control group (0.6%)
Intrapartum stillbirth 1 (0.3%) versus 1 in the control group (0.6%)
Neonatal deaths 8 (2.6%) versus 9 in the control group (5.9%)
Total Deaths including miscarriages prior to 20 weeks 19 (6.2%)  versus 11 in control group (7.2%) 

They state themselves:  Due to the higher rate of miscarriages and stillbirths in the Makena arm, there was no overall survival difference demonstrated in this clinical trial. 

They also do show the stats where women definitely are delivering later in their pregnancies on the shots, so their claim that the shots prevent PTL are true and accurate, but I think it is a pretty big deal that there is actually no statistical difference in the total losses, and there are more stillbirths and miscarriages in the group taking the shot.  Those who were able to carry their babies longer didn't have any better outcomes.  They just prevented PTL but experienced the statistical same amount of loss. 

UGH.  These shots seemed like the magic trick.  I guess i will have to look into continuing the progesterone suppositories and see if they have the same risks or have even been studied like this.  Thanks everyone for your help! 

[APToddlerMama]

Originally Posted by dashley111 

The suppositories carry lower risk of complication than the injections- BUT the risk for ANY complications are very, very low for both.  The risk of a second of third preterm birth are much higher. 

I'm seen at a clinic specifically geared toward preventing preterm birth in people with previous preterm labor.  I wish I had some of the info in front of me that you can find in the clinic. 

I dont know what the specific dose of the suppositories are, I have yet to start them for this pregnancy- I am only 14 weeks now.  But I know they are something I have to have special made at a pharmacy because they are not just typically carried by pharmacies. 

I did not have an abruption, but did have a uterine hemorrhage.  I spent 6 weeks pregnant in the hospital on monitors before ultimately giving birth.  My son was born in pretty good health- only problems swallowing and needing to be tube fed.  He had the chance to receive steroid treatments before birth, though, and I think those made a huge difference in the outcome. 

I am glad things turned out okay with your son Dashley.  Is the hemorrhage related to the placenta or what happens? I hope this pregnancy is easier for both of us!
 

[dashley111]

Yes, my placenta was halfway lodged in my uterus- so I was not able to fully deliver it, and I bled from the spot that has detached.

I really suggest looking into the suppositories some more.  I saw the post on the Dec DDC also.  As far as i have been able to find there were no incredible risk factors for the suppositories, just the injections.

[nia82]

I had PTL with DS starting around 26-28 weeks, terbutaline from 32-36 weeks and he was born 37+2. When I got pregnant with DD I started out with an obgyn who said I need progesterone shots weekly from 16 weeks to 36 weeks. I did some research and didn't want it, especially as I felt my prior pregnancy wasn't that marked by PTL nor an early delivery. She also said it's part of a trial (Makena wasn't approved/came out until after DD was born). THat totally turned me off. I also know of three other women who were pressured to take the shots by that doctor (and only one has a true history of very early deliveries, and despite the shots her water broke at 31 weeks and her daughter was born 2 days later due to infection). So I felt that I personally would only opt for that stuff if I was facing a truly super early delivery... I didn't take any progesterone in this pregnancy but high levels of vitamin D3 instead (6.400IU daily) as I came across a couple studies linking low D to PTL. I spontaneously gave birth to DD at 39 weeks exactly. And there has been lots of PTL in my family (my mom had cerclages and tons of terbutaline with all of us, so did her sisters, one of my sister had monster doses of terbutaline too).

[APToddlerMama]

Originally Posted by dashley111 

Yes, my placenta was halfway lodged in my uterus- so I was not able to fully deliver it, and I bled from the spot that has detached.

I really suggest looking into the suppositories some more.  I saw the post on the Dec DDC also.  As far as i have been able to find there were no incredible risk factors for the suppositories, just the injections.

I'm definitely going to do that.  Do you know when your placenta detached?  Mine is detached partially already now at 13 weeks and has been for several weeks.  Thanks for your help!

[APToddlerMama]

Originally Posted by nia82 

I had PTL with DS starting around 26-28 weeks, terbutaline from 32-36 weeks and he was born 37+2. When I got pregnant with DD I started out with an obgyn who said I need progesterone shots weekly from 16 weeks to 36 weeks. I did some research and didn't want it, especially as I felt my prior pregnancy wasn't that marked by PTL nor an early delivery. She also said it's part of a trial (Makena wasn't approved/came out until after DD was born). THat totally turned me off. I also know of three other women who were pressured to take the shots by that doctor (and only one has a true history of very early deliveries, and despite the shots her water broke at 31 weeks and her daughter was born 2 days later due to infection). So I felt that I personally would only opt for that stuff if I was facing a truly super early delivery... I didn't take any progesterone in this pregnancy but high levels of vitamin D3 instead (6.400IU daily) as I came across a couple studies linking low D to PTL. I spontaneously gave birth to DD at 39 weeks exactly. And there has been lots of PTL in my family (my mom had cerclages and tons of terbutaline with all of us, so did her sisters, one of my sister had monster doses of terbutaline too).

Thank you for your input :).  I came across the same vitamin D info just recently on here and am thinking that is what I am going to do as well as Vitamin E which is supposed to help the placenta stay attached (which I think is what caused my first PTL).