Is 17-Hydroxyprogesterone Caproate (17P) Safe for the Baby During Use in Preterm Birth Prevention?
Monday, January 14, 2008
Kenneth F. Trofatter, Jr., MD, PhD
•At Wed Jan 02, 10:11:00 AM 2008, Anonymous said…
Hello- I'm currently 15 weeks pregnant with my 3rd child. I have six year old twins that were born at 34 weeks (I originally went into PTL at 29 weeks). With a few rounds of Mag Sulfate and bedrest and drugs at home I was able to hold off until 34 weeks for delivery. My OB is suggesting Delalutin at 16 weeks in an effort to avoid the possibility of preterm labor with the pregnancy. I'm concerned because there are so many horror stories on the web about limb deformitites and stillborn babies from delalutin. Most seem to be from the 70's - has the product changed much since then? Wouldn't it make sense to assume my previous pre-term issues were related to a twin pregnancy?
Thanks
•At Wed Jan 09, 10:38:00 AM 2008, Anonymous said…
I too am in a similar situation. I gave birth to my son at 29 weeks due to a severe infection. My doctor also wants to put me on Delalutin injections starting at 17 weeks with my current pregnancy. I have researched this injection and found similar results to yours in terms of limb and genital defects as well as still births. I am extremely concerned and wondered in this medication has improved at all from the 70's as well. Any information would be greatly appreciated!
The use of 17P to help prevent early miscarriage and preterm birth dates back to the time before I started my residency in OB/GYN. In fact my first three children were 17P babies after my wife had had three consecutive miscarriages. Although there were no good controlled clinical trials, the teaching was that “It worked,” the side-effects for the mother were minimal (mostly injection site discomfort), and there did not appear to be the same level of risk for birth defects that was seen with DES. We went for a long period of time, however, when 17P was dropped from our regular armamentarium as we tried certain other drugs to help interrupt and delay preterm labor and birth. Unfortunately, none of these drugs have been very effective, almost all have unsatisfactory side-effects (and, in some situations, may be dangerous), and despite all efforts, the preterm birth rate has only continued to increase in the U.S. as we have addressed in this forum on previous occasions.
Although it is very difficult to predict who will have preterm labor and delivery, certain risk factors are associated with it and one of the most reliable is a prior history of preterm birth. Indeed, the earlier in gestation a prior preterm birth occurred, the greater the likelihood a woman will deliver prematurely again. And, if she has two or more preterm births, her risk can approach 50% that the next baby will be delivered early.
It was with cautious optimism then that we welcomed, a large, multicenter, randomized, double-blinded, placebo-controlled trial that showed weekly injections with 17P reduced by about one-third the risk of preterm delivery in women who had previously had a preterm birth (Meis, et al., N Engl J Med 2003;348:2379-85). That optimism grew when secondary analysis of the data revealed that 17P had its most beneficial effects on reduction of deliveries less than 34 weeks which incur the greatest risks for short- and long-term morbidity and mortality and excessive cost of medical care (Spong, et al., Am J Obstet Gynecol 2005;193:1127-31). In this later analysis, however, some concerns were also raised that there appeared to be a slightly higher fetal loss rate in the women who had received the 17P, but at this time, it cannot be concluded that this was the result of the drug itself or of other factors related to this high risk population of women. Early miscarriage rates and birth defects could not be commented upon in this study because the 17P was not begun until the patients were at least 16 weeks pregnant – well past the time of organogenesis and the usual time of miscarriage.
Anyway, returning to our readers’ comments, my first answer is no, the medication has not changed at all from the time it was introduced years ago. In fact, if anything, since the drug is now ‘formulated’ at compounding pharmacies across the nation, and is not under the scrutiny of BIG PHARMA (the product is no longer made by a pharmaceutical company – just wasn’t worth holding onto over the years), it’s composition is even less rigorously controlled, although the formulation is probably too simple to mess up in any way that would deleteriously affect either its safety or efficacy.
With regard to the issue of birth defects, especially the concerns related to limb and genital defects, let me first state that should probably not be a major worry at this point. As stated above, the currently recommended use of the drug involves starting it well beyond the development of the baby’s arms, legs, heart, genitalia, etc. All of that is basically completed by 12 weeks, and most even earlier. It is true that continued growth of all organs proceeds throughout the pregnancy and neurologic development, in particular, well beyond first trimester is especially important to the baby’s outcome, but to date, no data would suggest a major problem related to this. Of course, it will take many years to sort out whether or not subtle effects on the brain and neurologic or behavioral abnormalities are associated with the use of 17P.
To support these points, let me cite a few references. In 1982, Varma and Morsman evaluated the use of hydroxyprogesterone hexanoate (very similar to 17P) in early pregnancy for its adverse effects on fetal development (Int J Gynaecol Obstet 1982;20:13-17). One hundred and fifty women were begun on this drug by intramuscular injection at 6-8 weeks gestation and continued on therapy until 16-18 weeks. The control group consisted of 150 women with similar problems, primarily, recurrent miscarriages, who received no hormonal therapy. No significant differences related to adverse fetal/neonatal outcome or development were noted between the two groups.
The teratogenic effects of 17P have been evaluated in several animal studies. Seegmiller and colleagues (Teratology 1983;28:201-8) treated mice with doses of 17P ranging between 10 and 200 times the human therapeutic dose. At the highest doses (100 and 200 times the human doses), they found higher risks of maternal deaths (8% and 13%, respectively); and, all doses resulted in a slight increase in embryonic resorption (4-12% above controls). However, in surviving animals and their offspring, there were no significant affects on intrauterine growth, sex ratio, or malformation rates and it was specifically noted that the drug did not increase rate of masculinization, nor did it alter the development of nonreproductive organs.
In a later study, also done in mice, doses of 17P equivalent to 0.7, 7.0, and 70.0 times the dose in humans were administered between gestational days 7 through 19 – roughly equivalent to the period of most significant embryologic development in humans (Carbone and Brent, Am J Obstet Gynecol 1993;169:1292-8). In this study, no differences in fetal weight, resorptions, fetal deaths, number of male fetuses, or malformations were noted between the treated and untreated animals. Again, because of anecdotal concerns raised many years earlier, they specifically noted that there were no no increases in genital or nongenital birth defects, and no increase in limb deformities or bone calcification in the group treated with the 17P.
Hendrickx and colleagues (Teratology 1987;35:129-36) studied the effects of 17P given alone or with an estrogen (estradiol valerate) in rhesus and cynomolgous monkeys at weekly intervals between 20 and 140 days gestation. Although a higher rate of embryologic deaths were noted in the Rhesus monkeys (but not in the cynomolgous monkeys) at doses equivalent to (1X) and 10 times the human dose, no significant malformations or developmental abnormalities were identified. Not to belabor the work done to date in animal models, I would simply refer you to a recent review article on the subject by Christian and colleagues (J Matern Fetal Neonatal Med 2007;20:89-112). In this comprehensive review, the authors conclude that 3 studies point to a higher risk of embryo-fetal toxicity, including the ones cited above, but no consistent or significant teratogenic effect has been confirmed with the use of 17P.
Bringing this home, perhaps more reassuring is another recent study (Northen, et al., Obstet Gynecol 2007;110:865-72) that did follow-up evaluations of the babies born in the original 2003 17P trial of Meis and colleagues. At a mean age of follow-up in 194 children exposed to 17P and 84 placebo controls, “no significant differences were seen in health status or physical examination , including genital anomalies” between the 17P and the placebo children. Testing scores for “gender-specific roles” were also normal and comparable between the two groups. Since this is the only randomized, controlled study of substance published to date, it must be considered the most reliable information available as well and it would appear that 17P, as used in this trial, beginning at 16-18 weeks gestation, has a minimal risk for the fetus and newborn, at least from the standpoints of birth defects and development.
So, the final question...would I use 17P on my own kids again? Yeah, they all did turn out a little on the strange side, but look at who's their Daddy!
Labels: 17-hydroxyprogesterone caproate, 17P, delalutin., preterm delivery
62 Comments:
At Tue Jan 15, 04:58:00 PM 2008,
--c. said…
hi dr t --
i wrote in earlier after delivering my second stillborn daughter -- both after pprom. (to refresh your memory, my name is carole, i have a slightly elevated titer of anticardiolipin, and also typically take prometrium in my first trimester due to low measurements & three 1st trimester miscarragies.) i am now pregnant again (about 5 1/2 weeks) and have been prescribed a version of your empiric treatment: 4 mg folic, prenatal, heparin & baby aspirin, plus extra vitamins e & c, plus the daily prometrium. i am also going to see a perinatologist starting week 12 for biweekly cervical scans, although in both pprom events i had neither an infection nor, as far as anybody could tell, an incompetent cervix. (i have carried one baby to term with a normal labor that ended in a c-section.)
i am going to be put on 17P starting in my second trimester. my two docs agree that preterm labor has not been my problem, but they are also of the opinion(s) that the 17P can't hurt the pregnancy. would you consider this a normal or reasonable approach?
At Tue Jan 15, 06:46:00 PM 2008,
Anonymous said…
Thank you Dr.Trofatter for your informative response regarding P17 risks and preterm labor! I had mentioned in my original question that I went into labor at 29 weeks due to a Group B Strep infection. In your response you had stated that you weren't sure that I was a canidate for P17. Is this due to the circumstance of infection? Also, am I prone to infection due to having a previous one? Thank you in advance for your help as it is difficult to find information regarding this topic.
Sincerely,
Kerri
At Wed Jan 16, 06:57:00 PM 2008,
Kenneth F. Trofatter, Jr., MD, PhD said…
To Carole: Hello again! I like the idea about going to see the MFM folks. It will be interesting to see what your cervix does over time. I doubt the 17P will "hurt" but a lot depends on the cause of the PPROM. See why I am sometimes converned under these circumstnaces in my response to the reader right after you. Good luck with your pregnancy and please let me know how things turn out! Dr T
At Wed Jan 16, 07:04:00 PM 2008,
Kenneth F. Trofatter, Jr., MD, PhD said…
To Anonymous Jan 15: Yes, ny concern is the possibility of the 117P 'hiding' an infection. I don't thinnk it necessarily places you at greater risk for getting an infection, but it could suppress your body's response so that the infection gets further along then in normally would before we realize you have it. If you have read any of my posts on GBS, it can be a sneaky bug! Many women are chronic carriers of GBS and some seem to have a suboptimal immune response to it and are, therefore, at risk for recurrent complications related to the bacterium. Many women with PPROM or with an 'unexplained' fetal demise may have had 'subclinical' infections that damaged the baby without causing overt evidence of an infection in the Mom. That's why I would be a little hesitant to prescribe it to you, but that's just my personal opinion! Thanks again for reading. Dr T
At Thu Jan 17, 07:13:00 AM 2008,
--c. said…
THANK YOU for the heads up about the infection. a subclinical infection would make so much sense. my ob this time is going to do bv cultures regularly, but i'll ask about 17P and other infections and be on the lookout for that, as well.
it's so hard not to have an answer for recurrent pprom, but it is very relieving to know there are things we can look for that we didn't look for before. thank you!
At Thu Jan 17, 11:47:00 AM 2008,
Kenneth F. Trofatter, Jr., MD, PhD said…
To -c Jan 17: You're welcome and GOOD LUCK! Dr T
At Thu Jan 17, 06:54:00 PM 2008,
Anonymous said…
Hi I was hoping you could give me some insight. I am 34 y/o soon to be 35 and have two healthy boys, 7 and 5. I would like to have another baby. I had two miscarriages last year, one at 10 weeks and another at 6 weeks. I am pregnant for the third time and have an HCG of 20 at 5 weeks and the doctor wants me to wait a week and have the HCG test repeated. she checked my progesterone levels (on the second pregnancy they were very low, but they said it looked okay this time) I have been off birth control for a year and can tell that my endometriosis is coming back because of increased cramping, I have HTN, and have been experiencing what they think may be PMDS. What is my next step if I do lose this third pregnancy in a row. I feel lost, upset, and wonder if there is something else that could be wrong...Please help!
JM
At Mon Jan 21, 04:44:00 PM 2008,
Kenneth F. Trofatter, Jr., MD, PhD said…
To Anonymous Jan 17: I do not have a simple answer for you. That hCG is VERY low for a 5 week pregnancy, so that is not a good sign at this point. he REI docs with whom I work believe that endometriosis is a significant cause of recurrent early pregnancy loss for reasons we do not fully understand. If you have endometriosis, they would probably suggest Lupron suppression for 6 months and then ovulation induction with Letrazole and hCG. Also if you are hypertensive at your age, I would recommend a weight reduction program (if you are overweight) and give some thought to metformin therapy for several months prior to conception as well. What sort of workup have you had to date from the immunologic, thrombophilia, and hormonal standpoints? I am curious to know. Thanks for reading and please get back to me! Dr T
At Wed Jan 23, 07:05:00 PM 2008,
Anonymous said…
Dear Dr. T,
Thank you for your response. I have gotten better news since I wrote you on 1/17/08. My HCG increased from 20 to 1360 in one week. My doctor ordered another HCG that I had taken today and my levels are now over 3000. I am scheduled for an ultrasound in the morning because I have been cramping when I am on my feet alot or with exertion. There is no spotting, but she is trying to role out a tubal because of my history. The only work up that I have had is for my thytoid and progesterone. According to the charts my thyroid is wnl,but there is a family history of problems. With my second miscarriage my progesterone was low. When she tested me this time around 1/14/08 she said my levels looked ok, but they did not tell me what they were (that was when my HCG was 20). I know that they were not very optomistic at that time. I had another test taken today and have to wait 2-3 days for the results. I should be 6 weeks according to my last menstrual cycle on 12/13/07. I am 5'5 and weigh 140 pounds. I have had HTN since I was 32. I think I forgot to mention that every pap test comes back that I have inflammation. My endometriosis was diagnosed before I had my first child. I am not familiar with the treatments or tests that you mentioned, but am willing to do research. I really appreciate your advice and direction. I am hoping that all is going to be ok this time... I guess I will know more tomorrow, but truth be told I am still nervous. Is there anything else I should be asking my doctor for? I have never had problems conceiving only progressing with the last two pregnancies.
Thanks again and I look forward to reading your next post.
At Thu Jan 24, 04:38:00 PM 2008,
Anonymous said…
Dear Dr. T,
Anonymous Jan 17 again. Update, they saw a gestational sac, but said too early to see baby. Progesterone levels dropped from 23 to 17 despite increasing HCG. Should I be worried?
Thanks for your help
At Fri Jan 25, 08:05:00 AM 2008,
Kenneth F. Trofatter, Jr., MD, PhD said…
To Anonymous Jan 23: Great on the hCGs. You probably just ovulated later than you thought. No other sugestions for the time being. At your current hCG level, they should be able to tell you if this preganncy is in the uterus by ultrasound. Hope things go well for you this time, and if they don't we can talk about those other things! Regards, Dr T
At Fri Jan 25, 11:23:00 AM 2008,
Kenneth F. Trofatter, Jr., MD, PhD said…
To Anonymous Jan 24: I am encouraged by the hCG rise, but discouraged by the progesterone fall. I hope it is not real, but if it is and you do lose this pregnancy,you might benefut from progesterone support (not 17P) staring in he luteal pahsea after ovulation and continuing through first trimester. Best wishes and luck! Dr T
At Mon Jan 28, 06:45:00 PM 2008,
Anonymous said…
Dear Dr. T,
Thank you so much for your response. It is helpful to get your opinion and advice. My doctor started me on progesterone suppositories 2 times daily after the decrease from 23 to 17 and my cramps decreased. I started them on 1/24/08, but began some spotting yesterday and today. I was devestated and called my doctor. She ordered another US for 2/1/08 with repeat HCG and Progesterone levels. I am guardedly hopeful. I will keep you posted. thank you!
At Wed Jan 30, 07:09:00 AM 2008,
Kenneth F. Trofatter, Jr., MD, PhD said…
To Anonymous Jan 26: Thanks for letting me know. We will be pulling for you...
Dr T
At Tue Feb 05, 07:13:00 PM 2008,
Anonymous said…
Dear Dr. T,
update from anonymous Jan 26. US shows heart beat, HCG over 33,000, and progesterone 20. We are keeping our fingers crossed.
Thanks for your site, your input, and support.
At Wed Feb 06, 05:18:00 PM 2008,
Kenneth F. Trofatter, Jr., MD, PhD said…
To anonymous Feb 5: Great news! hang in there, girl! Let us know, okay? Dr T
At Thu Feb 07, 02:36:00 PM 2008,
Anonymous said…
Dear Dr. Troffater.
i have previously been pregnant 3 times and have delivered prematurely with all of them, 17 wks, 22 1/2 wks, and 7 1/2 wks. i am currently pregnant for the fourth time, 16 wks. this sat. my doctors suggest that i have weekly injections of 17 Hydroxy progesterone to prevent preterm labor of this pregnancy. however they are uncertain as to whether the cause is preterm labor or incompetent cervix. i was told that this drug is only beneficial for the prevention of preterm labor. i am very skeptical when it comes to relying on drugs of any sort, and am not sure as whether i should go through with this treatment or not, only to regret it later. i have researched this and have not found enough info. assuring me of it's safety. i am currently on bed rest. can strict bed rest keep me from delivering prematurely again, or will i need to have the injections administered? are there any alternatives to this?
At Thu Feb 07, 02:51:00 PM 2008,
Anonymous said…
Dear Dr. T-
in your opinion, which is more beneficial, a cerclage or 17 Hydroxy progesterone injections? i was recently told that after administration, if the injections do not work, i may need the cerclage. what factors make me a candidate of either of these and determine their effectiveness? what are the risks/ side effects, long term/ short term?
At Fri Feb 08, 05:46:00 PM 2008,
Anonymous said…
Dear Dr. Trofatter:
If I take 17Hp for one pregnancy, would I be required to take it for all future pregnancies, or will I be given the option?
At Thu Feb 14, 06:58:00 PM 2008,
Kenneth F. Trofatter, Jr., MD, PhD said…
To Anonymous Feb 7: Your questions are straightforward and excellent and the answer is not so simple. At some point I will have to devote another whole post to cerclage. The answer depends on what your doctors think they might be treating and quite frankly, that depends, somehwat, on a detailed review of the previous pregnancy complications that you have not told me about and that have led you to this point. If you truly have an 'incompetent cervix', personally, I am a cerclage person. Placed early in pregnancy (13-14 weeks), a cerclage carries very low risks and is highly effective if the person who has placed it really does it right. Unfortunately, many cerclages are NOT well-placed and their efficacy has come into question more for this reason than anything else. Your doctors probably have not been able to determine (based presumably on your past OB history) whether you had problems related to premature labor or whether you have an incompetent cervix. (It can be extremely difficult once the cervix has begun to change to decide which came first, the cervical change or the contractions). Under those circumstances, we will often follow you with cervical ultrasounds, consider using 17P if the history is strong enough, and then place a 'rescue cerclage' if and when the cervix starts to shorten (particularly if here is "funneling" of the membranes into the cervical canal), although this might not happen until 18-22 weeks (and sometimes even later). Of course, placing a cerclage at this point always carries more risk than if placed earlier in the pregnancy, but again, in experienced hands, it is often successful in prolonging pregnancy, especially if very early preterm birth appears imminent if something isn't done. The 17P appears to be relatively safe from midtrimester on, but I would suggest you read the blogs I have already posted on this subject. I wish you luck! Please let us know how things turn out.
At Thu Feb 14, 07:24:00 PM 2008,
Kenneth F. Trofatter, Jr., MD, PhD said…
To Anonymous Feb 7: Personally, with your history, I would have placed the cerclage at 13-14 weeks, still followed your cervix with serial ultrasound examinations, starting at about 16 weeks, and considered the 17P if you had any evidence of uterine activity. We have done a study with a vaginal progesterone compound (Prochieve) that seemed to be most effective in preventing early delivery in women with a short cervix. Since this is the same progesterone that your body and the placenta make, it should be completely safe for the baby. I do NOT trust bedrest alone for various reasons. And I certainly do not trust progesterone alone for a true incompetent cervix! Good luck and let us know how things turn out. Dr T
At Thu Feb 14, 07:29:00 PM 2008,
Kenneth F. Trofatter, Jr., MD, PhD said…
To anonymous Feb 8: If the 17P has a beneficial effect in your case, that will not carry over to another pregnancy. It has no long-term benefits. If you take it for one pregnancy, didn't really need it, and did well, you'll probably do well the next time whether or not you take it! The question is, do you want to take the chance of not taking it if you really do benefit it! Wish the answers were simple, but they are not! Thanks for reading! Dr T
At Fri Feb 15, 11:38:00 AM 2008,
Anonymous said…
hi dr t -- it's carole again. i realize as i keep reading the comments and your answers that i don't know how or why 17P works. do we know? i'd love to know if it's (relatively) easy to explain.
At Sat Feb 16, 12:46:00 AM 2008,
Anonymous said…
Dear Dr. T:
Anonymous Feb. 07 again- Thank you for your informative response! To fill you in on my history, my first pregnancy, I went into labor at 17 wks.. I began having strong contractions at work, but did not realize what was happening at the time. There was no bleeding. Later that evening, I delivered the amniotic sac, still attached and full of fluid, but without the baby, who was still inside my uterus. The heartbeat began dropping rapidly, resulting in the death of my baby. My labor was induced by the doctor popping the sac. This is when I first found out that I was O-. My husband is O+. My second pregnancy, I went to the ER at 20 wks., due to vaginal bleeding after an uncomfortable, restless night. That's when they told me I was dilated 4cm with ruptured, bulging membranes. Since I have always had strong cramping during my menstrual cycles, I again, thought nothing of it. My uterus appeared to be tremoring instead of contracting. I was in the hospital for two weeks, before I delivered my baby who only lived for an hour. My third pregnancy, I miscarried at 7 1/2 wks.. Each time I was working, and on my feet constantly. I often wondered if the weight of the baby played a part in this.
That brings me to this current pregnancy. This past Tuesday I had an ultrasound done to check my cervical length. The result was a 4.6, which my doctor says is good. He said that anything below 3 is to be concerned about. He then ruled the cause out to preterm labor and not incompetent cervix. I decided to go ahead and take the 17Hp, which will be given weekly. Hopefully this will be beneficial for this pregnancy. I am trusting the Lord to bring me to full term this time! Once again, thank you for your response. I will be sure to keep you posted!
Sincerely,
Ana
At Fri Feb 22, 08:10:00 AM 2008,
Anonymous said…
Hi Doctor T-
I posted my original question to you on Jan. 15th regarding 17P injections. I told my doctor my (and your)concerns about it possibly hiding an infection and he agreed to do routine screening for Group B Strep. My question is do you feel this will be an effective preventative measure? Also, I am 23 weeks along and was "diagnosed" with a short cervix (2.93mm)does this automatically put me at a higher risk for preterm labor and if and when would you recommend a cerclage in my situation?? My doctor has put me on modified bed rest as well. Thanks for your input!! Kerri
At Fri Feb 22, 08:40:00 AM 2008,
Anonymous said…
Hi again! I just wanted to add to my last posting that I also have PCOS. I asked my doctor if there was any relation to my son being born at 29 weeks with this disorder and he assured me that they were unrelated. However, I just read one of your postings regarding a correlation between an incompetent cervix and PCOS. This was something that I had suspected from the beginning after meeting several mothers with PCOS in the NICU. Do you feel that my previous preterm labor could be a result of PCOS and will P17 help in my situation? Also, do the hormone changes associated with PCOS have anything to do with preterm labor? Thanks again, Kerri
At Fri May 09, 03:25:00 PM 2008,
Megan said…
I was told about the injections from a friend who had them in her last pregnancy. I have a short cervix, but what has not appeared to be IC. With my first healthy pregnancy (2 prior miscarriages in the first trimester) my cervix shortened from 35mm to 22mm between 19 and 28 weeks. It stayed around 22-23mm from 28 weeks on and I delivered just about at term. With my second pregnancy I was never checked due to insurance flaws, but stayed off my feet when I could and delivered my son almost at term by repeat c-section. I am currently 17w4d pregnant with my 3rd healthy pregnancy and just had a scan that showed my cervix to be at 26.8mm but firm and closed. I am going to be rechecked in 11 days from now, and was wondering if I should ask about the injections or if there is anything else I should be doing, or not doing. I have stopped all exercising and am doing as little as possible with a 2 and a 1 year old at home. Also, since I have had short cervix before (at least in 1 pregnancy) but never had PTL could I just have a shorter but still firm cervix? Thank you for any and all advice you can give.
Megan
At Tue May 20, 03:29:00 PM 2008,
Mom of 3 boys said…
I am 11 weeks pregnant with my 4th child and my Dr talked to me about putting me on these 17P shots because my last child ( he is now 2) was born at 36wks by c-section because I was in lbor. He said that I would start them at 16weeks and continue through 36 weeks. Is it something I should do and what side effects are there? My first child was born at 41wks after some preterm labor and bedrest, second was born at 39wks scheduled c-section and my third was born at 36weeks and weighed 7lbs and was completely healthy. Do you think that it is really nessacary to hve these shots?
At Sun May 25, 04:31:00 PM 2008,
Kenneth F. Trofatter, Jr., MD, PhD said…
Mom of 3 boys said:
I am 11 weeks pregnant with my 4th child and my Dr talked to me about putting me on these 17P shots because my last child ( he is now 2) was born at 36wks by c-section because I was in lbor. He said that I would start them at 16weeks and continue through 36 weeks. Is it something I should do and what side effects are there? My first child was born at 41wks after some preterm labor and bedrest, second was born at 39wks scheduled c-section and my third was born at 36weeks and weighed 7lbs and was completely healthy. Do you think that it is really nessacary to hve these shots?
At Sun May 25, 04:34:00 PM 2008,
Kenneth F. Trofatter, Jr., MD, PhD said…
To Mom of 3 BOYS: I am not going to try to second guess your doctor here, but you have minimal risk for very preterm delivery and, therefore, it is unlikely the 17P will be much benefit, unless you have a history of premature cervical "shortening" early in each of your pregnancies. One option would be to have you doctor evaluate your cervical length periodically and then consider the 17P if it should start to shorten. Good luck and thanks for reading! Please let us know how things turn out. Dr T
At Wed Jun 25, 07:31:00 AM 2008,
Anonymous said…
Hi Dr. T. I had an early miscarriage of my first pregnancy at 10w2d. I'm now pregnant at nearly 6 wks with my second and I questioned my doctor about progesterone support. He said that while it wasn't proven to benefit any in cases such as mine, it wouldn't hurt me if it didn't help. I agreed to take it for my peace of mind but now I'm questioning its safety for such a use. What is your opinion?
At Thu Jun 26, 06:41:00 PM 2008,
Kenneth F. Trofatter, Jr., MD, PhD said…
To anonymous June 25: Your doctor is probably using a natural progesterone compund (just like your ovaries and the placenta make) and that should be perfectly safe at this time. Dr T
At Fri Jun 27, 07:22:00 AM 2008,
Anonymous said…
June 25 Anoy, here-Actually he prescribed 17-P. I have the shots in my posession but after doing some extensive reading I'm just not comfortable with what I'm coming across. As foolish as I may feel for telling him this, I feel that the risks outweigh any possible benefits and I'd rather go natural right now and see how things go. He did NOT recommend this therapy, I asked him for it and to be quite honest may have pressured him into it. My rading shows 17-P has been proven to be somewhat useful in preventing preterm labor but not recurrent m/c unless there is a documented progesterone deficiency and that is not the case here. If I suffer another miscarriage, I'll go see a specialist to get further testing to determine the cause but right now for all I know it could have been an isolated incident. Does any of this make sense?
At Sat Jun 28, 06:15:00 PM 2008,
Kenneth F. Trofatter, Jr., MD, PhD said…
To Anonymous June 25: I all honesty, many years ago, we routinely used 17-P for women with recurrent early pregnancy loss. In fact my 26 and 24 year old sons were 17-P babies after my wife had had 3 miscarriages. It is probably safe enough, although I have my own questions, and that's why I would prefer a natural progesterone. I think your plan is very sensible and for your own comfort, probably the best thing to do.
At Fri Jul 04, 12:55:00 PM 2008,
Joyful Mama said…
Dr. T--
I am blessed with 7 healthy children despite having an incompetent cervix and having to have a cerclage each time. I struggle each time with PTL, using a lot of terbutaline to get these guys to term. The terbutaline seems to bother me more as I get older (raises blood sugar, lungs feel full, heart racing). Now I'm pregnant again and reading about 17-P. Am I a good candidate for this? Any likelihood that it would reduce my need for the terb? Thanks!
At Fri Jul 11, 07:39:00 PM 2008,
cmgrzadz said…
Hi Dr. T~
I was wondering if you could offer any insight into whether or not bedrest would be needed or should be highly considered? My first son was born at 24 wks, just went into labor went into traige was dilated to 4cm and they tried to hold off the contractions that I wasn't aware I was having. They also said that I had an infection when they tested the placenta after delivery. My 2nd pregnancy, I was on 17P started at 18wks, had a rescue cerclage (2 stitches)placed at 16 wks (which I did feel some contracting)and was placed on strict bedrest while I had weekly measurements or my cervix and contraction activity (I had a few trips to triage because of shown shortening and contractions being seen). I delivered a healthy son at 36 wks the night the cerclage was removed. I am now 17.5 wks, had a prophylactic cerclage placed at 13 wks - they found my uterus is prolaspsed, it took three attempts and only one stitch this time. I will start 17P next week. My concerns is that I feel contractions now, I am still working currently but won't be at the latest July 28th, have a 3.5 yr old boy, and I feel lots of pressure on my cervix when the contractions and cramping starts. I didn't know if the prolapsed uterus would cause more of the pain in the cervical area or not and if I should really consider strict bedrest. The last pregnancy I was put on strict bedrest just because of my history and not sure if it was incompetent cervix or PTL or both. I swear by the 17P and the cerclage, but I am really hesitant on the strict bedrest as I now have osteitis pubis possibly from the bedrest before, my pregnancies and playing soccer. Any thoughts? Sorry for such a long post! Thanks for your time!
At Sat Jul 12, 07:53:00 PM 2008,
Kenneth F. Trofatter, Jr., MD, PhD said…
To joyful mama: It is certanly worth a try! You also might ask your doctors to consider using nifedipine (procardia) rather than terbutaline. It is probably much safer in your case and will not cause your blood sugar to rise. Dr T
At Mon Jul 14, 03:34:00 PM 2008,
Joyful Mama said…
Thanks, Dr. T! I just spoke with my doctor about both the 17P and the Procardia. We're going to consult with a perinatalogist, but we're leaning toward both. I appreciate this article and your response!
At Mon Jul 14, 06:52:00 PM 2008,
Kenneth F. Trofatter, Jr., MD, PhD said…
Good luck joyful Mama. Let us know how things turn out! Dr T
At Mon Jul 14, 07:25:00 PM 2008,
Kenneth F. Trofatter, Jr., MD, PhD said…
To cmgrzadz: I don't think I would recommend complete bedrest at this time. However, your doctors might consider fitting you for an oversized pessary to help support the uterus and the cervix. (They can explain what that is to you - it's like a big, irregularly shaped rubber doughnut). That will help to prevent prolapse and add support at the level of the internal cervical os (if it is fitted well) to help keep some pressure off the cerclage as well! Once it is fitted, just leave it in place and remove it once or twice a week to clean it. Good luck to you and let us know how things turn out! Dr T
At Thu Aug 14, 05:04:00 PM 2008,
Anonymous said…
Hello Dr. T,
I am 16 weeks pregnant with my second child, and my doctor wants me to begin the progesterone injections next week.
I had PTL with my first pregnancy beginning at 32 weeks. We were able to control the contractions with bedrest, tocolytics, and fluids. I also received two doses of Betamethasone. At 36 weeks (and 4cm), my water broke, and I delivered my healthy (just small) baby a few hours later. In your opinion, am I a strong canidiate for the therapy? I am apprehensive about undergoing a treatment if it is not absolutely necessary. Thank you for your help.
At Sat Aug 16, 07:50:00 PM 2008,
Kenneth F. Trofatter, Jr., MD, PhD said…
To anonymous Aug 14: You meet the criteria for someone who MIGHT benefit from 17-P. I will often follow cervical lengths in women with your history between 18 and 24 weeks to see if cervical incompetence might have contributed to your previous problems. Good luck! Dr T
At Wed Sep 10, 11:07:00 AM 2008,
Anonymous said…
I am not sure I am in the right section of your blog, but I will post my question here. What about the use of Terbutaline to stop pre-term labor? Last weekend I went into the hospital after 4 hours of painful contractions every 4 minutes (I was 29 weeks). I was given an IV and 5 shots of Terbutaline during the night. There was no cervical change. Do you think this was truely pre-term labor (I thought the true definition involved a cervical change)? I should mention that I have a bicornuate uterus, but carried my first baby to 41 weeks. I have been reading about Terbuatline since I got home, and am now worried about the side effects. Are there any safer options, in the event this happens again?
At Wed Sep 10, 05:32:00 PM 2008,
Kenneth F. Trofatter, Jr., MD, PhD said…
To anonymous sept 10; the best thing you have going for you is that you carried that other pregnancy to term. Did you have any evidence of a urinary tract infection or was that not checked? Personally, I am not a big fan of terbutaline. I still use magnesium sulfate as an initial therapy if a patient really appeasr to be in preterm labor and then follow-up with nifedipine (procardia), a calcim channel blocking drug. Before 30 weeks, I may couple that with indomethacin, but if you read about that, it may scare you even more! Good luck with things! Dr T
At Wed Sep 17, 03:07:00 PM 2008,
Anonymous said…
Hi. I am eagerly reading any info on 17P as my OB has rec'd I begin injections. My daughter was born at 33 weeks gestation (and required significant med. assistance even at 33 wks). I experienced a miscarriage before her pregnancy and another last year, after the successful pregnancy. I am highly concerned about 17P despite having read the Meis article, Northern article RE no teratogenic effects, etc. I have read my chances of another preterm baby are ~16-20%. On the flip side, I work with children with special needs and am unsure which risk is greater. Could you please share your insight? Many thanks! MM
At Tue Sep 23, 07:30:00 PM 2008,
Kenneth F. Trofatter, Jr., MD, PhD said…
To MM: The final answer regarding the safety of 17P will probably not be known for many years. It must be relatively 'safe'. Regardless, I would like to know more about the circumstances surrounding your early delivery. was this preterm labor, premature rupture of membranes or a necessary delivery secondary to preeeclampsia or some other problem. I gather it was preterm labor if your doctors want to use 17P. However, they might also want to do some serial ultarsound exams in midtrim,ester to see if you might have an incompetent cervix as well. Just a thought! Best of luck and let me know how things turn out! Dr T
At Thu Oct 02, 01:54:00 PM 2008,
Anonymous said…
Dr. Trotter: Thanks for your reply--I realized I had not left sufficient info! My first miscarriage prior to my daughter's birth was at 8wks with no heartbeat at u/s. Second (after my daughter's birth)was at 10weeks with heartbeat at u/s but subsequent bleeding and m/c. Progesterone levels in early pregnancy always high. Both u/s after demise suggested loss around 7 weeks. Fetal tissue testing after 2nd m/c reported trisomy 16 (expected) with no other anomalies. No genetic testing on myself (CA 35) or my husband (age 46). My daughter's birth was 2 to SROM. No other warnings. No cervical incompetence or other. Just water-broke, baby here in 5 hours situation! It has been suggested I was having contractions without knowing. I have now completed 16 1/2 weeks and will return for big u/s in 2 weeks at which time we'll finalize decision RE 17P. Any further info is greatly appreciated. Thank you kindly for your time. Mary-Margaret
At Wed Oct 08, 05:52:00 PM 2008,
Kenneth F. Trofatter, Jr., MD, PhD said…
To MM Oct 2: Ask your doctors to evaluate your cervical length at the next ultrasound and then perhaps serially at some interval thereafter. We have found that progesterone seems to have its greates benefit in women with a "short cervix" and if you have that, you are at increased risk fot preterm delivery in view of your past history. Indeed, you might even be a candidate for a cervical cerclage at that point. Best wishes and let us know how things turn out! Dr T
At Fri Nov 21, 11:59:00 PM 2008,
Anonymous said…
Dear Dr T.,
I have never been pregnant but have been put on Proluton Depot 250mg (which i understand is the same as hydroxyprogesterone caproate)every 5 days for luteal support after IVF. We have a case of unexplained infertility and that IVF attempt failed. I have read that proluton depot is actually luteolitic and an abortificaent in very early pregnancy (Pioneers in in Vitro Fertilization,by A. Th Alberda, Raoul Arif Gan, Hendicus Maria Vemer). Is there any other research to support this claim? Would the use of this medicine be under any circumstances justified for luteal support? Thank you.
At Mon Nov 24, 06:45:00 PM 2008,
Anonymous said…
Hi Dr. T -
My wife and I are currently debating whether or not to proceed with the course of 17P injections. I have found your posts on the subject to be very direct - which I appreciate. Our first child was born just under 37 weeks and our second child was born at 34 weeks. We are now in the middle of our third pregnancy and our new OB has prescribed the 17P course. I was wondering what questions you would recommend that we ask our OB to ensure that this is a prudent decision.
At Fri Nov 28, 10:48:00 AM 2008,
Kenneth F. Trofatter, Jr., MD, PhD said…
To anonymous Nov 21: I am afraid I do not know the answer to your questions. That is not something I have experience with in very early pregnancy. You should probably put your doctors on the 'hot seat' for that one! Best wishes, sorry I can't be more help at this time, and please let us know how things turn out. I learn new things by our readers' experiences too! Dr T
At Fri Nov 28, 10:51:00 AM 2008,
Kenneth F. Trofatter, Jr., MD, PhD said…
To anonymous Nov 24: Were your wife's pregnancies complicated by preterm labor? Did she premature rupture of membranes and then need to be delivered? Did she require treatment for preterm contractions before she actually delivered and if so, how early in the pregnancy was that necessary? 17-P is relatively safe, but in your wife's case, I would probably couple that with serial cervical assessment by ultrasound to see if she has any evidence of cervical insufficiency (incompetence) that may have led to her early deliveries. Best wishes. Dr T
At Mon Dec 01, 09:06:00 AM 2008,
Anonymous said…
Thank you for your response Dr. T - for reference this is Anonymous from November 24. In both cases, my wife experienced preterm labor without premature rupture of membranes (both children were breach and delivered via C-section). No treatment for preterm labor was done with our first. For our second pregnancy my wife began preterm labor around week 33 and she was put on bedrest. She also was given the steroid shots during this time for lung development. Her labor progressed and they attempted to delay labor with medication without success and she was delivered at 34 weeks.
At Tue Dec 09, 10:10:00 AM 2008,
S.Rodgers said…
First I have to say that I love your BLOG. I just had my first shot of 17P but am still not convinced that I really should be taking it. I was pregnant one time prior to this pregnancy but my cervix began shortening at around 28 weeks so I was put on some bedrest. I was rechecked at 30 weeks at which time I was put into the hospital with mag.sulfate. I delivered my daughter at 34 weeks. She was only 4 lbs, 14 oz. but is healthy now. My question is: 1) Would you recommend I go on 17P? I am 17 weeks and my doctor just started me on them yesterday but I am still very hesitant to continue. If I take the 17P until 36 weeks, do people usually deliver at that time? Does your body get used to it and then once you stop at 36 wks do you go into labor or is there no correlation? If my body did not need 17P but I went ahead and took it, would stopping the injections at 36 wks cause me to go into labor? Should I be taking the 17P this early? Can't I wait until 20+ wks to start the injections? Please help. I don't know what to do!
_LA School teacher
At Fri Feb 20, 02:09:00 PM 2009,
Anonymous said…
Dear Dr. T,
My name is Linda. My Perinatologist has prescribed 17P injection starting 17 weeks until 36 weeks. I had 2 misscarriages at 12 weeks and 8 week before my first daughter was borned at 34 weeks. The first daughter was born with birth defect and this defect is 96% perterm labor rate. I was bed rested and bleeding 5 weeks before emergency C-section. I was diagnosed placentia previa.
I didn't have complication with my second daughter and I was not on any medication. I was scheduled a repeat C-section at 38 weeks. She is a healthy baby. I'm scare to get 17P treatments. I want to ask your opinion whether if I am the right candidate to get 17P. Is it important to start early? Is there benenfits to use it longer vs shorter length? Thank you.
At Wed May 20, 12:29:00 PM 2009,
Anonymous said…
I am currently 16 weeks with my second pregnancy. During my first pregnancy, I went into preterm labor at 26 weeks. Unknown to me, I was contracting every 3 min - 5min. This was picked up during a routine visit when my son's heart rate was varying from 140's to 70's due to PACs. I was admitted to L&D,placed on a monitor and given terbutaline and steroid injections. My FFN was negative and cervical length was long. I was released after 1 week of bedrest. My water broke at 35 weeks and I was sectioned after failure to progress and some fetal decels. My son spent 2 days in the NICU for respiratory distress that never amounted to anything. My OB suggested 17P but is not overly aggressive in recommending it in my situation. What are your thoughts?
At Fri Sep 04, 09:20:00 AM 2009,
Vitale said…
Dear Dr. T.
Thank you for this great post on 17P. I am pregnant and have a very large subserosal fibroid (larger than 16 cm diameter). I'm at 24 weeks now, but it's been a difficult pregnancy. I've had episodes of severe pain due to degeneration and have recently started having frequent and regular contractions. My cervix looks fine; as of this morning it was long and closed. I've been taking procardia, which has helped with the contractions, but my doctor wants to also put me on 17P for the remainder of the pregnancy. He thinks that because of the uterine activity and the fibroid, I'm at risk for pre-term labor, and that the 17P might help. I know it is normally only recommended for women who have had pre-term labor before so I'm not sure what to do. On the other hand I'm also afraid of having the baby too early, which as I understand, from my Dr. and your post, carries greater risks than taking 17P. I wonder what your opinion would be on that question. Thank you very much.
At Fri Sep 11, 01:16:00 PM 2009,
MM said…
Hello-I am "MM" who posted anon. on Sept 17 2008. Just wanted to post a follow-up that I did begin 17p, but not until 20 wks, 6 days gestation (in line with the original study) and my son was born at 36 wks, 1 day (first child came at 33 wks, 4 days). I do want to mention that my son was born with hypospadias and chordee and has recently developed a perirectal abscess secondary to a fistula. Despite the majority of the literature supporting 17p as being innocuous (including Northern et al Obstetrics and Gyn 2007;110-865-872), I will always wonder if the 17p had any effect on my son's urogenital system... Thank you for your former advice; he was otherwise healthy and did not require any medical intervention during his natural delivery and is otherwise healthy!
At Sun Oct 18, 08:14:00 AM 2009,
Anonymous said…
While you were broaching the subject of progesterone injections I wanted to share my experience with you. I am a female of 35 years and I have a friend whi is a male of 37 years. Both our mothers were given progesterone injections in the 70s. I don't know in what dose or the title of the injection at the time but needless to say that I was found to have a double cavity uterue which stopped me having children until I received an operation to rectify it. My friend has a derormed penis which cannot be changed and I wonder if it could have been caused by these injectins that our mothers took. I dobn't want to scare anyone as i'm sure the chances of it happening are very small but I have read studies that say it can cause this sort of thing but it seems that it has not been researched an awful lot. So just please think carefully before taking any drugs in pregnancy.
At Fri Oct 23, 03:40:00 PM 2009,
Anonymous said…
Hello Dr. T,
My Dr. has suggested 17p for me and I have not yet decided if this is something that I am going to do. I had 2 healthy boys (one born between 36-37 weeks, and the other born at 35 weeks. They were both perfectly healthy and they came home with me 24 hrs. later. Then, unexpectedly, this past January, my 3rd baby was stillborn at 22 and 1/2 weeks. Tests were ran 24 hours before I lost the baby (because I thought I was in labor. However, my cervix was completely tight and closed). They took blood/urine tests. Everything was normal. They sent me home concluding that I was not in labor. Then, 24 hours later, I lost the baby. They never found out why. My O.B. at the time told me that he felt that this was an isolated incident and not related to my other 2 pregnancies. He told me that he felt I had a great chance of carrying a healty 4th pregnancy (If I desired). I now have a new O.B. This is now my 4th pregnancy. Would you reccomend that I receive 17p based on my history?
At Tue Jan 19, 08:41:00 AM 2010,
Anonymous said…
Hi Dr. T- I am pregnant with my second baby and am currently 23 1/2weeks. I had my first baby at 35 weeks. My water broke and I had a c/s bc she was breeched. My doctor suggested me taking the 17 hydroxyprogesterone shots due to having her preterm at 35 weeks. I was very skeptical when he first recommended this at 18 weeks. I just saw him yesterday to do a cervix check and everything looked great. I brought up the shots again and he said he would still start them regardless that I am already 23 weeks. I am so frightened of the side effects this will have on my baby. With my history would you recommend them and would it benefit me starting them this late into my pregnancy. Thank you so much.
At Wed Jan 20, 06:38:00 PM 2010,
Kenneth F. Trofatter, Jr., MD, PhD said…
To anonymous Jan 19: Since you are so leery of the 17-P shots, an alternative would be to have your doctor evaluate the cervix by transvaginal ultrasound. If the cervix is greater than 25mm in length and there is no funneling of the membranes past the internal cervical os into the canal, you are probably at low risk for very early delivery. If the cervix is short or has funneling, I would give serious thought to taking the 17-P shots. Best wishes.
Dr T
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