Friday, April 25, 2008

Failure To Give Option of Methotrexate in 1998 To Treat Ectopic Pregnancy Is Not Substandard Care -by Doc B.

Ectopic Pregnancy and Methotrexate Question & Answer With Dr. B.

Question by Rachel: In January of 1998, my friend was diagnosed with an ectopic pregnancy. Her doctor gave her two options, one laprascopic surgery to remove the tube with the ectopic or wait and follow up with multiple HCG’s and ultrasound. She chose the surgery and then was not able to get pregnant without invitro fertilization. In 2003, I heard that methotrexate could have been used to treat my ectopic. Did my friend's doctor commit malpractice when he failed to treat her with methotrexate?

Doc B: Remember, the standard of care used to judge a doctor is the standard of care in effect at the time of the treatment, in the example that you give, January of 1998. It is never appropriate to view a doctors actions in hindsight which is always 20/20. The simple answer to your question is that the standard of care did not require giving such a patient the option of methotrexate in 1998. The following should explain the basis of my opinion.

An ectopic pregnancy occurs when a fertilized ovum is implanted in any tissue other than the uterine wall. Most ectopic pregnancies occur in the Fallopian tube (tubal pregnancies), but implantation can also occur in the abdomen, cervix and ovaries. A fetus produces enzymes that allow it to implant in varied types of tissues, and thus an embryo implanted in a place other than the uterus can cause tissue damage and pain in its efforts to reach a blood supply.

In a normal pregnancy, a fertilized egg enters the uterus and settles into the uterine lining where it grows. About 1% of pregnancies are in an ectopic location ( a location other than the the womb.) More than 98% of ectopic pregnancies occur in the Fallopian tubes. This usually results in some bleeding. The bleeding usually expels the implantation out of the tubal end as a tubal abortion and no further treatment is often needed. (Many women who think that they had a miscarriage actually had a tubal abortion.) Inflammation of the tube with an ectopic pregnancy is not the cause of pain. Pain is caused by prostaglandins released at the implantation site, and by free blood in the peritoneal cavity. It is possible that bleeding can become heavy enough to threaten the health of the woman. However, if left untreated, over half of ectopic pregnancies will resolve without treatment. These are tubal abortions. Despite that fact, medical observation and/or treatment is always recommended.

Prior to 2000, the vast majority of ectopic pregnancies that needed treatment were corrected by either laparoscopic surgery or laparotomy (open surgery.) Treatment with methotrexate was not the standard of care in January of 1998 because it was not FDA approved nor was it recommended in the Physicians Desk Reference. The ACOG bulletin came out in December of 1998 for the first time recognizing it as a possible option. However, it still did not become the standard of care to offer this option until about 2000. After 2000, it became more common at research centers and large women’s hospitals to offer this option. In private practices, some doctors still do not recommend the option because the post medication pain can be severe and the required follow up very time intensive. Even today, methotrexate is not recommended for patients wanting to get pregnant any time soon, nor is it appropriate for patients who tend to be uncooperative because patient followup and reporting is essential. Furthermore, methotrexate remains only about 70% effective in treating ectopic pregnancy. That success rate is even lower in cases of repeat ectopic pregnancies.

Causes of Ectopic Pregnancy
Pelvic inflammatory disease, smoking, advanced maternal age and prior tubal damage are well known risk factors for ectopic pregnancy.Damage to the cilia or blockage of the Fallopian tubes is likely to lead to an ectopic pregnancy. Women with pelvic inflammatory disease (PID) have a high occurrence of ectopic pregnancy. Build-up of scar tissue in the Fallopian tubes causes damage to cilia. Surgery to remove damaged tubes remains a treatment of choice in most cases.

Older patients are at higher risk for ectopic pregnancy with advancing age. Also, smoking is associated with a higher ectopic risk. Women exposed to diethylstilbestrol (DES) in utero (aka "DES Daughters") also have an elevated risk of ectopic pregnancy.


Symptoms
Early symptoms of ectopic pregnancy may occur at a mean of 7.2 weeks after the last normal menstrual period. However, in the absence of an ultrasound demonstrating a heart beat in the Fallopian tube, ectopic pregnancies are rarely discovered until they are in the process of rupturing. Symptoms may include:
1. Pain in the lower abdomen, and inflammation.
2. Pain while urinating.
3. Vaginal bleeding.
4. Pain while having a bowel movement.

Patients with a late ectopic pregnancy typically experience pain and bleeding. This bleeding will be both vaginal and internal. External bleeding is due to falling progesterone levels. Internal bleeding is due to hemorrhage from the affected tube. The differential diagnosis at this point is between miscarriage, ectopic pregnancy, and early normal pregnancy. A positive pregnancy test typically rules out pelvic infection as the cause of the pain.(PID is often the first suspicion in diagnosing an ectopic pregnancy. ) With severe internal bleeding, the patient often has lower back, abdominal or pelvic pain. Other common symptoms include shoulder pain caused by free blood tracking up the abdominal cavity and severe cramping. Keep in mind the majority of ectopics are not definitively diagnosed until they rupture. When a patient gets these symptoms, it is incumbent upon her to immediately go to the emergency room.

HCGs
An abnormal rise in blood βhCG levels may indicate an ectopic pregnancy. The threshold of discrimination of intrauterine pregnancy today is around 1500 IU/ml of (βhCG). Today, a high resolution ultrasound may aid in a quicker diagnosis. An empty uterus with levels lower than 1500 IU/ml may be evidence of an ectopic pregnancy, but it is also consistent with an early intrauterine pregnancy or with fetal demise a (miscarriage.) If the diagnosis is uncertain, it may take several days with repeat blood work and ultrasound before a diagnosis is reached.. If the βhCG falls on repeat exam, this strongly suggests a miscarriage or possible rupture. The definitive confirmation of an ectopic comes with an ultrasound showing a gestational sac with a fetal heart beat in the fallopian tube. Free fluid which is non-echogenic is a normal finding in the late menstrual cycle and early normal pregnancy. This is a transudate and is not presumptive evidence of bleeding. Echogenic free fluid suggests the presence of blood clot and is suggestive of free blood in the peritoneum. A laparoscopic surgery or a laparotomy can often be used to visually confirm an ectopic pregnancy.

Surgical treatment

Surgical intervention may be necessary if there is evidence of ongoing blood loss. However, as already stated, about half of ectopic pregnancies result in tubal abortion and are self limiting. Laparoscopy or laparotomy can diagnosis and remove the ectopic or the entire Fallopian tube. Modern patients who use methotrexate, still sometimes need exploratory surgery because the medication does not work or because they are still in severe pain.

Chances of future pregnancy

Recurrent ectopic pregnancy is greater then 10% after the first ectopic. After a second ectopic it becomes three times more likely that another ectopic will occur. Most patients resort to invitro fertilisation to achieve a successful pregnancy. Use of invitro fertilization reduces the likelihood of further ectopic pregnancies and maximizes the chance of a healthy pregnancy.

Complications of ectopic

The most common complication is rupture resulting in internal bleeding. Death from rupture is rare in women who have access to medical facilities. Most ectopic pregnancies are definitively diagnosed at or about the time of rupture!

External resources

The Ectopic Pregnancy Trust- Information and support for those who have suffered the condition by a medically overseen and moderated, UK based charity, recognised by the National Health Service (UK) Department of Health (UK) and The Royal College of Obstetricians and Gynaecologists

Disclaimer: This article should not be used as a substitute for medical advise or treatment. As always, if you need medical treatment or advice, immediately consult your physician.

40 comments:

Anonymous said...

Very interesting topic. I like it when you give us some substantive law and/or science. I used methotrexate in 2004 for an ectopic. It was explained to me that Methotrexate was a cancer treatment but that it sometimes works for ectopics. For me, it did not work and I still needed surgery.

I know insurance companies like to save a buck, but I think I would have been much better off to have the surgery right away without trying methotrexate.

Anonymous said...

I know someone who got pregnant after previously treating with methotrexate and her child had a birth defect. I will always wonder about cause and effect in that case...

Anonymous said...

After reading this, I think I am ready for med school or law school or both! Thanks.

Anonymous said...

I would rather not take "off label drugs"

Ms Calabaza said...

I agree with anonymous 10:33.

Anonymous said...

I think "frying" your insides with a cancer drug to get rid of an ectopic is crazy. If it does not abort natually, get out the scope, doc.

Anonymous said...

Give me the scope and spare the drugs!

Legal Pub said...

One of the longer more scholarly articles. Thank you Dr. B. Readers this was the first in a two part series with Dr. B.

Anonymous said...

I had it. Did not kill me or anything. Could not have a baby naturally so they implanted me.

Got twins. I'm happy.

Anonymous said...

I had three ectopics. Methotrexate never worked on any of them. I had to have both tubes removed.

Anonymous said...

I used methotrexate in 2005 and had a good result. I think the Dr. told me at the time it was about 60% effective in aborting a tubal.

Anonymous said...

Dr. B. thanks!

Anonymous said...

All of the comments really helped. I think I will try methotrexate but I realize it does not work for everyone.

Anonymous said...

The problem with methotrexate is the doseage. Before 2000, they were just guessing and experimenting with doseage. They now have a better data. They are trying to use half doseages to reduce side effects. It still is not favored by over 50% of the OBGYN's for treatment of ectopic.

dollar bill said...

Family doctors generally do not have training for surgery. So in order for them to treat the patient they either prescribe drugs (methotrexate) or they have to refer the patient.

Insurance companies don't always have the patients best interest at heart and are just looking for the cheapest route. They fund a lot of pro methotrexate studies.

Dollar Bill

Anonymous said...

I used methotrexate. I still needed invitro to get pregnant.

I hurt like h@ll for 2 weeks after my methotrexate shot! When the pain finally went a way, I told my doctor that I wish I would have had my tube removed. Six months later I had another ectopic! Then I had to have surgery anyway.

Anonymous said...

It usually ends up costing an arm and a leg with methotrexate and then you still have pain for about 15 days. Sometimes the pain is worse then the ectopic pain!

Anonymous said...

A recent jury trial in Indiana concluded that Methotrexate is not an option that must be given to the patient. Now, it is ok to give the option if the doctor is familiar and comfortable with the treatment. However, the standard of care still does not require that the Dr. offer the option if he is not comfortable with its use.

Legal Pub said...

Legal Pub is all over that case!

Anonymous said...

Great explanation of a difficult topic.

Anonymous said...

Helpful comments. :)

Anonymous said...

I did ok with methotrexate.

Anonymous said...

Excessive bleeding may occur post methotrexate injection. You need to be monitored closely in follow ups!

Anonymous said...

I am currently on methotrexate, although i have had no side effects as yet 4 days on, which makes me think it isn't working. I would try anything first rather than losing a tube. If it doesn't work at least i gave it a go and tried to save my tube.
I certainly don't see it as "frying my insides" but more like desperate times desperate measures.

Anonymous said...

Good luck to the poster above. For many Methotrexate works. You just need real good followup monitoring with your doctor. Keep us posted.

Anonymous said...

Thanks (poster above) My levels are falling rapidly and i have an no bad side effects what so ever. I realise i have been lucky with this but it's still beyond me why so many posters say the wish they'd just had their tube out immediately. Each to their own i suppose.

Anonymous said...

Congrats above. I think the problem is some of us used methotrexate and then still needed surgery.

Also, when I had methotrexate, they did not tell me I would have a high risk for future ectopics. I did and ended up with tube removal. Mostly, it depends on your age and whether you want any more kids...

Anonymous said...

I agree. Whether to use methotrexate is a decision that you really need the input of your doctor on. Trust what he or she thinks best.

Anonymous said...

Methotrexate did get rid of my ectopic. But I hurt like h*ll for almost 2 weeks waiting for the shot to abort the ectopic!

Anonymous said...

Thanks for a great discussion of this option.

Jill

Anonymous said...

Methotrexate is a good way to treat rheumatoid arthritis.

Anonymous said...

Had a metho shot in Feb 09. My levels fell rapidly. Took about 3 weeks for the expulsion of zygote. No pain after shot as some posters expressed. I was lucky I guess. My tube was saved and I am now waiting my 3 months to try again.
Send me good thoughts for a successful future pregnancy.

Shirley said...

Good job girl. I had to weight 4 months, but I got pregant post methotrexate.


Shirley

Anonymous said...

:)

Anonymous said...

Ah, This is exactly what I was looking for! Dispells
some contradictions I've seen

Griffin said...

There really isn't much discussion about this online. I had Methotrexate almost 3 weeks ago, and 1 week ago had to go in for emergency surgery and ended up having my left tube removed. Unfortunately I was not properly informed by my doctor of the potential risks. I knew that Methotrexate had the possibility of not working, but I was assured this was extremely rare. I assumed it would not happen to me. Needless to say, it happens a lot. To some extent, I'm still glad I tried Methotrexate first, because without trying, I might have regretted opting for surgery later. It has drawn out the process a little more, but now that it's all over, I know I tried everything. Lesson learned: doctors sometimes minimize the risks so as not to scare you, but in reality they should be making sure that you know it CAN happen to you and to get your butt to the ER when you suspect something is wrong.

Legal Pub said...

Griffin: Very fair observation. For many it is worth trying even if it doesn't work. As more and more is discussed, it is possible to have an opportunity to make an informed decision. Best of luck.

Anonymous said...

i went to the dr a week and a half ago with a pain in my lower right stomach and found out i was pregnant (on birth control) when the dr told me he wanted me to go straight to the ER because he wasnt sure if it was my appendix or an ectopic......when in the ER they did an ultrasound and while i was waiting on the results from the ultrasound tech a dr came in to explain the two possible options -the methotrexate and surgery - but when the ultrasound tech came in and gave the results that is was an ectopic the surgeon came in and explained that she did not think that the shot was an option for me because the tube was already stretched out in danger of rupturing from what they could tell and with the pain i was having i would be in danger of bleeding internally from the rupture because the shot takes 5 days to even start working on aborting the baby from the tube........so when your dr suggests surgery you might want to listen cause they can see more than we can when they look at those ultrasounds and they can tell how much pain you are in when you go in......when i woke up after the surgery the surgeon told me that it was best because when they went in to take the ectopic out the ended up removing my right tube and a full cup of blood because my tube had ruptured from the time they did the ultrasound to the time of the surgery......I have 2 kids already that i am very thankful for but for those of you who may go through this my prayers are with you cause no matter how far along you are this is a very hard thing to go through because it is still your baby and there is no chance of saving it and it is possible to have to have a tube removed so ladies look at all options before you decide to go through with the shot because before you make urself go through the pain there is a chance to save your tube with the surgery as long as it has not ruptured before that time! Good luck to anyone who goes through this and my prayers are with you!

Anonymous said...

Great discussion and comments.

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