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.