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Misdiagnosis of ectopic pregnancy and administration of methotrexate when pregnancy subsequently found to be intrauterine (02HDC10862)

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(02HDC10862, 23 June 2004)

Obstetrician ~ Fertility centre ~ Ectopic pregnancy ~ Standard of care ~ Information about condition ~ Rights 4(1), 6(1)(a), 6(1)(b)

A woman underwent in-vitro fertilisation after she and her husband had experienced difficulties trying to conceive their first child for two and a half years; two fertilised eggs were placed in the woman's uterus. The fertility clinic staff carried out a series of hormone assays via blood tests to assess the viability of the pregnancy over the following three weeks, plotting the results on a logarithmic graph. Initially the hormone levels rose more slowly than normal and the woman was informed that the pregnancy was unlikely to be viable. A further test showed a noticeable rise in the hormone level, and the woman was suffering some pelvic discomfort; four days later, the hormone level had again risen considerably.

A transvaginal ultrasound scan, performed at the fertility clinic by the obstetrician, noted that the uterus was empty. Because of this, and the abnormal slow early rise in the hormone levels and evidence of a speck of vaginal bleeding, the obstetrician diagnosed a probable ectopic pregnancy (a pregnancy outside the uterus). She discussed management options with the couple: continued hormonal monitoring while waiting for the ectopic pregnancy tissue to die and be reabsorbed (expectant management), treatment with methotrexate, which destroys fast-growing cells, and surgical treatment with laparoscopy; the possibility of a normal intrauterine pregnancy was not discussed. Included in the discussion was the risk of the fallopian tube rupturing if the expectant management option were taken, and the side effects and possible failure of methotrexate treatment; the obstetrician did not discuss the effect of methotrexate on a viable pregnancy because she did not consider this to be the case.

The woman was admitted to a public hospital later that day. Further blood tests were taken, methotrexate was administered, and she was discharged home; follow-up blood tests were arranged. The first of these showed a further marked rise in hormone levels indicating a continuing pregnancy; two days later she had abdominal pain, backache and nausea and returned to the hospital, where a second ultrasound scan revealed a single live fetus, though smaller than expected, in the uterus. Because there was a significant risk of fetal malformation in this unusual situation, the pregnancy was terminated. The couple made a complaint that the diagnosis of ectopic pregnancy and advice to terminate was incorrect, and that the woman was not given sufficient time to reflect on her decision to take the methotrexate option, or sufficient information about the risks posed to a potentially viable fetus.

It was held that the obstetrician breached Right 4(1) in relying too heavily on the ultrasound findings in reaching her diagnosis, and deviating from standard practice in not arranging repeat checks before administering methotrexate.

She further breached Right 6(1) by not providing sufficient information about the limitations of the diagnosis on a single ultrasound scan. Having, albeit incorrectly, diagnosed ectopic pregnancy, her discussion of the available options and potential risks was satisfactory, although it was recommended that she needed to give the couple sufficient time to reflect on the decision. The public hospital was held to have acted in accordance with the protocol in place at the time, and was appropriately guided by the obstetrician's diagnosis and decision to administer methotrexate.

Following the event, both the obstetrician and the hospital apologised to the couple for the incorrect diagnosis, and reviewed their practices accordingly. Updated polices were put in place at the hospital to minimise the risk of a similar occurrence in the future, and to provide appropriate pregnancy loss counselling. The fertility clinic also improved its procedures in relation to early pregnancy care.