HSE review underway after woman claims ectopic pregnancy was misdiagnosed

Catherine Shanahan speaks to a woman who received treatment to end what she was told was a non-viable pregnancy but who later found out that the diagnosis was incorrect.

ON January 6, 2013, at approximately 6am, Laura Esmonde woke with a scream.

“I had a really sharp pain in my left leg. When I turned on the light, it was twice the size of my right leg,” she says. “I rang the local GP co-op service, and, because of my medical history, I was told go straight to the emergency department at South Tipperary General Hospital.”

The then 35-year-old’s medical history included a bilateral pulmonary embolisum (PE), or blood clots in both lungs, two weeks after she gave birth to her second child, Jesse. At Caredoc’s behest, she travelled from her home on Old Monastery Rd, on the outskirts of Tipperary town, to the local emergency department (ED).

According to her medical notes, she was admitted to the ED with a swollen left leg, “purple in colour”, and with acute lower back pain “which radiated down her left leg”.

She was admitted to hospital following a diagnosis of deep vein thrombosis (DVT), a blood clot in a vein deep in the leg.

While tests were being carried out, a staff member asked a routine question prior to administering pain relief — could Laura be pregnant?

“When I thought about it, I said I could be, my period was late,” Laura says. A urine sample was requested and later that evening she was told that she’d had a positive pregnancy test.

Laura says she was initially nervous when she heard the news. While the arrival of her first child Amy, now 17, had been a straightforward natural delivery, the birth of Jesse, and its aftermath had been traumatic. She’d been very sick with the clots in her lungs. Still, it was 13 years on and the prospect of a new addition to the family was exciting. She reckoned she was about five weeks pregnant. She shared the good news with her sister. “I was delighted,” she says.

However, the delight was shortlived. The next day, she underwent a couple of ultrasound scans — of her leg and her pelvis. Scan reports record “extensive thrombus” (blood clot) in her left leg. In relation to her pelvis, the report says “No intra-uterine gestational sac seen” and “appearances suspicious of ectopic pregnancy”.

An ectopic pregnancy is a pregnancy outside the womb that is life-threatening to the mother.

“I didn’t have long to celebrate,” Laura says.

In light of this finding, a repeat ultrasound scan was carried out in the Early Pregnancy Assessment Unit the following day, January 8. Laura’s clinical notes for this scan again say: “Suggestive of ectopic pregnancy.”

The description of the findings of the transvaginal ultrasound are recorded as “thickened endometrium, no sac seen, right tubo ovarian mass with gestational sac and no fetal parts seen. Impression: ectopic pregnancy.”

There are ongoing references to a diagnosis of ectopic pregnancy in Laura’s medical notes. Because of the risk of rupture and internal haemorrhage the condition poses, it had to be treated. A number of treatment options exist. They include expectant management, a “wait and see” approach when the pregnancy fails to develop beyond the very early stages and the pregnancy tissue gradually dissolves and is reabsorbed into the body; medical treatment (using a drug called Methotrexate to end the pregnancy) or surgery.

In Laura’s case medical treatment was considered most appropriate. She did not undergo a diagnostic laparoscopy — a surgical procedure involving a camera to view the contents of the pelvis — prior to receiving the Methotrexate.

Laura was counselled before receiving the Methotrexate, a powerful drug used to treat a number of conditions including rheumatoid arthritis, certain types of cancer, autoimmune diseases, ectopic pregnancy, and for the induction of medical abortions. A log of her treatment, seen by the Irish Examiner, says Laura was “agreeable to same”. She was injected with a dose of Methotrexate on the evening of January 8. It was, she says, an emotionally stressful experience.

“I felt it was a double whammy, what with the deep vein thrombosis and the ectopic pregnancy,” she says. “I was very upset. I cried because a diagnosis of ectopic pregnancy meant there could be no happy outcome.”

Methotrexate stops the growth of rapidly dividing cells, such as embryonic, foetal, and early placenta cells.

A woman given Methotrexate to end an ectopic pregnancy has her pregnancy hormone levels tested several times in the following days and weeks. A drop in levels suggests that the pregnancy is ending (although it can rise initially following treatment and then drop). If pregnancy hormone levels are not dropping to the level expected, a second dose of Methotrexate can be required.

Laura didn’t feel great after receiving the drug but that was “more of an emotional thing”, she says. She remained in hospital for a further four days for treatment of the DVT, before being discharged on January 12 with an appointment to return to the Early Pregnancy Assessment Unit on January 15 for a check of her pregnancy hormone levels. She returned as scheduled. A repeat test showed her pregnancy hormone levels remained high.

Laura was subsequently telephoned and was asked to return again on January 17 for another hormone test. When she returned, a decision was made to re-admit her to the gynaecological ward for a second dose of Methotrexate as her pregnancy hormone levels remained high.

“When I came in that day, I didn’t have an overnight bag with me or anything,” she says. “I was told I would have to meet the consultant obstetrician. I hung around most of the day. Then I was told they were admitting me because my blood hormones hadn’t reacted they way they should have [after the first dose].”

Laura was upset about being readmitted. It was explained to her that her pregnancy hormone levels had reduced but not as much as expected. She was given a second dose of the drug on January 18 without being re-scanned. Over the next few days, her pregnancy hormones levels reduced, albeit very slowly.

In the meantime, the problem with Laura’s leg had still not resolved. Despite compression stockings and warfarin, it remained swollen. A doppler scan on January 19 showed little change compared to the scan of January 7. She was kept in hospital.

On January 24, Laura’s case was referred to vascular radiologists in Cork University Hospital for an opinion and two days later, she was transferred to CUH “for management of her DVT which was unresolving”.

“My leg was massively swollen, but I was fine otherwise,” she says.

Laura’s patient profile notes for CUH, dated January 26, record that she was diagnosed with DVT and an ectopic pregnancy at STGH.

Similarly, a nursing assessment carried out in STGH prior to her transfer on the same date records “ectopic pregnancy. Right tube.”

On the day she arrived at CUH, Laura was referred to the foetal assessment clinic at Cork University Maternity Hospital where she underwent a transvaginal ultrasound scan.

The report compiled on foot of this scan notes that she had been treated for an ectopic pregnancy. However, its findings appear at odds with an ectopic diagnosis. It records that “Appearance are now more c/w IUGS” — “consistent with intrauterine gestational sac”. In other words, the CUMH scan appeared to show that Laura’s pregnancy had been in the womb (intrauterine) rather than ectopic or “extrauterine” — outside the womb.

The scan notes also record the impression that the pregnancy was now “non viable” and that it was “not clinically currently suspicious for symptomatic ectopic” — in other words, that it was not, at the time of scan, showing symptoms of an ectopic pregnancy.

Two days later, medical notes of January 28 at CUMH again refer to “visible intrauterine sac on u/s” (ultrasound) and “non viable pregnancy”.

On January 29, following another ultrasound, medical notes refer to “non viable intrauterine sac and fetal pole but no fh” (foetal heartbeat). A fetal pole is the term used for the earliest signs of a baby in an early pregnancy ultrasound. In other words, the notes record that there was a gestational sac in the uterus, and there was early signs of a baby, but no heartbeat. A note accompanying these recorded findings refers to a “long discussion with the patient”.

Laura contends that this discussion had been on foot of being told at CUMH that she had an intrauterine pregnancy.

If this was the case, then she should not have been given Methotrexate, she says.

Laura was shocked.

She remained in hospital until January 31. Following discharge, she spent a lot of time mulling over what had happened. It took a while to recover from the DVT and to deal with the loss of her baby. On March 30, she decided to telephone STGH and make a complaint.

A log compiled by STGH of the sequence of events in Laura’s case records receiving the phone call from Laura “stating that she was told in Cork after transfer there that she did not have ‘an ectopic pregnancy but a uterine one’ and following the Methotrexate treatment, she miscarried her pregnancy”.

The log recording Laura’s claim is part of a confidential preliminary internal review of her case, instigated after she made the complaint. The review states that Laura, in her phone call of March 30, “asked for Methotrexate use to cease in the hospital as it had terminated her pregnancy” and requested her case be reviewed by the general manager.

The Health Service Executive review of Laura’s case concludes that an ectopic pregnancy was diagnosed by three separate ultrasound scans performed by three separate staff. It states that the medical treatment for the ectopic pregnancy (use of Methotrexate) was chosen due to Laura’s underlying condition of DVT.

It says the ectopic pregnancy was confirmed using a best practice clinical guideline drawn up by the Institute of Obstetrics and Gynaecology for the Ultrasound Diagnosis of Early Pregnancy Miscarriage.

The review says that, “in the absence of national/local policies or guidelines on the medical management of tubal pregnancy”, the clinical care was provided in line with the current Royal College of Gynaecologists guidelines.

One care management problem identified by the review was that Laura was not given any written information about the possible need for further treatment and adverse effects following Methotrextate as recommended by the Royal College of Gynaecologists guidelines. In fact, the review notes that there are “no guidelines in Ireland regarding Methotrexate use in the treatment of ectopic pregnancy”.

Laura was unhappy with the internal review. She believes that she was misdiagnosed and that her medical notes prove this. However, the review confines itself to her treatment at STGH, so there is no analysis of differing diagnoses. Her case is now the subject of an external review, requested by Laura last October.

The Irish Examiner asked the HSE if there was any discussion/follow up between CUMH and STGH in relation to the differing diagnoses, and received the following response: “As part of the HSE’s Serious Incident protocol, an external review of Ms Esmonde’s care in STGH in 2013 is underway. Staff in South Tipperary General Hospital are co-operating fully with this review as are clinicians in Cork University Maternity Hospital who are sharing any information required.

“Ms Esmonde is involved in this review process and will be presented with the findings, once finalised.

“It is not possible to comment further as this review process is not yet complete.”

The findings of a National Misdiagnosis of Miscarriage Review carried out in Ireland in 2010/2011 give Laura no cause for comfort. The review was instigated after a number of women publicly claimed to have been wrongly told their pregnancies were not viable following ultrasound testing, yet they went on to have a live birth.

Of 24 cases investigated, the review found 22 women went on to give birth. In five cases, women had live births after taking medications to induce miscarriage. However, for Laura, there would be no live birth.