More effective active management for pregnancy of unknown location

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Among patients with persistent pregnancy of unknown location, active management using either uterine evacuation or empiric methotrexate was more effective in resolving pregnancy than expectant management, according to a randomized clinical trial.

More women randomized to active management methods for pregnancy of unknown location – which is a risk factor for ectopic pregnancy – successfully resolved their pregnancy compared to those randomized to expectant management (51.5% vs. 36%, respectively), reported Kurt Barnhart, MD, of the University of Pennsylvania in Philadelphia, and colleagues.

As the team’s study shows in JAMA, patients randomized to active management were also less likely to have unplanned surgery (12.7% vs. 26.7%) or receive unscheduled methotrexate (15.5% vs. 46.5%) .

Of all the patients who underwent active management to resolve their pregnancy, those who received a two-dose regimen of methotrexate did not fare worse than those who had uterine evacuation followed by medication. if necessary (54.9% vs. 48.3%, respectively).

“Pregnancy in an unfamiliar place can be, and often is, a serious event,” Barnhart said. MedPage today. These findings, he said, go against the perception that close monitoring of these patients is always the best way to treat them. It is also the first trial to compare the effectiveness of empiric methotrexate to uterine evacuation, he said.

The study had a fairly high crossover rate, with 39% of participants rejecting their randomized assignment to choose another treatment, Barnhart noted. Among those who chose a different treatment, a greater number of patients switched to expectant management compared to the uterine evacuation and empiric methotrexate groups.

“We now have objective data on how these three therapies work,” Barnhart said. “What we don’t know yet is what these patients want,” he said, adding that the results will help patients and providers make informed and shared decisions.

Amy Harrington, MD, of the University of Rochester Medical Center in New York, who was not involved in this research, said the study provides evidence-based information on the effectiveness of surgical and medical management persistent pregnancies of unknown location in relation to the management of pregnant women. .

“We usually give women all of these options, but we didn’t have good data on what would work best,” Harrington said. MedPage today. She said the results show greater predictability with active management methods, which means the plan will most likely work and progress to completion. But they also show that expectant management is a reasonable option for patients who choose it, she added.

“This study doesn’t necessarily change what we’re going to offer patients,” Harrington said. “But for the advice to patients, this is going to be really valuable.”

Although the diagnosis of early pregnancy failure is straightforward when an ultrasound definitively detects an intrauterine or ectopic pregnancy, imaging does not identify the location in about 40% of women who present for an ectopic or intrauterine pregnancy. evaluation, explained Barnhart and colleagues. Currently, there is no consensus around the optimal management of patients with prolonged pregnancy of unknown location.

For the study, Barnhart’s group set out to determine whether active or expectant management was more effective in resolving these pregnancies, and compared active management to a two-dose regimen of methotrexate with uterine evacuation.

The researchers reported the results of the ACT or NOT trial, a multicenter, randomized clinical trial to evaluate treatments for women with persistent pregnancy of unknown location. Participants included hemodynamically stable women over 18 years of age who had no evidence of definitive intrauterine or ectopic pregnancy detected with transvaginal ultrasound and pregnancy hormone levels consistent with non-viable gestation.

Expectant management consisted of close clinical monitoring and monitoring of human chorionic gonadotropin (hCG) levels serially every 4-7 days. In the surgical management group, patients underwent uterine evacuation followed by methotrexate for those whose hCG levels did not decrease by at least 15% after the procedure. In the medical management group, patients received a two-dose regimen of methotrexate, with two intramuscular doses of 50 mg / m2 given 3 days apart.

A total of 255 women were included in the study, evaluated between 2014 and 2019. Patients in the three treatment cohorts had an average age of around 32 years, and more than a third of each group used reproductive technology. assisted.

Almost 100 patients changed their allocation of randomization. About 48% of randomized patients refused uterine evacuation, 42% refused empiric methotrexate, and 27% refused expectant management. More patients who have chosen to switch treatment have chosen to receive expectant management rather than surgical and medical methods.

Overall, patients who underwent active management were more likely to resolve their pregnancies without changing their initial management strategy compared to those in the expectant management group (RR 1.43, CI at 95% 1.04-1.96). There was no statistically significant difference in both the time to resolution and the total number of visits between the active and pregnant groups.

Between the two active treatment groups, the two-dose methotrexate regimen was non-inferior to uterine evacuation. The time to resolution and the total number of visits were also not different between these two cohorts.

Across the three cohorts, 44.2% to 52.9% of women experienced vaginal bleeding, which was the most common adverse event.

Limitations of the study, the researchers said, included the high crossover rate, which may have introduced bias into the randomized clinical trial; and that a high percentage of trial participants had an early gestational age, low levels of pregnancy hormones, and were using assisted reproduction methods, which may have skewed the results.

  • Amanda D’Ambrosio is a reporter on the MedPage Today Business and Investigative Team. She covers obstetrics and gynecology and other clinical news, and writes articles on the US healthcare system. To follow

Disclosures

The study was funded by grants from NIH and the National Eunice Kennedy Shriver Institute for Child Health and Human Development.

Barnhart reported financial relationships with Swiss Precision Diagnostics and Bayer; the co-authors reported multiple financial relationships with the industry.

Harrington did not note any disclosures related to his comments.



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