Women with early, nonviable pregnancies of unknown location who were given an active management strategy had more successful pregnancy resolutions than those given an expectant management strategy, according to a recent clinical trial published in JAMA.
The findings provide essential data for fertility clinicians to better guide their patients with when making informed choices about their pregnancies, according to Emily Jungheim, MD, the Edmond Confino, MD, Professor of Obstetrics and Gynecology and a co-author of the study.
"When it comes to pregnancy and women’s health, we really are trying to get to a place where we can be more patient-centered, and I think this particular study is in that spirit. It provides us more information to help educate our patients with when they’re faced with these tough decisions of what makes the most sense for them," said Jungheim, who is also chief of Reproductive Endocrinology and Infertility in the Department of Obstetrics and Gynecology and a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.
The diagnosis of persistent pregnancy of unknown location is made when a woman's serial human chorionic gonadotropin hormone concentration levels are not increasing as normal, coupled with an ultrasound scan and estimating the date of conception.
However, an ultrasound may not demonstrate evidence of a pregnancy, resulting in a pregnancy of "unknown location." More so, a nonviable pregnancy can be life-threating if the pregnancy is deemed ectopic, when the fertilized eggs is implanted outside the uterus in the fallopian tube.
Depending on the patient's case and their personal goals, a clinician will recommend either an active management strategy — resolving the pregnancy with drugs or surgically removing abnormal tissue from the uterus — or an expectant management strategy, which involves actively observing the pregnancy and waiting for it to resolve naturally. The rates of success for either strategy in terms of resolving the pregnancy, have remained understudied.
For the current clinical trial, investigators enrolled 255 women at an average age of 31 years who were diagnosed with an early, nonviable pregnancy of unknown location at 12 U.S. medical centers. The women were then randomized to receive either expectant management or active management, which involved uterine evacuation surgery followed by drug treatment as needed.
Overall, women who received active management compared to those who received expectant management more frequently experienced a successful resolution of their pregnancy, with 51 percent versus 36 percent, respectively.
The study demonstrates a shift in reproductive medicine becoming more patient-centered, according to Jungheim, adding that the present data will be essential for healthcare providers to better educate and guide patients.
I think the bottom line is it’s just so personal. Especially in reproductive medicine, now we really try to take a patient-centered approach where you look at two options and say these are your options, these are the potential outcomes and at the end of the day, I will support you in either one of these."
Emily Jungheim, MD
This work was supported by the National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development.
Barnhart, K.T., et al. (2021) Effect of an Active vs Expectant Management Strategy on Successful Resolution of Pregnancy Among Patients With a Persisting Pregnancy of Unknown Location The ACT or NOT Randomized Clinical Trial. JAMA. doi.org/10.1001/jama.2021.10767.