Bleeding and cramping in early pregnancy can be normal but can also signal a nonviable pregnancy, including a potentially life-threatening ectopic pregnancy, which data suggest are on the rise.
Women experiencing these symptoms in the first few weeks after a missed period may seek answers at an emergency room or urgent care clinic. They often leave without clear answers, often leading to a diagnosis of “pregnancy of unknown location” along with instructions to return every other day or even daily for blood tests.
“It can be an incredibly anxious time for patients, particularly those with a history of miscarriage, ectopic pregnancy or infertility requiring IVF,” explains Nancy Fang, MD, MS, assistant professor of OB-GYN and Complex Family Planning at the CU Anschutz School of Medicine.
The monitoring via bloodwork is critical to identifying potentially dangerous complications, including ectopic pregnancy. Because of this, researchers aim to give women a more convenient way to monitor early pregnancy.
“Ectopic pregnancy remains a significant cause of death and complications worldwide,” said Cara Clure, MD, MSCS, assistant professor of OB-GYN and Complex Family Planning. She explained that in about 2% of pregnancies, a fertilized egg implants outside the uterus, typically in a fallopian tube, where it can cause the tube to rupture and lead to life-threatening internal bleeding.
Fang and Clure recently worked with CU Anschutz Innovations to test whether women diagnosed with pregnancy of unknown location could use Mira’s at-home urine-based hormone monitoring technology to monitor levels of the pregnancy hormone human chorionic gonadotropin (hCG). Early results of a pilot study are promising, and Fang believes the technology is safe and could “disrupt” the management of suspected ectopic pregnancy.
“This technology could change the way we manage pregnancy of unknown location and allow us to intervene and treat women at a much earlier point in time,” said Fang.
U.S. deaths from ectopic pregnancy are rising. A ProPublica analysis of Centers for Disease Control and Prevention data found 200 deaths from 2020 to 2025, double the 100 deaths reported in the previous six years.
Pregnancy of unknown location is a temporary diagnosis women may receive in early pregnancy when there’s a positive blood or urine test, but an ultrasound scan shows no visible sign of a pregnancy inside or outside the uterus. It’s why monitoring hCG levels via blood tests is so important during this time.
“It may simply be too early to see the pregnancy on an ultrasound, so we look at whether hCG levels are increasing at a rate consistent with a normal pregnancy or whether they’re rising abnormally or decreasing, which could indicate an ectopic pregnancy or miscarriage,” Clure said.
It can be a stressful time for patients. “The ability to monitor hCG levels at home and not have to find transportation or take time away from work can make this stressful time more accessible,” Clure said.
How CU Anschutz Innovations helps researchers collaborate with industry
“When people hear about CU Innovations, they often think about patentable discoveries. But we’re also here to help researchers navigate opportunities to collaborate with industry, build partnerships that can advance their work and translate innovative ideas into real-world impact,” said Doreen Molk, senior licensing manager at CU Innovations.
The pilot study included 31 participants – five nonpregnant women serving as controls and 26 women diagnosed with pregnancy of unknown location. They compared hCG hormone levels measured through traditional blood draws with those measured using Mira’s at-home urine-testing device, while also collecting data on patient experience, device performance and pregnancy outcomes.
The control group helped Fang and Clure confirm the device could accurately detect negative results. Early findings showed promise: The hCG levels in both the urine and blood tests were similar, suggesting the technology could offer a reliable alternative for monitoring early pregnancy.
“It’s very promising that this technology will do what we set out for it to do,” Fang said.
Ilya Kuznetsov is Mira’s head of business development and partnerships. He’s encouraged by the validation of their product, which was originally designed for women to monitor their fertility window, predict and confirm ovulation. It’s now being used to track hormone changes in perimenopause, PMOS and irregular cycles and broader hormonal health.
“What we’re seeing is that there’s a good basis for doing a follow-up study to include more participants," he said.
Studies haven shown that up to 1in 5 patients were not able to adhere to the recommended treatment follow-up recommendations for pregnancies of unknown location.
Additional studies will be needed to further validate the technology and determine its potential for clinical use. Next steps will include securing funding for larger studies, getting authorization from the Food and Drug Administration and establishing pathways for insurance reimbursement.
Ultimately, Fang and Clure want to give women and providers a safer, more convenient way to monitor pregnancies. By reducing the burden of repeated blood tests, they hope this technology can help ensure women receive timely medical care.
“Ectopic pregnancies are an incredibly important issue in women’s health,” said Clure. “We shouldn’t be living in a world where women are dying of ectopic pregnancies.”
New clinic provides supportive care in early pregnancy
Fang and Clure helped establish an early pregnancy clinic at CU Anschutz to provide in-person and telehealth appointments for patients experiencing pregnancy-related concerns before the traditional first prenatal appointment at 10 to 12 weeks. The clinic focuses on early diagnosis, monitoring and treatment of complications, including pregnancies of unknown location. By evaluating patients earlier, they help identify potential complications before they become emergencies, allowing for medical management when appropriate rather than emergency surgery. The clinic also provides education and support during an often stressful and uncertain period of pregnancy. Fang and Clure hopes potentially incorporate at-home hormone monitoring to improve access, particularly for patients in rural communities.
Key points:
CU Anschutz researchers are investigating whether at-home urine testing could help monitor hormone levels in women with pregnancy of unknown location.
The 31-participant pilot study found the urine and blood hCG levels were similar.
At-home monitoring could potentially reduce the burden of frequent clinic visits and blood draws.
Larger studies and regulatory authorization are needed before the technology can be used for this clinical purpose.
Researchers are also exploring earlier, more accessible care for women experiencing pregnancy complications.