New Rapid Test to Detect Your Risk of Miscarriage and Ectopic Pregnancy

You want answers immediately when you are worried that something might be wrong with your pregnancy. That is why a new rapid test, done in the doctor’s office, at your bedside in the emergency room, or maybe even in your own home, is such a game changer. Learn more about the ROM Plus Test and how it may help you get answers faster and more easily about your risk for miscarriage or ectopic pregnancy when you have early pregnancy bleeding.

Healthcare providers already use the ROM (short for rupture of membranes) Plus Test to tell whether a pregnant person’s water has broken. Breaking your water is the same as rupturing your membranes (ROM). ROM happens when your amniotic sac breaks or springs a leak. It usually occurs just before or during labor, at the end of pregnancy. However, it is not always clear when someone’s water has broken, so healthcare providers use the ROM Plus test to help them make the diagnosis.

The ROM Plus test, the only U.S. Food and Drug Administration-approved test for ROM detects two proteins within amniotic fluid: alpha fetal protein (AFP) and insulin-like growth factor–binding protein 1 (IGFBP-1). If your water has broken, these two substances normally found in the amniotic fluid will also be in your vagina and around your cervix (the opening to your uterus). AFP and IGFB-1 are not present in the vaginal secretions of pregnant people whose water has not broken, so their ROM Plus Test would be negative.

It turns out that the ROM Plus Test may also answer questions about your risk of miscarriage or having an ectopic pregnancy. First-trimester bleeding occurs in 20–40 percent of pregnancies and accounts for almost 500,000 emergency department (ED) visits in the United States annually. The most common causes of first-trimester bleeding are threatened miscarriage and early pregnancy loss.

Prior studies have shown more AFP in vaginal blood than in maternal serum. Therefore, finding elevated levels of AFP in vaginal blood (by testing with the ROM Plus Test) can indicate the presence of dissolved fetal tissue. The presence of dissolved fetal tissue (detected as a positive ROM Plus Test) can help confirm a pregnancy loss (one that will not continue).

While less common than miscarriage, ectopic pregnancies also cause first-trimester bleeding and serious health consequences for pregnant people if not caught early enough. An ectopic pregnancy is a pregnancy that implants outside of the uterus, most commonly in the fallopian tubes. Unfortunately, not all pregnant women with first-trimester bleeding are far enough along in their pregnancy to see where the pregnancy is located. Instead, their pregnancy care provider can only tell them that they have a “pregnancy of unknown location” – a scary and confusing diagnosis to have to process. The signs of a ruptured ectopic pregnancy can also be hard to recognize – for both providers and patients.

But, the ROM plus test might detect whether or not there was any AFP or IGFBP-1 present. A negative test result could reassure you that you do not have an ectopic pregnancy. The authors of the study published in December 2022 in the journal Obstetrics and Gynecology reported that the bedside test strip reliably and accurately identified whether or not there was fetal tissue present, even in cases of ectopic pregnancies. In the study, all three cases of ectopic pregnancy had negative vaginal blood test strip results. The researchers suggest that the ROM Plus Test will be a less expensive and more accessible way for clinicians and pregnant people to get more answers as to the location of their pregnancy when ruling out an ectopic pregnancy.

Another potential benefit of the test is that it can identify fetal tissue accurately in blood samples or on menstrual pads even 20 days after collection. So potentially, people could bring samples to their providers’ offices for testing, removing the need for urgent visits to emergency departments. In addition, with adequate patient education and counseling, people with a history of multiple miscarriages or a threatened miscarriage could be given test strips to take home with them to use for reassurance if they have further early pregnancy bleeding.

Secondly, for those people who live in rural areas or for whom accessing emergency care is challenging, being able to use at-home test strips to determine whether or not to seek medical attention would be very helpful. A final observation the researchers make is that, in light of more restrictive abortion regulations in the U.S., the ROM Plus Test could facilitate earlier miscarriage diagnosis, increasing the options and time available for people seek care for miscarriage management.

While no one is prepared for the scare of early pregnancy bleeding, rest assured that newer and improved tests, such as the ROM Plus Test, are now available. The information given by the ROM Plus Test can help you, and your provider make better-informed decisions about your risk of miscarriage or ectopic pregnancy. Talk to your healthcare provider about any early pregnancy bleeding you experience. Learning more about the testing options available can help you find a little more peace of mind – something all pregnant people will welcome.

Amy Harris
Amy Harris is a certified nurse-midwife with a Master's Degree in Maternal and Child Health from Harvard Chan School of Public Health. Her passions are health literacy and women's reproductive health. A recent two-year sabbatical with her family in Spain was the impetus for becoming a freelance women's health writer. An exercise nut, she is happiest outdoors and on adventures abroad.

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