At-Home Urine Test for Ectopic Pregnancy
(CONNECT Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Colorado, Denver
Must not be taking: Hormonal contraception
Disqualifiers: Renal disease, Diabetes, Malignancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The goal of this pilot study is to assess the accuracy and precision of an at-home quantitative urine beta hCG (b-hCG) test in the management of pregnancy of unknown location (PUL).
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. However, if you are using hormonal contraception, you must have stopped it at least 3 months before participating.
What data supports the effectiveness of the at-home quantitative urine b-hCG test for detecting ectopic pregnancy?
Research shows that urine tests for human chorionic gonadotropin (hCG) can be practical and efficient for screening ectopic pregnancies, with one study noting an 80% efficiency rate for a urine hCG tube test. Although blood tests are more accurate, urine tests are easier, cheaper, and faster, making them a useful tool for initial screening.
12345Is the at-home urine test for ectopic pregnancy safe for humans?
The studies reviewed focus on the accuracy and sensitivity of urine tests for detecting pregnancy hormones, but they do not report any safety concerns for humans using these tests.
46789How does the at-home urine test for ectopic pregnancy differ from other treatments?
The at-home urine test for ectopic pregnancy is unique because it allows for the detection of the pregnancy hormone hCG (human chorionic gonadotropin) directly from urine at home, offering a convenient and non-invasive alternative to blood tests, which are typically more reliable but require a visit to a healthcare provider.
2351011Eligibility Criteria
The MIRA CONNECT Study is for individuals who are not pregnant (as controls) or have been diagnosed with a pregnancy of unknown location (PUL) needing regular monitoring. It excludes those on recent hormonal contraception, with very high initial hCG levels, night shift workers, diabetes patients, unstable patients at risk of ruptured ectopic pregnancy, those with renal disease or any cancer including hCG-secreting tumors.Inclusion Criteria
Non-pregnant (controls)
I am being monitored for PUL with regular hCG blood tests.
Exclusion Criteria
Use of hormonal contraception within last 3 months (controls)
Initial serum hCG level > 100,000 mIU/ml (cases)
Patients who work the night shift (controls)
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Initial Diagnosis and Setup
Initial diagnosis of pregnancy of unknown location and setup of Mira device
1 day
1 visit (in-person)
Testing Phase
Participants perform daily urine and serum hCG testing for 7 days
7 days
7 visits (in-person for serum testing), daily at-home urine testing
Follow-up
Participants are monitored for safety and effectiveness after testing phase
2 weeks
Participant Groups
This pilot study tests the accuracy and precision of an at-home urine test that measures beta hCG levels for managing pregnancies where the location is unknown. The aim is to see if this method can reliably monitor these conditions without frequent hospital visits.
2Treatment groups
Active Control
Placebo Group
Group I: PUL: Pregnancy unknown location diagnosisActive Control1 Intervention
Pregnant patients with unknown location diagnosis will use the pregnancy test device
Group II: CNTRL: Non-pregnant control patientsPlacebo Group1 Intervention
Non-pregnant patients will use the pregnancy test device
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of ColoradoAurora, CO
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Who Is Running the Clinical Trial?
University of Colorado, DenverLead Sponsor
References
The potential use of urinary hCG measurements in the management of pregnancies of unknown location. [2022]Multiple measurements of serum human chorionic gonadotropin (hCG) are used to predict the final pregnancy outcome for women with a pregnancy of unknown location (PUL) and monitor the management of ectopic pregnancy (EP). Urine-based testing would be more convenient and economical. This prospective cohort study involving 80 women assessed the degree of correlation between serum and urine hCG levels and whether urine hCG levels have the potential to impact clinical decision making in the management of women with a PUL. Paired urine and serum hCG measurements differed quite widely but were well correlated and the degree of correlation improved after creatinine correction. Although serial serum hCG measurements appear to be better for the overall prediction of pregnancy outcome in PUL (AUC 0.77-0.94 compared to corrected urine AUC 0.69-0.84), serial urine hCG measurements may have a role in identifying subtypes of low-risk PUL (AUC 0.83-0.84).
Quantitative analysis of total β-subunit of human chorionic gonadotropin concentration in urine by immunomagnetic reduction to assist in the diagnosis of ectopic pregnancy. [2018]The initial diagnosis of ectopic pregnancy depends on physical examination, ultrasound, and serial measurements of total β-subunit of human chorionic gonadotropin (hCGβ) concentrations in serum. The aim of this study was to explore the possibility of using quantitative analysis of total hCGβ in urine rather than in serum by immunomagnetic reduction (IMR) assay as an alternative method to diagnose an ectopic pregnancy.
Predictive value analysis of measurements of human chorionic gonadotropin, pregnancy specific beta 1-glycoprotein, placental lactogen, and cystine aminopeptidase for the diagnosis of ectopic pregnancy. [2019]The diagnostic utility of serum and urinary human chorionic gonadotropin (hCG) measurements and serum measurements of pregnancy-specific beta 1-glycoprotein (PSBG), placental lactogen, and cystine aminopeptidase (CAP) was prospectively studied in 51 consecutive patients with suspected ectopic pregnancy who underwent laparoscopy or laparotomy. CAP was not detected in the sera of any patient with ectopic pregnancy. False-positive results in each assay were found in patients with intrauterine pregnancy or missed abortion. The overall efficiency of the tests were: urine hCG slide test, 47%; urine hCG tube test, 80%; serum hCG, 86%; serum PSBG, 82%; and human placental lactogen, 60%. Although measurement of serum hCG by radioimmunoassay is the most accurate biochemical test in predicting the correct diagnosis in patients with suspected ectopic pregnancy, the relatively high efficiency of the urinary hCG tube test, coupled with its ease of performance, low cost, and rapid turnaround time, makes it the most practical screening test.
A sensitive bedside urine test for human chorionic gonadotrophin in suspected ectopic pregnancy. [2014]An ultrasensitive modification of the Tandem Icon urine test for human chorionic gonadotrophin was used by clinicians, without special training, in the evaluation of 51 women with suspected ectopic pregnancy. There were 2 false-positive results. No negative results occurred in the presence of ectopic or ongoing pregnancy. A negative result (the majority of cases) is useful for excluding the diagnosis of ectopic pregnancy. The need for observation in hospital and diagnostic surgery can be greatly reduced by the use of this test in the ward or outpatient department.
Blood or urine measurement of human chorionic gonadotropin for detection of ectopic pregnancy? A comparative study of quantitative and qualitative methods in both fluids. [2009]One hundred seventy-five patients with features of ectopic pregnancy were studied, of whom 95 were subsequently shown to have an ectopic pregnancy. Paired blood and urine samples were assayed for human chorionic gonadotropin (hCG) by two radioimmunoassays, one immunoradiometric assay for intact hCG and an immunoradiometric assay for free beta subunit that also detects the "beta core" of hCG in urine. Qualitative testing was also performed using the Tandem Icon method of immunoconcentration on a membrane. The quantitative results for intact hCG showed an approximately unitary relationship between concentrations in both fluids, with a close correlation (r = 0.84, gradient = 1.01). The qualitative tests for hCG in both serum and urine were positive in all patients with ectopic pregnancy. The Tandem Icon is equally useful in blood and urine, whereas quantitative assays are more reliable in the blood. Quantitation of urinary hCG is not recommended because of the variable dilution of the glycoprotein in this fluid.
Comparison of accuracy and certainty of results of six home pregnancy tests available over-the-counter. [2008]The aim of the study was to determine the accuracy of home pregnancy tests (HPTs) in detecting human chorionic gonadotrophin (hCG) in human female urine and consumer certainty in reading the results. The Clearblue Digital Pregnancy Test (CBDPT) was compared with five alternative over-the-counter (OTC) brands of HPT.
A commercial pregnancy test modified for field studies of fetal loss. [2019]We describe simple modifications to the ICON II hCG (URINE) pregnancy test to provide a sensitive and specific urinary assay for hCG in field studies of fetal loss. The modified assay had a qualitative lower limit of detection of 0.30 IU/l, a 50% qualitative limit of 0.61 IU/l, a 100% qualitative limit of 1.16 IU/l, and a quantitative limit of 0.80 IU/l. Coefficients of variation ranged from 9.9% to 21.1%. Parallelism was observed among serially diluted subject samples. We used the assay in an 11-month prospective study of fetal loss in rural Bangladesh in which urine samples were collected twice-weekly from 494 women; 330 pregnancies and 93 fetal losses were detected. The median time to a positive pregnancy diagnosis was day 26 from last menses. The modified assay provided qualitative detection of early pregnancy comparable to laboratory assays, and appears to be well suited for use in epidemiologic or rural-population fetal loss studies.
Performance of qualitative urinary hCG assays. [2016]Significant differences in the sensitivity of eight frequently used qualitative urine human chorionic gonadotropin (hCG) tests in Belgium were observed in this study. Although most manufacturers claimed to detect hCG levels as low as 25 mIU/ml, only two out of six tests for home use and one out of two tests for professional use only, achieved the claimed detection limit. According to a survey, we performed among 20 acute care hospitals, 80% of the surveyed hospitals claimed to use these types of hCG analysis in a diagnostic setting. Unsatisfactory performance of these point-of-care testing (POC) assays for urinary hCG could have major consequences in a hospital setting, exposing the early pregnant woman to harmful diagnostic and therapeutic procedures. Although qualitative urine hCG tests are rapid and convenient, determination of hCG in blood remains the gold standard for the diagnosis of pregnancy.
The need for a quantitative urine hCG assay. [2009]The USA uniquely does not use quantitative urine human chorionic gonadotropin (hCG) tests despite being invaluable in pregnancy testing and in monitoring cancer patients. We look at current hCG tests and their detection of the degraded forms of hCG predominant in urine. We examine levels of urinary hCG, its usefulness in pregnancy testing, and advantages of urine testing in false positive hCG cases and cancer cases.
Assay of human chorionic gonadotrophin in the patient with a suspected ectopic pregnancy. [2014]Assay for the beta-subunit of human chorionic gonadotrophin (HCG) in the serum of 50 patients in whom the diagnosis of an ectopic pregnancy was suspected was compared with other diagnostic methods. The urine pregnancy test was only positive in 30% and culdocentesis in 60%, whereas the beta-HCG test was positive in 96% of cases. A flow-chart for the management of the patient with a suspected ectopic pregnancy is outlined.
A sensitive urine pregnancy test as an aid in the diagnosis of ectopic pregnancy. [2019]A highly sensitive 2-hour tube test for the detection of human chorionic gonadotropin (hCG) in urine was compared with the more resource-demanding radioimmunoassay for hCG in serum as an aid in the diagnosis of ectopic pregnancy. In a first series of 107 patients with the possibility of ectopic pregnancy, the urine test was positive in 31 patients, including all 15 patients shown to have an ectopic pregnancy. In a second series of 113 consecutive patients with ectopic pregnancy, the highly sensitive test was performed in 94 patients. It was positive in 90 (96%). The median time of amenorrhea at diagnosis was 7 weeks, and only 15 patients suffered a rupture of the fallopian tube. A highly sensitive urinary test for hCG is recommended as a screening method for patients giving even the smallest indication of ectopic pregnancy.