At-Home Urine Test for Ectopic Pregnancy

(CONNECT Trial)

Overseen By Jocelyn Phipers, NP

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Hormonal contraception

Disqualifiers: Renal disease, Diabetes, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

35 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{4 6 7 8 9}

How 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. ^{2 3 5 10 11}

Eligibility 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)

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

Treatment Details

Interventions

• At-home quantitative urine b-hCG test

Trial Overview 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.

Participant Groups

Group I: PUL: Pregnancy unknown location diagnosis Active Control 1 Intervention

Pregnant patients with unknown location diagnosis will use the pregnancy test device

Group II: CNTRL: Non-pregnant control patients Placebo Group 1 Intervention

Non-pregnant patients will use the pregnancy test device

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Findings from Research

In a study of 80 women, urine hCG levels were found to be well correlated with serum hCG levels, especially after correcting for creatinine, suggesting urine tests could be a convenient alternative for monitoring pregnancy outcomes.

While serum hCG measurements are more reliable for predicting pregnancy outcomes in cases of unknown location, urine hCG tests may still help identify low-risk cases, indicating their potential role in clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential use of urinary hCG measurements in the management of pregnancies of unknown location. Bobdiwala, S., Harvey, R., Abdallah, Y., et al.[2022]

The study established that an immunomagnetic reduction (IMR) assay can accurately measure total hCGβ concentrations in urine, showing a strong correlation with serum levels, which could provide a non-invasive alternative for diagnosing ectopic pregnancy.

With a calibration curve ranging from 0.01 ng/mL to 10,000 ng/mL and excellent correlation coefficients (R(2)=0.994 for urine vs serum), the IMR assay demonstrates potential for point-of-care testing in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative analysis of total β-subunit of human chorionic gonadotropin concentration in urine by immunomagnetic reduction to assist in the diagnosis of ectopic pregnancy. Chen, CY., Hwu, YM., Chen, CP., et al.[2018]

In a study of 51 patients with suspected ectopic pregnancy, serum hCG measurements were found to be the most accurate test for diagnosis, with an efficiency of 86%.

The urinary hCG tube test, while slightly less accurate at 80%, is recommended as a practical screening tool due to its ease of use, low cost, and quick results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Braunstein, GD., Asch, RH.[2019]

The modified Tandem Icon urine test for human chorionic gonadotrophin was effectively used by clinicians to evaluate 51 women with suspected ectopic pregnancy, showing no negative results in actual cases of ectopic or ongoing pregnancy.

This test significantly reduces the need for hospital observation and diagnostic surgery, as a negative result can reliably exclude the diagnosis of ectopic pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A sensitive bedside urine test for human chorionic gonadotrophin in suspected ectopic pregnancy. Hofmeyr, GJ., Rodrigues, FA., Koll, PC.[2014]

In a study of 175 patients suspected of having an ectopic pregnancy, 95 were confirmed to have the condition, and all tested positive for hCG in both blood and urine, indicating the reliability of hCG testing for diagnosis.

Quantitative assays for intact hCG in blood showed a strong correlation with urine levels, but urinary hCG quantification is not recommended due to variability in dilution, making blood tests more reliable for diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood or urine measurement of human chorionic gonadotropin for detection of ectopic pregnancy? A comparative study of quantitative and qualitative methods in both fluids. Norman, RJ., Buck, RH., Rom, L., et al.[2009]

The Clearblue Digital Pregnancy Test (CBDPT) achieved 100% accuracy in detecting hCG at a concentration typical of early pregnancy, significantly outperforming five other over-the-counter pregnancy tests, which had accuracy rates ranging from 65.8% to 87.5%.

All participants (100%) felt 'very certain' or 'certain' about the CBDPT results, while only 40.3% to 58.3% felt the same about the other tests, highlighting the advantage of digital readings in consumer confidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of accuracy and certainty of results of six home pregnancy tests available over-the-counter. Tomlinson, C., Marshall, J., Ellis, JE.[2008]

The modified ICON II hCG pregnancy test demonstrated high sensitivity and specificity for detecting hCG in urine, with a qualitative lower limit of detection as low as 0.30 IU/l, making it suitable for field studies on fetal loss.

In an 11-month study involving 494 women in rural Bangladesh, the assay effectively detected 330 pregnancies and 93 fetal losses, showing that it can provide reliable early pregnancy diagnosis comparable to laboratory tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A commercial pregnancy test modified for field studies of fetal loss. Holman, DJ., Rasheed, FN., Stroud, CM., et al.[2019]

Only two out of six home-use urine hCG tests and one out of two professional-use tests accurately detected hCG levels as low as the claimed 25 mIU/ml, highlighting significant variability in test sensitivity.

The inadequate performance of these point-of-care urine hCG tests in hospitals could lead to misdiagnosis and potentially harmful procedures for early pregnant women, emphasizing the need for blood tests as the gold standard for pregnancy diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of qualitative urinary hCG assays. Nickmans, S., Vermeersch, P., Van Eldere, J., et al.[2016]

The Siemens Immulite test is the only assay that effectively detects degraded forms of hCG in urine, which is important for accurate pregnancy testing and monitoring cancer patients.

Quantitative urine hCG testing can confirm false positive serum hCG results, as demonstrated in 3 out of 80 clinical cases, highlighting its potential utility in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need for a quantitative urine hCG assay. Cole, LA., Khanlian, SA.[2009]

The beta-HCG serum test was highly effective, showing positive results in 96% of patients suspected of having an ectopic pregnancy, compared to only 30% for urine tests and 60% for culdocentesis.

This study highlights the importance of the beta-HCG test as a reliable diagnostic tool for ectopic pregnancy, suggesting it should be prioritized in clinical assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assay of human chorionic gonadotrophin in the patient with a suspected ectopic pregnancy. Pather, R., Moodley, J., Norman, RJ.[2014]

A highly sensitive urine test for detecting human chorionic gonadotropin (hCG) was able to identify all 15 cases of ectopic pregnancy in a study of 107 patients, demonstrating its effectiveness as a diagnostic tool.

In a follow-up study of 94 patients with confirmed ectopic pregnancy, the urine test was positive in 90 cases (96%), suggesting it is a reliable screening method for early detection of ectopic pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A sensitive urine pregnancy test as an aid in the diagnosis of ectopic pregnancy. Nordenskjöld, F., Ahlgren, M., Erreth, L., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

The potential use of urinary hCG measurements in the management of pregnancies of unknown location. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

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]

3. United States pubmed.ncbi.nlm.nih.gov

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]

4. South Africa pubmed.ncbi.nlm.nih.gov

A sensitive bedside urine test for human chorionic gonadotrophin in suspected ectopic pregnancy. [2014]

5. United States pubmed.ncbi.nlm.nih.gov

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]

6. England pubmed.ncbi.nlm.nih.gov

Comparison of accuracy and certainty of results of six home pregnancy tests available over-the-counter. [2008]

7. Netherlands pubmed.ncbi.nlm.nih.gov

A commercial pregnancy test modified for field studies of fetal loss. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Performance of qualitative urinary hCG assays. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

The need for a quantitative urine hCG assay. [2009]

10. South Africa pubmed.ncbi.nlm.nih.gov

Assay of human chorionic gonadotrophin in the patient with a suspected ectopic pregnancy. [2014]

11. United States pubmed.ncbi.nlm.nih.gov

A sensitive urine pregnancy test as an aid in the diagnosis of ectopic pregnancy. [2019]