The Role of a Semi-Quantitative Urine Pregnancy Test and Pregnancy Questionnaire After Uterine Evacuation for Undesired Pregnancy of Uncertain Location

Study Overview
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Brief Summary
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The primary aim of this study is to determine if a self-administered semi-quantitative urine pregnancy test and telephone pregnancy symptom questionnaire can reduce the percentage of women with a complete uterine evacuation who require a clinic or lab visit to confirm completion. The investigators hypothesize that women with complete uterine evacuation will be less likely to require a follow-up clinic or lab visit by using a standardized pregnancy questionnaire and home SQ-UPT, than by using serum hCG as the objective measure of completion.

Official Title
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The Role of a Semi-Quantitative Urine Pregnancy Test and Pregnancy Questionnaire After Uterine Evacuation for Undesired Pregnancy of Uncertain Location: A Pilot Randomized Controlled Trial

Conditions
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Follow-up After Uterine Evacuation

Intervention / Treatment
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* Device: dBest semi-quantitative urine pregnancy test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 18 years or older with an undesired pregnancy < 6 weeks gestation Women with a positive urine pregnancy test Proficiency in English Working phone and subject willing to be contacted by phone. Agreeing to surveys regarding demographics, follow-up preferences, and satisfaction with assigned follow-up method Exclusion Criteria: Women with presence of a yolk sac or crown rump length visualized on ultrasound Women with a gestational sac greater than 13mm [11] High Suspicion for ectopic pregnancy o Sign: Concerning adnexal mass seen on ultrasound in conjunction with pelvic pain and/or vaginal spotting Hemodynamic instability o Signs: heavy vaginal bleeding, hypotension, tachycardia Pelvic Infection o Signs: pain or fever Medical conditions that contraindicate uterine evacuation according to PPLM clinic policy o These include but are not limited to: a bleeding disorder or anticoagulation, significant cardiac disease, renal or liver failure, IUD in situ that cannot be removed Unwilling or unable to comply with study follow-up procedures Being in a situation where receiving phone calls or additional contact with research staff may endanger the privacy or safety of the subject (e.g. situations of domestic violence or abuse) Inability to give informed consent Previous participation in this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Serum quantitative urine pregnancy test<br>uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week | Device: dBest semi-quantitative urine pregnancy test<br>* The dBest® semi-quantitative urine pregnancy test (Figure 2) is a graduated urine pregnancy test with five different levels of sensitivity: 25 IU/L, 100 IU/L, 500 IU/L, 2000 IU/L, 10000 IU/L. The test detects the level of serum hCG that corresponds to the range between that level and the level above it, i.e. the test would be positive at 500 if the hCG was either 501 or 1999. The tool was validated in a US sample of 196 women, where there was a correlation of 69% between urine hCG and serum hCG. Furthermore, the test had a 10% false negative rate (i.e. recording a level two gradations below the serum level) and a 6% false positive rate (i.e. recording a level two gradations above the serum level)<br>|
| No Intervention: serum hCG<br>follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Women in Each Group Who Require a Return Visit to the Clinic for a Serum hCG Measurement, Ultrasound or Clinical Examination at One Week to Confirm Complete Evacuation |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Compliance With Each Follow-up Method |  | 2 weeks | 
| Patient Satisfaction With Each Follow-up Method | Patient satisfaction with each follow-up method was assessed with the following survey questions: How satisfied are you with [name of follow-up method]? (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied) | 1 week |