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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serum quantitative urine pregnancy test | Experimental | uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week |
|
| serum hCG | No Intervention | follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dBest semi-quantitative urine pregnancy test | Device | 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) |
| 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 |
| 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) |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Principal Investigator, MD, MPH | Planned Parenthood League of Massachusetts | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood League of Massachusetts | Boston | Massachusetts | 02215 | United States |
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Recruitment period: July 2012-March 2013 Outpatient clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Serum Quantitative Urine Pregnancy Test | uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week dBest semi-quantitative urine pregnancy test: 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) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 1 week |
| FG001 | Serum hCG | follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Serum Quantitative Urine Pregnancy Test | uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week dBest semi-quantitative urine pregnancy test: 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) |
| BG001 | Serum hCG | follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | The numbers below report self-described RACE of participants. Additionally, though, 3 participants in the Serum HCG arm and 5 participants in the serum quantitative urine pregnancy test arm also self-identified as having a Hispanic Ethnicity. | Number | participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The number of participants analyzed in the serum hCG arm were the number of participants who started in this arm minus the number who were discontinued from the study per MD decision (total N in analysis was therefore 17). | Posted | Number | participants | 1 week |
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| Secondary | Patient Compliance With Each Follow-up Method | Posted | Number | participants | 2 weeks |
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| Secondary | 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) | Posted | Number | participants | 1 week |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Serum Quantitative Urine Pregnancy Test | uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week dBest semi-quantitative urine pregnancy test: 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) | 0 | 25 | 0 | 25 | ||
| EG001 | Serum hCG | follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire | 0 | 26 | 0 | 26 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research and Training | Planned Parenthood League of Massachusetts | 617.616.1600 | agoldberg@pplm.org |
| Male |
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| Black/African American |
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| Asian |
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| Multiracial |
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| Other |
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| Units | Counts |
|---|---|
| Participants |
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