Trial Outcomes & Findings for The Role of a Semi-Quantitative Urine Pregnancy Test and Pregnancy Questionnaire After Uterine Evacuation for Undesired Pregnancy of Uncertain Location (NCT NCT01596972)

NCT ID: NCT01596972

Last Updated: 2014-07-01

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 51 participants
• Primary outcome timeframe: 1 week
• Results posted on: 2014-07-01

Participant Flow

Recruitment period: July 2012-March 2013 Outpatient clinic

Participant milestones

Measure	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)	Serum hCG follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
Overall Study STARTED	25	26
Overall Study COMPLETED	24	12
Overall Study NOT COMPLETED	1	14

Reasons for withdrawal

Measure	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)	Serum hCG follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
Overall Study Physician Decision	1	9
Overall Study Lost to Follow-up	0	4
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Serum Quantitative Urine Pregnancy Test n=25 Participants 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)	Serum hCG n=26 Participants follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire	Total n=51 Participants Total of all reporting groups
Age, Continuous	25 years STANDARD_DEVIATION 5 • n=5 Participants	25 years STANDARD_DEVIATION 5 • n=7 Participants	25 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White/European American	14 participants n=5 Participants	14 participants n=7 Participants	28 participants n=5 Participants
Race/Ethnicity, Customized Black/African American	5 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants
Race/Ethnicity, Customized Asian	2 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants
Race/Ethnicity, Customized Multiracial	2 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants
Race/Ethnicity, Customized Other	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	26 participants n=7 Participants	51 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week

Population: 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).

Outcome measures

Measure	Serum Quantitative Urine Pregnancy Test n=24 Participants 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)	Serum hCG n=17 Participants follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
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	3 participants	17 participants

SECONDARY outcome

Timeframe: 2 weeks

Outcome measures

Measure	Serum Quantitative Urine Pregnancy Test n=24 Participants 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)	Serum hCG n=17 Participants follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
Patient Compliance With Each Follow-up Method	24 participants	12 participants

SECONDARY outcome

Timeframe: 1 week

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)

Outcome measures

Measure	Serum Quantitative Urine Pregnancy Test n=24 Participants 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)	Serum hCG n=17 Participants follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
Patient Satisfaction With Each Follow-up Method	22 participants	6 participants

Adverse Events

Serum Quantitative Urine Pregnancy Test

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serum hCG

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Research and Training

Planned Parenthood League of Massachusetts

Phone: 617.616.1600

Email: agoldberg@pplm.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place