Follow-up After Uterine Evacuation
Conditions
Brief summary
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.
Interventions
DEVICEdBest 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)
Sponsors
Society of Family Planning
Planned Parenthood League of Massachusetts
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Compliance With Each Follow-up Method | 2 weeks | — |
| Patient Satisfaction With Each Follow-up Method | 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) |
Countries
United States
Participant flow
Recruitment details
Recruitment period: July 2012-March 2013 Outpatient clinic
Participants by arm
| Arm | Count |
|---|---|
| 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) | 25 |
| Serum hCG follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire | 26 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 4 |
| Overall Study | Physician Decision | 1 | 9 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Serum Quantitative Urine Pregnancy Test | Serum hCG | Total |
|---|---|---|---|
| Age, Continuous | 25 years STANDARD_DEVIATION 5 | 25 years STANDARD_DEVIATION 5 | 25 years STANDARD_DEVIATION 5 |
| Race/Ethnicity, Customized Asian | 2 participants | 4 participants | 6 participants |
| Race/Ethnicity, Customized Black/African American | 5 participants | 3 participants | 8 participants |
| Race/Ethnicity, Customized Multiracial | 2 participants | 4 participants | 6 participants |
| Race/Ethnicity, Customized Other | 2 participants | 1 participants | 3 participants |
| Race/Ethnicity, Customized White/European American | 14 participants | 14 participants | 28 participants |
| Region of Enrollment United States | 25 participants | 26 participants | 51 participants |
| Sex: Female, Male Female | 25 Participants | 26 Participants | 51 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 26 |
| serious Total, serious adverse events | 0 / 25 | 0 / 26 |
Outcome results
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
Time frame: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Serum Quantitative Urine Pregnancy Test | 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 |
| Serum hCG | 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 | 17 participants |
Secondary
Patient Compliance With Each Follow-up Method
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Serum Quantitative Urine Pregnancy Test | Patient Compliance With Each Follow-up Method | 24 participants |
| Serum hCG | Patient Compliance With Each Follow-up Method | 12 participants |
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)
Time frame: 1 week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Serum Quantitative Urine Pregnancy Test | Patient Satisfaction With Each Follow-up Method | 22 participants |
| Serum hCG | Patient Satisfaction With Each Follow-up Method | 6 participants |