The Role of a Semi-Quantitative Urine Pregnancy Test and Pregnancy Questionnaire After Uterine Evacuation for Undesired Pregnancy of Uncertain Location
- Conditions
- Follow-up After Uterine Evacuation
- Interventions
- Device: dBest semi-quantitative urine pregnancy test
- Registration Number
- NCT01596972
- Lead Sponsor
- Planned Parenthood League of Massachusetts
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 51
- 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
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Women with presence of a yolk sac or crown rump length visualized on ultrasound
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Women with a gestational sac greater than 13mm [11]
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High Suspicion for ectopic pregnancy
o Sign: Concerning adnexal mass seen on ultrasound in conjunction with pelvic pain and/or vaginal spotting
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Hemodynamic instability
o Signs: heavy vaginal bleeding, hypotension, tachycardia
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Pelvic Infection
o Signs: pain or fever
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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
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Unwilling or unable to comply with study follow-up procedures
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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)
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Inability to give informed consent
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Previous participation in this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Serum quantitative urine pregnancy test dBest semi-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
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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)
Trial Locations
- Locations (1)
Planned Parenthood League of Massachusetts
🇺🇸Boston, Massachusetts, United States