The Role of a Semi-Quantitative Urine Pregnancy Test and Pregnancy Questionnaire After Uterine Evacuation for Undesired Pregnancy of Uncertain Location
Completed · Not applicable
Conditions studied: Follow-up After Uterine Evacuation
In brief
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.
Key facts
- Study ID
- NCT01596972
- Run by
- Planned Parenthood League of Massachusetts
- People needed
- 51
- Starts
- 2012-06-01
- Expected to finish
- 2013-05-01
- Last updated by the study team
- 2014-07-01
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Planned Parenthood League of Massachusetts — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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