N/A
N=51
The Role of a Semi-Quantitative Urine Pregnancy Test and Pregnancy Questionnaire After Uterine Evacuation for Undesired Pregnancy of Uncertain Location
Follow-up After Uterine Evacuation
Bottom Line
View on ClinicalTrials.gov: NCT01596972 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: 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 — 3; 17 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- dBest semi-quantitative urine pregnancy test (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Planned Parenthood League of Massachusetts
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
3; 17 | — |
| SECONDARY Patient Compliance With Each Follow-up Method |
24; 12 | — |
| SECONDARY Patient Satisfaction With Each Follow-up Method |
22; 6 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01596972). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.