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

Not Applicable
Completed
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Serum quantitative urine pregnancy testdBest semi-quantitative urine pregnancy testuterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week
Primary Outcome Measures
NameTimeMethod
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 Evacuation1 week
Secondary Outcome Measures
NameTimeMethod
Patient Compliance With Each Follow-up Method2 weeks
Patient Satisfaction With Each Follow-up Method1 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

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