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

The Role of a Semi-Quantitative Urine Pregnancy Test and Pregnancy Questionnaire After Uterine Evacuation for Undesired Pregnancy of Uncertain Location: A Pilot Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Follow-up After Uterine Evacuation
• Intervention / Treatment: Device: dBest semi-quantitative urine pregnancy test

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Planned Parenthood League of Massachusetts

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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)
No Intervention: serum hCG; follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Compliance With Each Follow-up Method		2 weeks
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)	1 week

Collaborators and Investigators

• Sponsor: Planned Parenthood League of Massachusetts
• Collaborators: Society of Family Planning
• Investigators: Principal Investigator: Principal Investigator, MD, MPH, Planned Parenthood League of Massachusetts

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: May 8, 2012
• First Submitted That Met QC Criteria: May 9, 2012
• First Posted (Estimate): May 11, 2012

Study Record Updates

• Last Update Posted (Estimate): July 1, 2014
• Last Update Submitted That Met QC Criteria: June 27, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 2012P000576