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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

NCT01596972 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2014-07-01

Study results available
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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.

Conditions

  • Follow-up After Uterine Evacuation

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Principal Investigator, MD, MPH · Planned Parenthood League of Massachusetts

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-03-31
Completion
2013-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01596972 on ClinicalTrials.gov