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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

This study has been completed.
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Planned Parenthood League of Massachusetts
ClinicalTrials.gov Identifier:
NCT01596972
First received: May 8, 2012
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
Follow-up After Uterine Evacuation
 Device: dBest semi-quantitative urine pregnancy test

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Planned Parenthood League of Massachusetts:

Primary Outcome Measures:
  • 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 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • patient compliance with each follow-up method [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • patient satisfaction with each follow-up method [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: June 2012
Study Completion Date: May 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596972

Locations
United States, Massachusetts
Planned Parenthood League of Massachusetts
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Planned Parenthood League of Massachusetts
Society of Family Planning
Investigators
Principal Investigator: Principal Investigator, MD, MPH Planned Parenthood League of Massachusetts
  More Information

No publications provided

Responsible Party: Planned Parenthood League of Massachusetts
ClinicalTrials.gov Identifier: NCT01596972     History of Changes
Other Study ID Numbers: 2012P000576
Study First Received: May 8, 2012
Last Updated: May 13, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 23, 2013