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Completed

NCT Number: NCT01596972

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

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.

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Key information

Conditions

Follow-up After Uterine Evacuation

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Planned Parenthood League of Massachusetts

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dBest semi-quantitative urine pregnancy test

Device

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)

Primary outcomes

  1. 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: 1 week

Secondary outcomes

  1. Patient Compliance With Each Follow-up Method

    Time frame: 2 weeks

  2. Patient Satisfaction With Each Follow-up Method

    Time frame: 1 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)

Sponsors and collaborators

Lead sponsor

Planned Parenthood League of Massachusetts

Other

Collaborators

  • Society of Family Planning

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 11, 2012
Registry last updated
Jul 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.