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

NCT01596972 | Completed Results

• 1 other identifier: 2012P000576
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Follow-up After Uterine Evacuation

Outcome Measures

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

  1 week

Secondary Outcomes (2)

• Patient Compliance With Each Follow-up Method

  2 weeks

• Patient Satisfaction With Each Follow-up Method

  1 week

Study Arms (2)

Serum quantitative urine pregnancy test

EXPERIMENTAL

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

serum hCG

NO INTERVENTION

follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire

Interventions

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)

Serum quantitative urine pregnancy test

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Planned Parenthood League of Massachusetts: lead
• Society of Family Planning: collaborator

Study Sites (1)

Planned Parenthood League of Massachusetts

Boston, Massachusetts, 02215, United States

Location

Results Point of Contact

• Title: Director of Clinical Research and Training
• Organization: Planned Parenthood League of Massachusetts

agoldberg@pplm.org

617.616.1600

Study Officials

• Principal Investigator, MD, MPH

  Planned Parenthood League of Massachusetts

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2012
• First Posted: May 11, 2012
• Study Start: June 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 1, 2014
• Results First Posted: July 1, 2014

Record last verified: 2014-06

Locations

US (1)