Clinical trial NCT01596972: The Role of a Semi-Quantitative Urine Pregnancy Test and Pregnancy Questionnaire After Uterine Evacuation for Undesired Pregnancy of Uncertain Location
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Follow-up After Uterine Evacuation
Lead sponsor: Planned Parenthood League of Massachusetts
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2012-05-11
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 1 week
Secondary outcomes:
measure: Patient Compliance With Each Follow-up Method
timeFrame: 2 weeks
measure: Patient Satisfaction With Each Follow-up Method
timeFrame: 1 week
Other outcomes:
Locations:
city: Boston
country: United States
facility: Planned Parenthood League of Massachusetts
state: Massachusetts
Study officials:
affiliation: Planned Parenthood League of Massachusetts
name: Principal Investigator, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: