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

Planned Parenthood League of Massachusetts

Status: Completed

Conditions: Follow-up After Uterine Evacuation

Treatments: Device: dBest semi-quantitative urine pregnancy test

Study type: Interventional

Funder types: Other

Identifiers

NCT01596972

2012P000576

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

51 participants in 2 patient groups

Serum quantitative urine pregnancy test

Experimental group

Description:

uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week

Treatment:

Device: dBest semi-quantitative urine pregnancy test

serum hCG

No Intervention group

Description:

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