Follow-up With Serum BhCG Simplify Medical Abortion: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 376
- Locations
- 2
- Primary Endpoint
- Receipt of any additional intervention or follow-up beyond the one routinely scheduled follow-up ultrasound or follow-up BhCG draw
Study Overview
Brief Summary
The purpose of this study is to evaluate if BhCG testing to determine the completion of medical abortion simplifies the medical abortion protocol. Investigators hypothesize that women randomized to ultrasonographic determination of completion of medical abortion will have MORE follow-up visits/interventions beyond standard protocol than those randomized to medical abortion follow-up with serum BhCG.
The investigators also hope to explore satisfaction with BhCG based follow-up among women seeking medical abortion. Investigators hypothesize that the majority of women who choose to follow-up with serum BhCG will be satisfied with this method of medical abortion follow-up.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pregnant women undergoing medical abortion
- •Proficiency in English
- •Working phone and willingness to be contacted by phone
- •Agreeing to surveys regarding demographics, follow-up preferences, and satisfaction with chosen follow-up method
Exclusion Criteria
- •Concern for ectopic pregnancy or unable to document intrauterine pregnancy
- •Clinical instability or signs of pelvic infection
- •Medical conditions that contraindicate medical abortion
- •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)
- •Inability to give informed consent
- •Previous participation in this study
Outcomes
Primary Outcomes
Receipt of any additional intervention or follow-up beyond the one routinely scheduled follow-up ultrasound or follow-up BhCG draw
Time Frame: 4 weeks
Secondary Outcomes
- Patient satisfaction with follow-up method(4 weeks)