Does Follow-up With Serum Beta Human Chorionic Gonadotropin (BhCG) Simplify Medical Abortion?

Not Applicable

Completed

• Conditions: Medical Abortion

• Registration Number: NCT00907725
• Lead Sponsor: Planned Parenthood League of Massachusetts

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-22
• Study First Submitted QC: 2009-05-22
• Study First Posted: 2009-05-25
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-08
• Last Update Posted: 2012-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 376

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Receipt of any additional intervention or follow-up beyond the one routinely scheduled follow-up ultrasound or follow-up BhCG draw	4 weeks

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction with follow-up method	4 weeks

Trial Locations

Locations (1)

Planned Parenthood League of Massachusetts; 🇺🇸 Boston, Massachusetts, United States