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

Medical Abortion Clinical Trial

Official title:

Follow-up With Serum BhCG Simplify Medical Abortion: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00907725
• Other study ID #: 2009p000363
• Status: Completed
• Phase: N/A
• First received: May 22, 2009
• Last updated: May 8, 2012
• Start date: May 2009
• Est. completion date: June 2010

Study information

• Verified date: May 2012
• Source: Planned Parenthood League of Massachusetts
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Medical Abortion

Intervention

Other:
• serum BhCG follow-up
Subjects in this arm will receive medical abortion follow-up using BhCG blood draw
• ultrasonographic follow-up
Subjects in this arm will receive medical abortion follow-up by ultrasound

Locations

Country	Name	City	State
United States	Planned Parenthood League of Massachusetts	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Planned Parenthood League of Massachusetts	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Receipt of any additional intervention or follow-up beyond the one routinely scheduled follow-up ultrasound or follow-up BhCG draw		4 weeks	No
Secondary	Patient satisfaction with follow-up method		4 weeks	No