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

NCT00907725 | Completed

• 1 other identifier: 2009p000363
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 1

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.

Conditions

Medical Abortion

Keywords

medical abortion; serum BhCG follow-up; ultrasonographic follow-up; follow-up methods

Outcome Measures

Primary Outcomes (1)

• Receipt of any additional intervention or follow-up beyond the one routinely scheduled follow-up ultrasound or follow-up BhCG draw

  4 weeks

Secondary Outcomes (1)

• Patient satisfaction with follow-up method

  4 weeks

Study Arms (2)

1

OTHER

serum BhCG follow-up

Other: serum BhCG follow-up

2

OTHER

ultrasonographic follow-up

Other: ultrasonographic follow-up

Interventions

serum BhCG follow-up OTHER

Subjects in this arm will receive medical abortion follow-up using BhCG blood draw

1

ultrasonographic follow-up OTHER

Subjects in this arm will receive medical abortion follow-up by ultrasound

2

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Planned Parenthood League of Massachusetts: lead
• Society of Family Planning: collaborator

Study Sites (1)

Planned Parenthood League of Massachusetts

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Dayananda I, Maurer R, Fortin J, Goldberg AB. Medical abortion follow-up with serum human chorionic gonadotropin compared with ultrasonography: a randomized controlled trial. Obstet Gynecol. 2013 Mar;121(3):607-613. doi: 10.1097/AOG.0b013e3182839fda.

  PMID: 23635625 DERIVED

Study Officials

• Principal Investigator

  Planned Parenthood

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2009
• First Posted: May 25, 2009
• Study Start: May 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 10, 2012

Record last verified: 2012-05

Locations

US (1)