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

This study has been completed.
Society of Family Planning
Information provided by (Responsible Party):
Planned Parenthood League of Massachusetts Identifier:
First received: May 22, 2009
Last updated: May 8, 2012
Last verified: May 2012

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.

Condition Intervention
Medical Abortion Other: serum BhCG follow-up Other: ultrasonographic follow-up

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Follow-up With Serum BhCG Simplify Medical Abortion: A Randomized Controlled Trial

Further study details as provided by Planned Parenthood League of Massachusetts:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Patient satisfaction with follow-up method [ Time Frame: 4 weeks ]

Enrollment: 376
Study Start Date: May 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
serum BhCG follow-up
Other: serum BhCG follow-up
Subjects in this arm will receive medical abortion follow-up using BhCG blood draw
ultrasonographic follow-up
Other: ultrasonographic follow-up
Subjects in this arm will receive medical abortion follow-up by ultrasound


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00907725

United States, Massachusetts
Planned Parenthood League of Massachusetts
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Planned Parenthood League of Massachusetts
Society of Family Planning
Principal Investigator: Principal Investigator Planned Parenthood
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Planned Parenthood League of Massachusetts Identifier: NCT00907725     History of Changes
Other Study ID Numbers: 2009p000363
Study First Received: May 22, 2009
Last Updated: May 8, 2012

Keywords provided by Planned Parenthood League of Massachusetts:
medical abortion
serum BhCG follow-up
ultrasonographic follow-up
follow-up methods

Additional relevant MeSH terms:
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs processed this record on September 21, 2017