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Trial record 1 of 1 for:    NCT00907725
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Does Follow-up With Serum Beta Human Chorionic Gonadotropin (BhCG) Simplify Medical Abortion?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00907725
Recruitment Status : Completed
First Posted : May 25, 2009
Last Update Posted : May 10, 2012
Society of Family Planning
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Medical Abortion Other: serum BhCG follow-up Other: ultrasonographic follow-up Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 376 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Follow-up With Serum BhCG Simplify Medical Abortion: A Randomized Controlled Trial
Study Start Date : May 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Patient satisfaction with follow-up method [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00907725

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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
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Principal Investigator: Principal Investigator Planned Parenthood
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Planned Parenthood League of Massachusetts Identifier: NCT00907725    
Other Study ID Numbers: 2009p000363
First Posted: May 25, 2009    Key Record Dates
Last Update Posted: May 10, 2012
Last Verified: May 2012
Keywords provided by Planned Parenthood League of Massachusetts:
medical abortion
serum BhCG follow-up
ultrasonographic follow-up
follow-up methods