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

This study has been completed.
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Planned Parenthood League of Massachusetts
ClinicalTrials.gov Identifier:
NCT00907725
First received: May 22, 2009
Last updated: May 8, 2012
Last verified: May 2012

May 22, 2009
May 8, 2012
May 2009
June 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00907725 on ClinicalTrials.gov Archive Site
Patient satisfaction with follow-up method [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Does Follow-up With Serum Beta Human Chorionic Gonadotropin (BhCG) Simplify Medical Abortion?
Follow-up With Serum BhCG Simplify Medical Abortion: A Randomized Controlled Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Medical Abortion
  • Other: serum BhCG follow-up
    Subjects in this arm will receive medical abortion follow-up using BhCG blood draw
  • Other: ultrasonographic follow-up
    Subjects in this arm will receive medical abortion follow-up by ultrasound
  • 1
    serum BhCG follow-up
    Intervention: Other: serum BhCG follow-up
  • 2
    ultrasonographic follow-up
    Intervention: Other: ultrasonographic follow-up
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):607-13. doi: 10.1097/AOG.0b013e3182839fda.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
376
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Female
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00907725
2009p000363
No
Planned Parenthood League of Massachusetts
Planned Parenthood League of Massachusetts
Society of Family Planning
Principal Investigator: Principal Investigator Planned Parenthood
Planned Parenthood League of Massachusetts
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP