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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
History of Changes
  Purpose

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: Open Label
Official Title: Follow-up With Serum BhCG Simplify Medical Abortion: A Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient satisfaction with follow-up method [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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
1
serum BhCG follow-up
 Other: serum BhCG follow-up
Subjects in this arm will receive medical abortion follow-up using BhCG blood draw
2
ultrasonographic follow-up
 Other: ultrasonographic follow-up
Subjects in this arm will receive medical abortion follow-up by ultrasound

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907725

Locations
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
Investigators
Principal Investigator: Principal Investigator Planned Parenthood
  More Information

No publications provided by Planned Parenthood League of Massachusetts

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Planned Parenthood League of Massachusetts
ClinicalTrials.gov Identifier: NCT00907725     History of Changes
Other Study ID Numbers: 2009p000363
Study First Received: May 22, 2009
Last Updated: May 8, 2012
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013