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OpenTrials
Completed

NCT Number: NCT00907725

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

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.

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Key information

Conditions

Medical Abortion

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Planned Parenthood League of Massachusetts

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

serum BhCG follow-up

Other

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

ultrasonographic follow-up

Other

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

Primary outcomes

  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 outcomes

  1. Patient satisfaction with follow-up method

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Planned Parenthood League of Massachusetts

Other

Collaborators

  • Society of Family Planning

Registry information

Official study title

Follow-up With Serum BhCG Simplify Medical Abortion: A Randomized Controlled Trial

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 25, 2009
Registry last updated
May 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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