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

Information source: Planned Parenthood League of Massachusetts
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Medical Abortion

Intervention: serum BhCG follow-up (Other); ultrasonographic follow-up (Other)

Phase: N/A

Status: Completed

Sponsored by: Planned Parenthood League of Massachusetts

Official(s) and/or principal investigator(s):
Principal Investigator, Principal Investigator, Affiliation: Planned Parenthood

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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome: Receipt of any additional intervention or follow-up beyond the one routinely scheduled follow-up ultrasound or follow-up BhCG draw

Secondary outcome: Patient satisfaction with follow-up method

Eligibility

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Female.

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

Locations and Contacts

Planned Parenthood League of Massachusetts, Boston, Massachusetts 02215, United States
Additional Information

Starting date: May 2009
Last updated: May 8, 2012

Page last updated: August 23, 2015

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