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

NCT ID: NCT00907725

Last Updated: 2012-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

376 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Medical Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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1

serum BhCG follow-up

Group Type OTHER

serum BhCG follow-up

Intervention Type OTHER

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

2

ultrasonographic follow-up

Group Type OTHER

ultrasonographic follow-up

Intervention Type OTHER

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

Interventions

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serum BhCG follow-up

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

Intervention Type OTHER

ultrasonographic follow-up

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Society of Family Planning

OTHER

Sponsor Role collaborator

Planned Parenthood League of Massachusetts

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Principal Investigator

Role: PRINCIPAL_INVESTIGATOR

Planned Parenthood

Locations

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Planned Parenthood League of Massachusetts

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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):607-613. doi: 10.1097/AOG.0b013e3182839fda.

Reference Type DERIVED
PMID: 23635625 (View on PubMed)

Other Identifiers

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2009p000363

Identifier Type: -

Identifier Source: org_study_id

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