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

Study Overview
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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.

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

Conditions
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Medical Abortion

Intervention / Treatment
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* Other: serum BhCG follow-up
* Other: ultrasonographic follow-up


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>serum BhCG follow-up | Other: serum BhCG follow-up<br>* Subjects in this arm will receive medical abortion follow-up using BhCG blood draw<br>|
| Other: 2<br>ultrasonographic follow-up | Other: ultrasonographic follow-up<br>* Subjects in this arm will receive medical abortion follow-up by ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Receipt of any additional intervention or follow-up beyond the one routinely scheduled follow-up ultrasound or follow-up BhCG draw |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with follow-up method |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medical abortion, serum BhCG follow-up, ultrasonographic follow-up, follow-up methods