Human Chorionic Gonadotropin (hCG) Trend After Medication Abortion

Study Overview
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Brief Summary
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This project will be a prospective physiologic study. We will closely follow 60 medication abortion patients with serial repeat serum hCG and urine semi-quantitative hCG testing. We plan to recruit patients from two gestational age strata: ≤ 49 days and > 49 days. Study Objectives: To create a nomogram describing the change in serum hCG values in the first five days immediately following medication abortion with mifepristone and misoprostol. Specifically, we will describe the percent serum hCG decline from Day 1 (day of mifepristone) to Day 3 (day after misoprostol), from Day 1 to Day 5, and from Day 1 to Day 7-10. To explore whether there is a significant difference in the rate of hCG decline based on initial gestational age determined by ultrasound and initial serum hCG. To describe the correlation between semi-quantitative urine hCG test results and serum hCG values to determine how soon after initiating medication abortion the urine test can detect completed abortion. We hypothesize that among successful medication abortions, there will be a predictable trend with at least a 50% drop by Day 3 and 80% drop by Day 5.

Official Title
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Human Chorionic Gonadotropin (hCG) Trend After Medication Abortion: A Prospective Physiologic Study

Conditions
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Undesired Pregnancy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Desire for medication abortion for pregnancy termination AND Pregnancy confirmed by ultrasound and gestational age ≤ 63 days based on transvaginal ultrasound (TVUS) OR Positive high-sensitivity urine hCG and intrauterine pregnancy (IUP) not confirmed on TVUS Exclusion Criteria: Ineligibility for medication abortion at Planned Parenthood League of Massachusetts (PPLM) based on current PPLM clinical guidelines Initiation of medication abortion on Wednesday or Friday Failed pregnancy defined as: Crown-rump length ≥ 7mm and no heartbeat Mean sac diameter ≥ 25mm and no embryo Reasonable clinical suspicion for ectopic or molar pregnancy such as abnormal or concerning ultrasound findings Multiple gestation Age less than 18 years Prior participation in this study Anticipated inability to present for scheduled follow-up visits

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent serum hCG decline from Day 1 to Day 3, from Day 1 to Day 5, and from Day 1 to Day 7-10 | blood sample collection for hCG testing on Day 3, Day 5 and Day 7-10 (Day 1 is day of mifepristone administration) | 10 days from misoprostol administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in rate of hCG decline based on initial gestational age | blood sample collection for hCG testing on Day 3, Day 5 and Day 7-10 (Day 1 is day of mifepristone administration) | 10 days after misoprostol administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medication abortion, serum hCG