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| ID | Type | Description | Link |
|---|---|---|---|
| SFPRF14-20 | Other Grant/Funding Number | Society for Family Planning Research Fund |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants |
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| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| how soon after initiating medication abortion a semi-quantitative urine pregnancy test can detect completed abortion | urine sample collection for hCG testing using semi-quantitative urine pregnancy test on Day 1, Day 3, Day 5 and Day 7-10 (Day 1 is day of mifepristone administration) | 10 days |
Inclusion Criteria:
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:
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
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adult patients seeking medication abortion from an outpatient health center
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| Name | Affiliation | Role |
|---|---|---|
| Principal Investigator, MD, MPH | PPLM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood | Boston | Massachusetts | 02215 | United States |
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