Undesired Pregnancy Clinical Trial
Official title:
Human Chorionic Gonadotropin (hCG) Trend After Medication Abortion: A Prospective Physiologic Study
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:
1. 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.
2. 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.
3. 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.
| Status | Completed |
| Enrollment | 66 |
| Est. completion date | March 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | Planned Parenthood | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Planned Parenthood League of Massachusetts |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | No |
| Primary | 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 | No |
| Secondary | 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 | No |
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