Human Chorionic Gonadotropin (hCG) Trend After Medication Abortion
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|ClinicalTrials.gov Identifier: NCT02179944|
Recruitment Status : Completed
First Posted : July 2, 2014
Last Update Posted : August 17, 2015
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.
- 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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||66 participants|
|Official Title:||Human Chorionic Gonadotropin (hCG) Trend After Medication Abortion: A Prospective Physiologic Study|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
- Percent serum hCG decline from Day 1 to Day 3, from Day 1 to Day 5, and from Day 1 to Day 7-10 [ Time Frame: 10 days from misoprostol administration ]blood sample collection for hCG testing on Day 3, Day 5 and Day 7-10 (Day 1 is day of mifepristone administration)
- difference in rate of hCG decline based on initial gestational age [ Time Frame: 10 days after misoprostol administration ]blood sample collection for hCG testing on Day 3, Day 5 and Day 7-10 (Day 1 is day of mifepristone administration)
- how soon after initiating medication abortion a semi-quantitative urine pregnancy test can detect completed abortion [ Time Frame: 10 days ]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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02179944
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Principal Investigator, MD, MPH||PPLM|