Human Chorionic Gonadotropin (hCG) Trend After Medication Abortion
NCT ID: NCT02179944
Last Updated: 2015-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
66 participants
OBSERVATIONAL
2014-07-31
2015-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
Yes
Sponsors
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Planned Parenthood League of Massachusetts
OTHER
Responsible Party
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Principal Investigators
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Principal Investigator, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
PPLM
Locations
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Planned Parenthood
Boston, Massachusetts, United States
Countries
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Other Identifiers
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SFPRF14-20
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2014p000824
Identifier Type: -
Identifier Source: org_study_id
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