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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
Sponsor:
Information provided by (Responsible Party):
Planned Parenthood League of Massachusetts

Brief Summary:

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.


Condition or disease
Undesired Pregnancy

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Study Type : Observational
Actual Enrollment : 66 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
Participants



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)


Other Outcome Measures:
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
adult patients seeking medication abortion from an outpatient health center
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
Planned Parenthood
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Planned Parenthood League of Massachusetts
Investigators
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Principal Investigator: Principal Investigator, MD, MPH PPLM

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Responsible Party: Planned Parenthood League of Massachusetts
ClinicalTrials.gov Identifier: NCT02179944     History of Changes
Other Study ID Numbers: 2014p000824
SFPRF14-20 ( Other Grant/Funding Number: Society for Family Planning Research Fund )
First Posted: July 2, 2014    Key Record Dates
Last Update Posted: August 17, 2015
Last Verified: August 2015
Keywords provided by Planned Parenthood League of Massachusetts:
medication abortion
serum hCG
Additional relevant MeSH terms:
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Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs