Human Chorionic Gonadotropin (hCG) Trend After Medication Abortion

August 14, 2015 updated by: Planned Parenthood League of Massachusetts

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Planned Parenthood

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

adult patients seeking medication abortion from an outpatient health center

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
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)
10 days from misoprostol administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
10 days after misoprostol administration

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Planned Parenthood League of Massachusetts

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

June 30, 2014

First Submitted That Met QC Criteria

June 30, 2014

First Posted (ESTIMATE)

July 2, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

August 17, 2015

Last Update Submitted That Met QC Criteria

August 14, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014p000824
  • SFPRF14-20 (OTHER_GRANT: Society for Family Planning Research Fund)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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