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Completed

NCT Number: NCT02179944

Human Chorionic Gonadotropin (hCG) Trend After Medication Abortion

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.

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Key information

Conditions

Undesired Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Planned Parenthood

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Planned Parenthood League of Massachusetts

Other

Registry information

Official study title

Human Chorionic Gonadotropin (hCG) Trend After Medication Abortion: A Prospective Physiologic Study

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 2, 2014
Registry last updated
Aug 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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