Clinical trial NCT02179944: Human Chorionic Gonadotropin (hCG) Trend After Medication Abortion
Official title: Human Chorionic Gonadotropin (hCG) Trend After Medication Abortion: A Prospective Physiologic Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Undesired Pregnancy
Keywords: medication abortion
serum hCG
Lead sponsor: Planned Parenthood League of Massachusetts
Sponsor class: OTHER
First posted: 2014-07-02
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients seeking medication abortion from an outpatient health center

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.


Eligibility 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

Primary outcomes:
measure: Percent serum hCG decline from Day 1 to Day 3, from Day 1 to Day 5, and from Day 1 to Day 7-10
timeFrame: 10 days from misoprostol administration
Secondary outcomes:
measure: difference in rate of hCG decline based on initial gestational age
timeFrame: 10 days after misoprostol administration
Other outcomes:
measure: how soon after initiating medication abortion a semi-quantitative urine pregnancy test can detect completed abortion
timeFrame: 10 days
Locations:
city: Boston
country: United States
facility: Planned Parenthood
state: Massachusetts
Study officials:
affiliation: PPLM
name: Principal Investigator, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: