Human Chorionic Gonadotropin (hCG) Trend After Medication Abortion

Completed

• Conditions: Undesired Pregnancy

• Registration Number: NCT02179944
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-30
• Study First Submitted QC: 2014-06-30
• Study Start: 2014-07
• Study First Posted: 2014-07-02
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-14
• Last Update Posted: 2015-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent serum hCG decline from Day 1 to Day 3, from Day 1 to Day 5, and from Day 1 to Day 7-10	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

Name	Time	Method
difference in rate of hCG decline based on initial gestational age	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)

Trial Locations

Locations (1)

Planned Parenthood; 🇺🇸 Boston, Massachusetts, United States