Human Chorionic Gonadotropin (hCG) Trend After Medication Abortion

NCT02179944 | Completed

• 2 other identifiers: 2014p000824SFPRF14-20
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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. 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. 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. 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.

Conditions

Undesired Pregnancy

Keywords

medication abortion; serum hCG

Outcome Measures

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

  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 Outcomes (1)

• difference in rate of hCG decline based on initial gestational age

  10 days after misoprostol administration

Other Outcomes (1)

• how soon after initiating medication abortion a semi-quantitative urine pregnancy test can detect completed abortion

  10 days

Study Arms (1)

Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients seeking medication abortion from an outpatient health center

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Planned Parenthood League of Massachusetts: lead

Study Sites (1)

Planned Parenthood

Boston, Massachusetts, 02215, United States

Location

Study Officials

• Principal Investigator, MD, MPH

  PPLM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2014
• First Posted: July 2, 2014
• Study Start: July 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: August 17, 2015

Record last verified: 2015-08

Locations

US (1)