title: Randomized trial assessing home use of two pregnancy tests for determining early medical abortion outcomes at 3, 7 and 14days after mifepristone.
abstract: To evaluate the accuracy, feasibility and acceptability of two urine pregnancy tests in assessing abortion outcomes at three time points after mifepristone administration.
  
  
  
  This randomized trial enrolled women seeking early medical abortion at two hospitals in Vietnam. Investigators randomly allocated participants to at-home administration of a multilevel urine pregnancy test (MLPT) or a high sensitivity urine pregnancy test (HSPT) to assess their abortion outcomes. A baseline test was administered on the same day as mifepristone. Participants performed and interpreted results of pregnancy tests taken 3, 7 and 14days after mifepristone. Ultrasound exam determined continuing pregnancy.
  
  
  
  Six hundred women enrolled, and 300 received each test. A percentage of 97.4 (584) had follow-up, of whom 13 women had continuing pregnancies. The specificity of MLPT at detecting absence of continuing pregnancy was 63.9%, 90.4% and 97.1% at study day 3, 7 and 14. The specificity of HSPT was 6.0%, 19.8% and 62.2%, respectively. The positive predictive value (PPV) of MLPT at detecting continuing pregnancy was 6.4% at day 3 and rose to 46.7% at day 14. In contrast, the PPV for HSPT was 2.2% at day 3 and rose to 6.5% at day 14. At all three time points, the sensitivity and negative predictive values for both tests were 100.0%. Most women found their assigned tests easy to use and would prefer future home follow-up with a pregnancy test.
  
  
  
  The MLPT enables women to assess their abortion outcomes more reliably than with HSPT. With MLPT, women can know their outcomes as early as 3 days after mifepristone.
  
  
  
  Medical abortion service delivery with an MLPT to obtain a baseline (preabortion) human chorionic gonadotropin (hCG) estimate and a second follow-up MLPT 1 to 2 weeks later can establish whether there has been a drop in hCG, signifying absence of a continuing pregnancy. Used this way, MLPTs can enable women to assess their abortion status outside of a clinic setting and without serum hCG testing and/or ultrasound.
authors.affiliation: Gynuity Health Projects, New York, NY. Electronic address: jblum@gynuity.org.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Blum
authors.affiliation: Gynuity Health Projects, New York, NY.
authors.forename: Wendy R
authors.initials: WR
authors.lastname: Sheldon
authors.affiliation: Center for Research Consultancy in Reproductive Health, Ho Chi Minh City, Vietnam.
authors.forename: Nguyen Thi Nhu
authors.initials: NT
authors.lastname: Ngoc
authors.affiliation: Gynuity Health Projects, New York, NY.
authors.forename: Beverly
authors.initials: B
authors.lastname: Winikoff
authors.affiliation: Hung Vuong Hospital, Ho Chi Minh City, Vietnam.
authors.forename: Nguyen Thi Bach
authors.initials: NT
authors.lastname: Nga
authors.affiliation: Gynuity Health Projects, New York, NY.
authors.forename: Roxanne
authors.initials: R
authors.lastname: Martin
authors.affiliation: HocMon General District Hospital, Ho Chi Minh City, Vietnam.
authors.forename: Le
authors.initials: L
authors.lastname: Van Thanh
authors.affiliation: Gynuity Health Projects, New York, NY.
authors.forename: Paul D
authors.initials: PD
authors.lastname: Blumenthal
mesh_terms: D000020:Abortifacient Agents, Nonsteroidal / Q000008:administration & dosage*; D000028:Abortion, Induced / Q000379:methods*; D000293:Adolescent; D000328:Adult; D006063:Chorionic Gonadotropin / Q000652:urine*; D005260:Female; D006801:Humans; D008875:Middle Aged; D015735:Mifepristone / Q000008:administration & dosage*; D016595:Misoprostol / Q000627:therapeutic use; D011247:Pregnancy; D011258:Pregnancy Tests / Q000379:methods*; D014463:Ultrasonography; D014744:Vietnam; D055815:Young Adult
chemical_list: D000020:Abortifacient Agents, Nonsteroidal; D006063:Chorionic Gonadotropin; D016595:Misoprostol; D015735:Mifepristone
keywords: High sensitivity pregnancy test; Medical abortion; Multilevel pregnancy test; Semiquantitative pregnancy test; Task sharing; Task shifting