title: Self-administered multi-level pregnancy tests in simplified follow-up of medical abortion in Tunisia.
abstract: This study was conducted to assess the efficacy and acceptability of using a multi-level pregnancy test (MLPT) combined with telephone follow-up for medical abortion in Tunisia, where the majority of providers are midwives.
  
  
  
  Four hundred and four women with gestational age ≤ 70 days' LMP seeking medical abortion at six study sites were enrolled in this open-label trial. Participants administered a baseline MLPT at the clinic prior to mifepristone administration and were asked to take a second MLPT at home and to call in its results before returning the day of their scheduled follow-up visit 10-14 days later.
  
  
  
  Almost all women with follow-up (97.1 %, n = 332/342) had successful abortions without the need for surgical intervention. The MLPT worked extremely well among women ≤63 days' LMP in ruling out ongoing pregnancy (negative predictive value (NPV) =100 % (n = 298/298)) and also detecting women with ongoing pregnancies (sensitivity = 100 %; 2/2) as needing follow-up due to non-declining hCG. Among women 64-70 days' LMP, the test also worked well in ruling out ongoing pregnancy (NPV = 96.9 % (n = 31/32) but not as well in terms of sensitivity (50 %), with only one of two ongoing pregnancies detected by MLPT as needing follow-up. Most women (95.1 %) found the MLPT to be very easy or easy to use and would consider using the MLPT again (97.4 %) if needed.
  
  
  
  Self-administered pre and post MLPT are very easy for women to use and accurate in assessing medical abortion success up to 63 days' LMP. MLPT use for medical abortion follow-up has the potential to facilitate task sharing services and eliminate the burden of routine in-person follow-up visits for the large majority of women. Additional research is warranted to explore the accuracy of the MLPT in identifying ongoing pregnancy among women with gestational ages > 63 days.
  
  
  
  This study was registered on May 13, 2010, on clinicaltrials.gov as NCT01150279 .
authors.affiliation: Gynuity Health Projects, 15 East 26th Street, Suite 801, New York, NY, 10010, USA. rdabash@gynuity.org.
authors.forename: Rasha
authors.initials: R
authors.lastname: Dabash
authors.affiliation: Gynuity Health Projects, 15 East 26th Street, Suite 801, New York, NY, 10010, USA.
authors.forename: Tara
authors.initials: T
authors.lastname: Shochet
authors.affiliation: Groupe Tawhida Ben Cheikh, Tunis, Tunisia.
authors.forename: Selma
authors.initials: S
authors.lastname: Hajri
authors.affiliation: Clinique du Parc, Tunis, Tunisia.
authors.forename: Héla
authors.initials: H
authors.lastname: Chelli
authors.affiliation: Office National de la Famille et de la Population, Tunis, Tunisia.
authors.forename: Anne-Emmanuele
authors.initials: AE
authors.lastname: Hassairi
authors.affiliation: Nabeul CREPF-ONFP, Nabeul, Tunisia.
authors.forename: Douha
authors.initials: D
authors.lastname: Haleb
authors.affiliation: Office National de la Famille et de la Population, Tunis, Tunisia.
authors.forename: Hayet
authors.initials: H
authors.lastname: Labassi
authors.affiliation: Centre de Maternite et de Neonatologie de La Rabta, Tunis, Tunisia.
authors.forename: Ezzedine
authors.initials: E
authors.lastname: Sfar
authors.affiliation: Office National de la Famille et de la Population, Tunis, Tunisia.
authors.forename: Fatma
authors.initials: F
authors.lastname: Temimi
authors.affiliation: Gynuity Health Projects, 15 East 26th Street, Suite 801, New York, NY, 10010, USA.
authors.forename: Leah
authors.initials: L
authors.lastname: Koenig
authors.affiliation: Gynuity Health Projects, 15 East 26th Street, Suite 801, New York, NY, 10010, USA.
authors.forename: Beverly
authors.initials: B
authors.lastname: Winikoff
mesh_terms: D000028:Abortion, Induced; D000293:Adolescent; D000328:Adult; D000359:Aftercare / Q000379:methods*; D005260:Female; D005865:Gestational Age; D006266:Health Education / Q000379:methods / Q000592:standards; D006801:Humans; D008875:Middle Aged; D015735:Mifepristone / Q000494:pharmacology / Q000627:therapeutic use; D016595:Misoprostol / Q000494:pharmacology / Q000627:therapeutic use; D011247:Pregnancy; D011258:Pregnancy Tests / Q000379:methods* / Q000592:standards*; D011446:Prospective Studies; D012646:Self Administration / Q000379:methods / Q000592:standards; D014416:Tunisia
chemical_list: D016595:Misoprostol; D015735:Mifepristone
keywords: Medical abortion; Multi-level pregnancy test; Semi-quantitative pregnancy test; Tunisia