title: Immediate vs. delayed insertion of intrauterine contraception after second trimester abortion: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  We describe the rationale and protocol for a randomized controlled trial (RCT) to assess whether intrauterine contraception placed immediately after a second trimester abortion will result in fewer pregnancies than current recommended practice of intended placement at 4 weeks post-abortion. Decision analysis suggests the novel strategy could substantially reduce subsequent unintended pregnancies and abortions. This paper highlights considerations of design, implementation and evaluation of a trial expected to provide rigorous evidence for appropriate insertion timing and health economics of intrauterine contraception after second trimester abortion.
  
  
  METHODS
  Consenting women choosing to use intrauterine contraception after abortion for a pregnancy of 12 to 24 weeks will be randomized to insertion timing groups either immediately (experimental intervention) or four weeks (recommended care) post abortion. Primary outcome measure is pregnancy rate at one year. Secondary outcomes include: cumulative pregnancy rates over five year follow-up period, comprehensive health economic analyses comparing immediate and delayed insertion groups, and device retention rates, complication rates (infection, expulsion) and, contraceptive method satisfaction. Web-based Contraception Satisfaction Questionnaires, clinical records and British Columbia linked health databases will be used to assess primary and secondary outcomes. Enrolment at all clinics in the province performing second trimester abortions began in May 2010 and is expected to complete in late 2011. Data on one year outcomes will be available for analysis in 2014.
  
  
  CONCLUSIONS
  The RCT design combined with access to clinical records at all provincial abortion clinics, and to information in provincial single-payer linked administrative health databases, birth registry and hospital records, offers a unique opportunity to evaluate such an approach by determining pregnancy rate at one through five years among enrolled women. We highlight considerations of design, implementation and evaluation of a trial expected to provide rigorous evidence for appropriate insertion timing and health economics of intrauterine contraception after second trimester abortion.
authors.affiliation: Contraception & Abortion Research Team, Women's Health Research Institute, Vancouver, British Columbia, V6H 1G3, Canada. wvnorman@interchange.ubc.ca
authors.forename: Wendy V
authors.initials: WV
authors.lastname: Norman
authors.forename: Janusz
authors.initials: J
authors.lastname: Kaczorowski
authors.forename: Judith A
authors.initials: JA
authors.lastname: Soon
authors.forename: Rollin
authors.initials: R
authors.lastname: Brant
authors.forename: Stirling
authors.initials: S
authors.lastname: Bryan
authors.forename: Konia J
authors.initials: KJ
authors.lastname: Trouton
authors.forename: Lyda
authors.initials: L
authors.lastname: Dicus
mesh_terms: D000028:Abortion, Induced; D001955:British Columbia; D003267:Contraception / Q000009:adverse effects / Q000191:economics / Q000295:instrumentation*; D003362:Cost-Benefit Analysis; D005260:Female; D017048:Health Care Costs; D006801:Humans; D007434:Intrauterine Devices / Q000009:adverse effects / Q000191:economics; D017060:Patient Satisfaction; D011247:Pregnancy; D018873:Pregnancy Rate; D011262:Pregnancy Trimester, Second; D049168:Pregnancy, Unplanned; D011275:Pregnancy, Unwanted; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors