Better Contraceptive Choices: Insertion timing and effectiveness of intrauterine and other contraceptive methods post-abortion
Main research objectives:
1) Will immediate insertion of an IUC following a second trimester abortion result in fewer pregnancies than the current recommended care of intended placement at 4 weeks post abortion?
H: Intrauterine contraception placed immediately after a second trimester abortion will result in fewer pregnancies than current standard practice of intended placement at 4 weeks post-abortion.
2) Is the effectiveness of the FlexiT copper IUC comparable with the most common Canadian copper IUC currently in use, the NovaT, when placed immediately after first trimester abortion?
H: The FlexiT will be comparably as effective and as safe when compared with the NovaT following first trimester abortion.
The following research questions will also be answered:
3) Is there a difference in expulsion rates between IUCs inserted immediately following second trimester abortion and those inserted at 4 or more weeks post abortion? or between those of the FlexiT and the NovaT?
H: There will be no significant difference in expulsion rates across any groups under study.
4) What is the rate of continuation of use of each IUC contraception method, and how does this relate to rates of continuation for non-IUC methods (e.g. hormonal contraception)?
H: Rates of continuation will be higher for LNG-IUC than Copper IUC, rates of continuation of both copper IUC will be comparable, rates of continuation for all IUC will be higher than continuation for all non-IUC methods, and pregnancies among all IUC users will be fewer than among all enrolled participants where an IUC was not placed including among those choosing non-IUC contraceptive methods.
5) What are the rates of adverse events (e.g. infection or perforation) following post-abortion of insertion of IUC? Does this vary between types of IUC? Is this different among women where an IUC was placed and among enrolled participants where an IUC was not placed (including adverse events related to future unintended pregnancies such as perinatal morbidity and mortality)? What are the health system costs related to these events?
H: Rates and severity of adverse events and subsequent health system costs relating to all study participants will be comparable, independent of type of contraception intended or utilized, excepting that participants not utilizing IUC will experience a higher rate of pregnancy, pregnancy-related complications, perinatal morbidity and mortality, and pregnancy-related costs.
6) Do the outcomes differ among participants who were chlamydia-positive or gonorrhea-positive at the time of abortion, and among positive participants between those with IUC placement at the time of the procedure or those who did not have an IUC placed or chose another method of contraception?
H: Placement of IUC at the time of abortion among women where test results subsequently indicate the presence of chlamydia or gonorrhea at the time of placement will have identical outcomes, complications and costs to those women chlamydia and gonorrhea positive who did not have an IUC placed, except among the latter group higher pregnancy related costs within the subsequent year will be evident.
7) Are study participants satisfied with their contraception method (data from contraception satisfaction questionnaires, clinic charts and follow up visits)?
H: Study participants will express higher satisfaction when an IUC is placed at the time of abortion than among participants choosing any other contraception method, or among those for whom an IUC was not placed. Participants with an LNG-IUC will have higher satisifaction than those with a copper-IUC.
8) Is one method, or one time of insertion, more cost effective than another from the perspective of the patient, or the perspective of the health system?
H: Cost-effectiveness of immediate placement of any IUC at the time of an abortion will be higher than cost-effectiveness among women choosing any other method, and among those intending placement of the IUC at a later time. Cost-effectiveness of the FlexiT will be higher than that of the NovaT copper IUC.
9) Are there differences in subsequent contraceptive method use, in duration of use of an IUC or non-IUC method, in inter-pregnancy intervals, in health system costs, or in complications or outcomes related to subsequent fertility events related to IUC method timing, type of IUC or other contraceptive method chosen post abortion?
H: Women having IUC placed at the time of a first or second trimester abortion will have longer retention of the chosen contraceptive method, be less likely to change contraceptive method within the first year, have longer inter-pregnancy intervals and lower health system costs, fewer complications and better outcomes related to subsequent fertility events than women choosing any alternate method of contraception, or among those intending to have IUC placed at a later time.
10) How are demographic and socioeconomic variables related to contraceptive use, complications, and pregnancy outcomes among enrolled participants in these trials?
H: Women in marginalized and vulnerable groups will demonstrate the highest rates of improved outcomes with IUC use compared to intention to use IUC or to use other contraceptives or no contraception. Pregnancy outcomes and health system costs will vary based upon age, urban vs rural status, education, economic classification (via reported income or postal code surrogate), reported ethnicity, parity, and concomitant medical conditions.
11) How does data capture for health system events for enrolled participants in the health system databases relate to clinical events documented in clinic patient records or enrollment or follow up encounters within this study protocol?
H: Placement of IUC, documentation of primary and subsequent pregnancy outcomes and other health system events, will be identical between the health administrative databases and the clinic and study protocol encounter documented events.