Post medical abortion contraception
Conditions
Interventions
Trade Name: Mirena
Product Name: Mirena
Pharmaceutical Form: Intrauterine delivery system
INN or Proposed INN: LEVONORGESTREL
Other descriptive name: Mirena
Concentration unit: U unit(s)
Concentration
Sponsors
Karolinska Institutet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Above 18 years old, • eligible for medical abortion, • opting for post abortion IUC, • able and willing to comply with planned follow up. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 720 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Contraindication for medical abortion or • Contraindication for IUC (contraindications may be present for LNG-IUSs but the woman may still choose a Cu-IUD and thereby enter the study), • inability to give informed consent. • Septic abortion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study if immediate insertion of intrauterine contraception (IUC) is superior to insertion at 2-4 weeks post abortion with regard to number of women using IUC as contraception at 6 months post abortion.;Secondary Objective: To study if immediate insertion of intrauterine contraception is non-inferior to delayed insertion with regard to safety and acceptability.;Primary end point(s): The proportion of women in each group (immediate or delayed) using intrauterine contraception as contraception at 6 months post abortion (use vs non-use).;Timepoint(s) of evaluation of this end point: 6 months post abortion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy, acceptability: • Use of IUC at 3, 6 and 12 months post insertion evaluated by telephone or e-mail follow-up (continued use/voluntary discontinued use, involuntary discontinued use including expulsions etc) reasons for discontinuation will be recorded and subsequent use of other contraceptive methods will be noted) • Difference in the proportion of women who successfully have the IUC inserted (success versus failure), • Ease of insertion according to health care provider (judged as very easy, easy, moderately, or very difficult) • pain at time of insertion (women will indicate the pain before insertion, at placement of tenaculum, sound and IUC by putting a vertical mark on a 10 cm long horizontal line with a Visual Analogue Scale (VAS) from 0, indicating no pain to 10 indicating worst imaginable pain. Result will be noted in millimeters and entered into case report forms). • Post-abortion bleeding (number of days of fresh bleeding and spotting after the abortion) • Reasons for non-attempted insertion of IUC (change of mind, heavy bleeding, not coming for insertion, staff being unavailable etc), • Pregnancies occurring during the 6 and 12 month follow-up (planned and unplanned, wanted and unwanted, pregnancy outcomes- ectopic, miscarriage, abortion, molar, kept pregnancy), • Acceptability of immediate and delayed insertion of IUC by asking women if they would recommend the procedure to a friend (yes/no, asked at the time of insertion and at the 3 and 6 month follow up), • Acceptability of IUC as post abortion contraception- evaluated as above, Safety: • Expulsion rate during 12 months following insertion in both groups evaluated by telephone follow up at 3, 6 and 12 months post abortion (complete, partial or no expulsion. The exact day of expulsion will be noted to determine the risk of expulsion as a function of time post insertion), • Complications (adverse events (AE) and serious AE) bleeding requiring any treatment, uter | — |
Countries
Sweden
Contacts
Public ContactHelena Kopp Kallner, PI
Karolinska Institutet
Outcome results
None listed