Levonorgestrel for Post-medical abortion contraception

Inclusion criteria

• {"criterion_text":"- above 18 years old\n- eligible for medical abortion\n- opting for post abortion Intrauterine contraception\n- able and willing to comply with planned follow up"}

Exclusion criteria

• {"criterion_text":"- contraindication for medical abortion\n- contraindication for intrauterine contraception (contraindications may be present for LNG- IUSs but the woman may still choose a Cu-IUD and thereby enter the study),\n- inability to give informed consent.\n- Septic abortion"}

Primary endpoints

• {"endpoint_text":"- The proportion of women in each group (immediate or delayed) using intrauterine contraception as contraception at 6 months post abortion","definition_or_measurement_approach":"Proportion of women in each group using intrauterine contraception at 6 months post abortion (measured as use of IUC at 6 months post abortion)."}

Secondary endpoints

• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Measured by telephone or e-mail follow-up at 3, 6 and 12 months; continued use, voluntary/involuntary discontinuation, reasons and subsequent contraceptive use recorded."}
• {"endpoint_text":"- Difference in the proportion of women who successfully have the IUC inserted (success versus failure),","definition_or_measurement_approach":"Proportion of successful versus failed insertions recorded."}
• {"endpoint_text":"- Ease of insertion according to health care provider (judged as very easy, easy, moderately, or very difficult)","definition_or_measurement_approach":"Provider-judged ease of insertion categorized as very easy, easy, moderately, or very difficult."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Pain measured using a 10 cm Visual Analogue Scale (VAS); marks converted to millimetres and entered into case report forms."}
• {"endpoint_text":"- Post-abortion bleeding (number of days of fresh bleeding and spotting after the abortion)","definition_or_measurement_approach":"Number of days of fresh bleeding and spotting recorded post-abortion."}
• {"endpoint_text":"- Reasons for non-attempted insertion of IUC (change of mind, heavy bleeding, not coming for insertion, staff being unavailable etc),","definition_or_measurement_approach":"Reasons for non-attempted insertion documented (e.g., change of mind, heavy bleeding, no show, staff unavailable)."}
• {"endpoint_text":"- Pregnancies occurring during the 6 and 12 month follow-up (planned and unplanned, wanted and unwanted, pregnancy outcomes- ectopic, miscarriage, abortion, molar, kept pregnancy),","definition_or_measurement_approach":"Pregnancies during 6 and 12 month follow-up recorded with outcomes (ectopic, miscarriage, abortion, molar, continued pregnancy)."}
• {"endpoint_text":"- 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),","definition_or_measurement_approach":"Acceptability assessed by asking participants yes/no if they would recommend the procedure at insertion and at 3- and 6-month follow-ups."}
• {"endpoint_text":"- Acceptability of IUC as post abortion contraception- evaluated as above,","definition_or_measurement_approach":"Acceptability of IUC as post-abortion contraception evaluated similarly (participant responses recorded)."}
• {"endpoint_text":"- 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),","definition_or_measurement_approach":"Expulsion rate assessed by telephone follow-up at 3, 6 and 12 months; complete/partial/no expulsion recorded and exact day of expulsion noted."}
• {"endpoint_text":"- Complications (adverse events (AE) and serious AE) bleeding requiring any treatment, uterine perforations and cervical tears, infection requiring treatment with antibiotics, hospitalization for any reason, surgical procedures due to heavy bleeding, incomplete abortions, prolonged bleeding or patient request,","definition_or_measurement_approach":"Complications and adverse events (including bleeding requiring treatment, perforations, tears, infections requiring antibiotics, hospitalizations, surgical procedures) recorded."}
• {"endpoint_text":"- The proportion of surgical procedures in total and for each study site (type of procedure, reasons therefore- infection, retained products of conception, prolonged bleeding etc).","definition_or_measurement_approach":"Proportion and type of surgical procedures recorded overall and by site, with reasons (infection, retained products, prolonged bleeding, etc.)."}

Sweden

Earliest CTIS Part Ii Submission Date

28-09-2024

Latest Decision Or Authorization Date

09-10-2024

Processing Time Days

11

Number Of Sites

7

Number Of Participants

720

Primary sponsor

Full Name

Karolinska Institutet

Organisation Type

Educational Institution

Country Of Registered Address

Sweden