Bleeding Pattern Difference Between Levonorgestrel Intrauterine System (LNG-IUS) and Copper Intrauterine Devices (IUDs) Immediately Inserted After Abortion

Study Overview
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Brief Summary
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To observe the bleeding patterns of post-abortion immediate insertion of IUS compared to Cu-IUD over the first 6 months.

Official Title
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A Non-interventional Study to Observe the Bleeding Pattern of LNG-IUS Inserted Immediately After Surgical Abortion Compared With Copper IUD

Conditions
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Contraception

Intervention / Treatment
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* Drug: Levonorgestrel IUS (Mirena, BAY86-5028)
* Device: Copper-IUD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Reproductive women in good general health and requesting long-term contraception Applied the Cu-IUD or LNG-IUS immediately after first trimester surgical abortion History of regular cyclic menstrual periods Written ICF was obtained Exclusion Criteria: Suspected septic abortion and incomplete abortion, as well as missed abortion The contraindications and warnings of the respective Summary of Product Characteristics of Mirena or prescribing information of Cu-IUDs must be followed

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>The MIRENA intrauterine delivery system (initial release rate: 20 μg LNG /24 h) | Drug: Levonorgestrel IUS (Mirena, BAY86-5028)<br>* LNG-IUS once inserted will be effective for 5 years.<br>* Other names: Mirena Group;|
| Group 2<br>Copper IUDs with different shape and with or without drugs | Device: Copper-IUD<br>* Copper-IUD once inserted will be effective for more than 10 years.<br>* Other names: Cu-IUD Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of bleeding/spotting days assessed over the second 90-day reference period after induced abortion | The 90-day reference period is recommended by the WHO. Day 1 is defined as the insertion day. | Months 4 to 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menstrual bleeding intensity | It will be captured by patient dairy and measured by subjective scale as below. No bleeding Light bleeding Normal bleeding Heavy bleeding Very heavy bleeding | up to 6 months | 
| Abortion related bleeding days |  | up to 1 month | 
| Time to the first menstrual bleeding following abortion | This data will be calculated by days | up to 2 months | 
| Participants continuation rates of Mirena and Cu-IUD |  | up to 6 months | 
| Reasons for discontinuation of Mirena and Cu-IUD | It will be calculated by percentage | Up to 6 months | 
| Participants satisfaction rates of Mirena and Cu-IUD | It will be captured by satisfaction scale as below. Very satisfied Rather satisfied neither satisfied nor dissatisfied Rather unsatisfied Very unsatisfied | Up to 6 months | 
| Percentage of participants with adverse events | Adverse events included: Pelvic inflammatory disease, Expulsion and Others.) | Up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bleeding pattern, LNG-IUS, Cu-IUD, postabortion