Contraception
Conditions
Keywords
Bleeding pattern, LNG-IUS, Cu-IUD, postabortion
Brief summary
To observe the bleeding patterns of post-abortion immediate insertion of IUS compared to Cu-IUD over the first 6 months.
Interventions
LNG-IUS once inserted will be effective for 5 years.
DEVICECopper-IUD
Copper-IUD once inserted will be effective for more than 10 years.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of bleeding/spotting days assessed over the second 90-day reference period after induced abortion | Months 4 to 6 | The 90-day reference period is recommended by the WHO. Day 1 is defined as the insertion day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abortion related bleeding days | up to 1 month | — |
| Time to the first menstrual bleeding following abortion | up to 2 months | This data will be calculated by days |
| Participants continuation rates of Mirena and Cu-IUD | up to 6 months | — |
| Menstrual bleeding intensity | up to 6 months | 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 |
| Participants satisfaction rates of Mirena and Cu-IUD | Up to 6 months | It will be captured by satisfaction scale as below. * Very satisfied * Rather satisfied * neither satisfied nor dissatisfied * Rather unsatisfied * Very unsatisfied |
| Percentage of participants with adverse events | Up to 6 months | Adverse events included: Pelvic inflammatory disease, Expulsion and Others.) |
| Reasons for discontinuation of Mirena and Cu-IUD | Up to 6 months | It will be calculated by percentage |
Countries
China
Outcome results
None listed