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

N/ACompletedNCT01958684

Bayer512 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

512

Conditions

Contraception

Interventions

Levonorgestrel IUS (Mirena, BAY86-5028)DRUG

LNG-IUS once inserted will be effective for 5 years.

Copper-IUDDEVICE

Copper-IUD once inserted will be effective for more than 10 years.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Many Locations, China

Outcomes

Primary Outcomes

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.

Time frame: Months 4 to 6

Secondary Outcomes

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

Time frame: up to 6 months

Abortion related bleeding days

Time frame: up to 1 month

Time to the first menstrual bleeding following abortion

This data will be calculated by days

Time frame: up to 2 months

Participants continuation rates of Mirena and Cu-IUD

Time frame: up to 6 months

Reasons for discontinuation of Mirena and Cu-IUD

It will be calculated by percentage

Time frame: 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

Time frame: Up to 6 months

Percentage of participants with adverse events

Adverse events included: Pelvic inflammatory disease, Expulsion and Others.)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.