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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

512 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-10-31

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.

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Detailed Description

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Conditions

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Contraception

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

The MIRENA intrauterine delivery system (initial release rate: 20 μg LNG /24 h)

Levonorgestrel IUS (Mirena, BAY86-5028)

Intervention Type DRUG

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

Group 2

Copper IUDs with different shape and with or without drugs

Copper-IUD

Intervention Type DEVICE

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

Interventions

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Levonorgestrel IUS (Mirena, BAY86-5028)

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

Intervention Type DRUG

Copper-IUD

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

Intervention Type DEVICE

Other Intervention Names

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Mirena Group Cu-IUD Group

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No