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

NCT01958684 | Completed

• 2 other identifiers: 16954MA1310CN
• Study Type: observational
• Target: 512
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Contraception

Keywords

Bleeding pattern; LNG-IUS; Cu-IUD; postabortion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Menstrual bleeding intensity

  up to 6 months

• Abortion related bleeding days

  up to 1 month

• Time to the first menstrual bleeding following abortion

  up to 2 months

• Participants continuation rates of Mirena and Cu-IUD

  up to 6 months

• Reasons for discontinuation of Mirena and Cu-IUD

  Up to 6 months

Study Arms (2)

Group 1

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

Drug: Levonorgestrel IUS (Mirena, BAY86-5028)

Group 2

Copper IUDs with different shape and with or without drugs

Device: Copper-IUD

Interventions

Levonorgestrel IUS (Mirena, BAY86-5028) DRUG

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

Also known as: Mirena Group

Group 1

Copper-IUD DEVICE

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

Also known as: Cu-IUD Group

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All subjects should go through the surgical abortion should meet both inclusion and exclusion criteria. And they are willing to sign an informed consent. And all recruitment should be conducted after the decision of treatment.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, China

Location

Related Publications (1)

• Chen X, Li Q, Wang X, Chen J, Lv W, Shi B, Wang H, Luo J, Li J. Bleeding pattern difference between levonorgestrel intrauterine system and copper intrauterine devices inserted immediately post-abortion: a multicenter, prospective, observational cohort study in Chinese women. Curr Med Res Opin. 2018 May;34(5):873-880. doi: 10.1080/03007995.2017.1421919. Epub 2018 Feb 7.

  PMID: 29298525 DERIVED

MeSH Terms

Interventions

Levonorgestrel; Intrauterine Devices, Copper

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Intrauterine Devices, Medicated; Intrauterine Devices; Contraceptive Devices, Female; Contraceptive Devices; Equipment and Supplies

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: October 9, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 16, 2015

Record last verified: 2015-10

Locations

CN (1)