Bleeding pattern difference between levonorgestrel intrauterine system and copper intrauterine devices inserted immediately post-abortion: a multicenter, prospective, observational cohort study in Chinese women

Abstract

Background: To describe the bleeding pattern (primary outcome), side effects, treatment satisfaction and 6 month continuity rates associated with the 52 mg levonorgestrel intrauterine system (LNG-IUS) and the copper intrauterine device (Cu-IUD) inserted immediately after abortion.

Methods: This multicenter, prospective, observational cohort study enrolled healthy women (aged ≥18 years) inserted with LNG-IUS or Cu-IUD immediately after first-trimester surgical abortion and followed up to 6 months. Bleeding pattern was obtained through daily patient bleeding diaries.

Results: From 2013 to 2014, we enrolled 512 women (LNG-IUS = 312 [median age: 32.0 years] and Cu-IUD = 200 [median age: 30.0 years]) from nine Chinese centers. LNG-IUS resulted in a significantly lower number of bleeding/spotting days in the second 90 day reference period compared with Cu-IUD (median 14.5 vs. 18.0 days, p < .0001). Amenorrhea rate (no bleeding/spotting day in the second 90 day reference period) and no menstrual bleeding rate (absence of bleeding days in the second 90 day reference period) were significantly higher in LNG-IUS compared to Cu-IUD (13.9% vs. 0% and 39.5% vs. 0%; p < .001 for all). No dysmenorrhea was higher at the last follow-up in LNG-IUS users than Cu-IUD users (81.2% vs. 76%; p = .0047). Both treatments had a high satisfaction rate among women at both the follow-up visits, and the majority of them continued with the treatment. The rates of adverse events (e.g. oligomenorrhea, amenorrhea) in the LNG-IUS and Cu-IUD groups were 77.2% and 44.5% (p < .0001), respectively.

Conclusion: LNG-IUS post-abortion shows better bleeding patterns, and reduced dysmenorrhea and bleeding amount, but with a similar safety profile compared with Cu-IUD.

ClinicalTrials.gov identifier: NCT01958684

Keywords:

• Levonorgestrel-releasing intrauterine system
• bleeding patterns
• dysmenorrhea severity
• satisfaction

Notes

Transparency

Declaration of funding

This study was funded by Bayer China.

Author contributions: All authors substantially contributed to the study. X.C., Q.L. and X.W. conceptualized and designed the study protocol. J.C., W.L., B.S. and H.W. conducted the study and obtained and analyzed the results. J.L. and J.Li interpreted the results and developed the manuscript. All authors approved the final draft for publication.

Declaration of financial/other relationships

X.C., Q.L., X.W., J.C., W.L., B.S., H.W., J.L. and J.Li have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgements

The authors thank Mr. Karan Sharma, Dr. Amit Bhat and Dr. Anuradha Nalli (Indegene, Bangalore, India) for providing medical writing support and technical assistance in the development of this manuscript, funded by Bayer China.

Notes

1 Mirena is a registered trade name of Bayer Schering Pharma Oy, Espoo, Finland

2 GyneFix is a registered trade name of Contrel Research, Belgium

3 Multiload-Cu 375 is a registered trade name of Pregna International Ltd, India

4 Flexi-T is a trade name of Prosan International BV, Arnhem, The Netherlands