Status:
COMPLETED
Study on Medical Records of Women Using an Intrauterine Device (IUD) to Analyze the Risks That the IUD Will be Expelled or Perforates the Womb in Relation to Breastfeeding, the Point in Time When the IUD Was Inserted After Childbirth and in Relation to Different Types of IUDs
Lead Sponsor:
Bayer
Conditions:
Intrauterine Devices
Eligibility:
FEMALE
Up to 50 years
Brief Summary
Study to analyze electronic medical records of women using an intrauterine device (IUD). The study was required by the FDA for the marketed IUD Mirena (US Post-marketing requirement; short name of stu...
Eligibility Criteria
Inclusion
- Women with evidence in the database of insertion of an IUD (e.g. levonorgestrel-releasing, copper) during the study time window for each site
- Enrolled in the database with electronic medical records available for review for at least 12 months before the IUD insertion
Exclusion
- \- Women with more than 50 years of age at the time of the IUD-insertion
Key Trial Info
Start Date :
December 3 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 29 2019
Estimated Enrollment :
326658 Patients enrolled
Trial Details
Trial ID
NCT03754556
Start Date
December 3 2018
End Date
November 29 2019
Last Update
December 4 2020
Active Locations (4)
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1
Kaiser Permanente Northern California
Oakland, California, United States, 94612
2
Kaiser Permanente Southern California
Pasadena, California, United States, 91101
3
Regenstrief Institute
Indianapolis, Indiana, United States, 46202
4
Kaiser Permanente Washington
Seattle, Washington, United States, 98101