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
NCT ID: NCT03754556
Last Updated: 2020-12-04
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
326658 participants
OBSERVATIONAL
2018-12-03
2019-11-29
Brief Summary
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The study analyzed the risks that the IUD was expelled or perforated the womb for the following group comparisons:
* Women who were breastfeeding at the time of IUD insertion and within 52 weeks postpartum versus women who were not breastfeeding at the time of IUD insertion and within 52 weeks postpartum.
* Women who had a first observed IUD insertion within different time periods after childbirth (i.e., ≤ 6 weeks, \> 6 weeks and ≤ 14 weeks, \> 14 weeks and ≤ 52 weeks) versus women who had their first observed IUD insertion more than 52 weeks after childbirth, including women without a recorded delivery within the past 52 weeks. An additional analysis involved 5-level postpartum timing (i.e., 0 to 3 days, 4 days to ≤ 6 weeks, \> 6 weeks to ≤ 14 weeks, \> 14 weeks to ≤ 52 weeks) versus the \> 52 week postpartum group.
The study also analyzed the risks that the IUD was expelled or perforated the womb for different types of IUDs. In addition, the study aimed to assess the following interactions:
* The extent to which the type of IUD (IUDs releasing the hormone LNG versus Copper IUDs) modified the risk that an IUD was expelled or perforated the womb in relation to breastfeeding and/ or in relation to the point in time when the IUD was inserted after childbirth.
* The extent to which the breastfeeding status modified the risk that an IUD was expelled or perforated the womb in relation to the point in time when the IUD was inserted after childbirth.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Women with IUD
Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.
Intrauterine device
Intrauterine devices, e.g. BAY86-5028 (Mirena, Skyla, Kyleena), Liletta and ParaGard
Interventions
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Intrauterine device
Intrauterine devices, e.g. BAY86-5028 (Mirena, Skyla, Kyleena), Liletta and ParaGard
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Enrolled in the database with electronic medical records available for review for at least 12 months before the IUD insertion
Exclusion Criteria
50 Years
FEMALE
Yes
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Kaiser Permanente Northern California
Oakland, California, United States
Kaiser Permanente Southern California
Pasadena, California, United States
Regenstrief Institute
Indianapolis, Indiana, United States
Kaiser Permanente Washington
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Click here to find results for studies related to Bayer products
Other Identifiers
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19682
Identifier Type: -
Identifier Source: org_study_id