Study on Medical Records of Women Using a Coil (Intrauterine Device = IUD) for Birth Control to Analyze the Risk That a Coil Will Slip Out or Perforate the Womb in Relation to Breastfeeding, to the Point in Time When the Coil Was Inserted After Childbirth and in Relation to Different Types of Coils.
Status: | Active, not recruiting |
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Conditions: | Women's Studies |
Therapuetic Areas: | Reproductive |
Healthy: | No |
Age Range: | Any - 50 |
Updated: | 4/6/2019 |
Start Date: | December 3, 2018 |
End Date: | March 30, 2020 |
Study on the Association of Uterine Perforation and Intrauterine Device (IUD) Expulsion With Breastfeeding Status at the Time of IUD Insertion and Postpartum Timing of IUD Insertion in Electronic Medical Record Databases - A Postmarketing Requirement for Mirena
Study to analyze electronic medical records of women using a coil (intrauterine device = IUD
) for birth control. Study is required by the FDA for the marketed coil product Mirena (US
Post marketing requirement study, short name of study: APEX IUD).
Study will analyze the risk that a coil will slip out or perforate the womb for the following
comparisons:
- Comparing the risk for women who are breastfeeding at the time of coil insertion to the
risk for women who are not breastfeeding at the time of coil insertion.
- Comparing the risk for women who had a first coil insertion within different time
periods after childbirth (i.e., ≤ 6 weeks, > 6 weeks and ≤ 14 weeks, > 14 weeks and ≤ 52
weeks) to the risk for women who had their first coil insertion more than 52 weeks after
childbirth, including women without a childbirth within the past 52 weeks.
Study will also analyze the risk that a coil will slip out or perforate the womb for
different types of coils used. In addition the study aims to assess the following:
- The extent to which the type of coil (coils releasing the hormone LNG compared to copper
coils) will modify the risk that a coil will slip out or perforate the womb in relation
to breastfeeding and/ or in relation to the point in time when the coil was inserted
after childbirth.
- The extent to which the breastfeeding status will modify the risk that a coil will slip
out or perforate the womb in relation to the point in time when the coil was inserted
after childbirth.
) for birth control. Study is required by the FDA for the marketed coil product Mirena (US
Post marketing requirement study, short name of study: APEX IUD).
Study will analyze the risk that a coil will slip out or perforate the womb for the following
comparisons:
- Comparing the risk for women who are breastfeeding at the time of coil insertion to the
risk for women who are not breastfeeding at the time of coil insertion.
- Comparing the risk for women who had a first coil insertion within different time
periods after childbirth (i.e., ≤ 6 weeks, > 6 weeks and ≤ 14 weeks, > 14 weeks and ≤ 52
weeks) to the risk for women who had their first coil insertion more than 52 weeks after
childbirth, including women without a childbirth within the past 52 weeks.
Study will also analyze the risk that a coil will slip out or perforate the womb for
different types of coils used. In addition the study aims to assess the following:
- The extent to which the type of coil (coils releasing the hormone LNG compared to copper
coils) will modify the risk that a coil will slip out or perforate the womb in relation
to breastfeeding and/ or in relation to the point in time when the coil was inserted
after childbirth.
- The extent to which the breastfeeding status will modify the risk that a coil will slip
out or perforate the womb in relation to the point in time when the coil was inserted
after childbirth.
Inclusion Criteria:
- 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 Criteria:
- Women with more than 50 years of age at the time of the IUD-insertion
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