Clinical trial NCT03754556: 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
Official title: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intrauterine Devices
Keywords: Contraception
Breast-feeding
Electronic medical records
Uterine perforation
Expulsion of intrauterine device
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-11-27
Enrollment: 326658
Sex: FEMALE
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with IUD-insertion

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 study: APEX IUD).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Crude Incidence Rate of Uterine Perforation Stratified by Breastfeeding Status Among Women Within 52 Weeks Postpartum-first Observed IUD Insertions
timeFrame: Up to 11 years
measure: Cumulative Incidence of Uterine Perforation Stratified by Breastfeeding Status Among Women Within 52 Weeks Postpartum-first Observed IUD Insertions
timeFrame: At 1 year and 5 years of follow-up
measure: Adjusted Hazard Ratio (HR) for Breastfeeding Status and Uterine Perforation-first Observed IUD Insertions
timeFrame: Up to 11 years
measure: Crude Incidence Rate of Uterine Perforation Categorized by Postpartum Timing-first Observed IUD Insertions
timeFrame: Up to 11 years
measure: Cumulative Incidence of Uterine Perforation Categorized by Postpartum Timing-first Observed IUD Insertions
timeFrame: At 1 year and 5 years of follow-up
measure: Adjusted Hazard Ratio (HR) for Postpartum Timing and Uterine Perforation-first Observed IUD Insertions
timeFrame: Up to 11 years
measure: Adjusted Hazard Ratio (HR) for Postpartum Timing Risk 14-week Cut Point and Uterine Perforation-first Observed IUD Insertions
timeFrame: Up to 11 years
measure: Adjusted Hazard Ratio (HR) for Postpartum Timing Risk 36-week Cut Point and Uterine Perforation-first Observed IUD Insertions
timeFrame: Up to 11 years
measure: Adjusted Incidence Rate Ratio (IRR) for Uterine Perforation-first Observed IUD Insertions
timeFrame: At 1 year and 5 years of follow-up
measure: Adjusted Incidence Rate Difference (IRD) for Uterine Perforation-first Observed IUD Insertions
timeFrame: At 1 year and 5 years of follow-up
measure: Crude Incidence Rate of Uterine Perforation Stratified by IUD Type-first Observed IUD Insertions
timeFrame: Up to 11 years
measure: Cumulative Incidence of Uterine Perforation Stratified by IUD Type-first Observed IUD Insertions
timeFrame: At 1 year and 5 years of follow-up
measure: Adjusted Hazard Ratio (HR) for IUD Type and Uterine Perforation-first Observed IUD Insertions
timeFrame: Up to 11 years
measure: Crude Incidence Rate of Uterine Perforation Stratified by Menorrhagia Status-first Observed IUD Insertions
timeFrame: Up to 11 years
measure: Cumulative Incidence of Uterine Perforation Stratified by Menorrhagia Status-first Observed IUD Insertions
timeFrame: At 1 year and 5 years of follow-up
measure: Adjusted Hazard Ratio (HR) for Menorrhagia Status and Uterine Perforation-first Observed IUD Insertions
timeFrame: Up to 11 years
measure: Effect Modification of Breastfeeding Status on Postpartum Timing for Uterine Perforation
timeFrame: Up to 11 years
measure: Effect Modification of IUD Type on Breastfeeding Status for Uterine Perforation
timeFrame: Up to 11 years
measure: Effect Modification of IUD Type on Postpartum Timing for Uterine Perforation
timeFrame: Up to 11 years
Secondary outcomes:
measure: Crude Incidence Rate of IUD Expulsion Stratified by Breastfeeding Status Among Women Within 52 Weeks Postpartum-first Observed IUD Insertions
timeFrame: Up to 11 years
measure: Cumulative Incidence of IUD Expulsion Stratified by Breastfeeding Status Among Women Within 52 Weeks Postpartum-first Observed IUD Insertions
timeFrame: At 1 year and 5 years of follow-up
measure: Adjusted Hazard Ratio (HR) for Breastfeeding Status and IUD Expulsion-first Observed IUD Insertions
timeFrame: Up to 11 years
measure: Crude Incidence Rate of IUD Expulsion Categorized by Postpartum Timing-first Observed IUD Insertions
timeFrame: Up to 11 years
measure: Cumulative Incidence of IUD Expulsion Categorized by Postpartum Timing-first Observed IUD Insertions
timeFrame: At 1 year and 5 years of follow-up
measure: Adjusted Hazard Ratio (HR) for Postpartum Timing and IUD Expulsion-first Observed IUD Insertions
timeFrame: Up to 11 years
measure: Adjusted Hazard Ratio (HR) for Postpartum Timing Risk 14-week Cut Point and IUD Expulsion-first Observed IUD Insertions
timeFrame: Up to 11 years
measure: Adjusted Hazard Ratio (HR) for Postpartum Timing Risk 36-week Cut Point and IUD Expulsion-first Observed IUD Insertions
timeFrame: Up to 11 years
measure: Adjusted Incidence Rate Ratio (IRR) for IUD Expulsion-first Observed IUD Insertions
timeFrame: At 1 year and 5 years of follow-up
measure: Adjusted Incidence Rate Difference (IRD) for IUD Expulsion-first Observed IUD Insertions
timeFrame: At 1 year and 5 years of follow-up
measure: Crude Incidence Rate of IUD Expulsion Stratified by IUD Type-first Observed IUD Insertions
timeFrame: Up to 11 years
measure: Cumulative Incidence of IUD Expulsion Stratified by IUD Type-first Observed IUD Insertions
timeFrame: At 1 year and 5 years of follow-up
measure: Adjusted Hazard Ratio (HR) for IUD Type and IUD Expulsion-first Observed IUD Insertions
timeFrame: Up to 11 years
measure: Crude Incidence Rate of IUD Expulsion Stratified by Menorrhagia Status-first Observed IUD Insertions
timeFrame: Up to 11 years
measure: Cumulative Incidence of IUD Expulsion Stratified by Menorrhagia Status-first Observed IUD Insertions
timeFrame: At 1 year and 5 years of follow-up
measure: Adjusted Hazard Ratio (HR) for Menorrhagia Status and IUD Expulsion-first Observed IUD Insertions
timeFrame: Up to 11 years
measure: Effect Modification of IUD Type on Breastfeeding Status for IUD Expulsion
timeFrame: Up to 11 years
measure: Effect Modification of IUD Type on Postpartum Timing for IUD Expulsion
timeFrame: Up to 11 years
measure: Number of Indicators of a Potentially Difficult Insertion, Overall, by Breastfeeding Status, and by Postpartum Timing of IUD Insertion-first Observed IUD Insertions
timeFrame: Up to 11 years
measure: Number of Indicators of a Potentially Difficult Insertion, Overall, by IUD Type and by Menorrhagia Status-first Observed IUD Insertions
timeFrame: Up to 11 years
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Northern California
state: California
city: Pasadena
country: United States
facility: Kaiser Permanente Southern California
state: California
city: Indianapolis
country: United States
facility: Regenstrief Institute
state: Indiana
city: Seattle
country: United States
facility: Kaiser Permanente Washington
state: Washington
Study officials:
References: