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

NCT03754556 | Completed Results

• 1 other identifier: 19682
• Study Type: observational
• Target: 326,658
• Locations: 1 country
• Sites: 4

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.

Conditions

Intrauterine Devices

Keywords

Contraception; Breast-feeding; Electronic medical records; Uterine perforation; Expulsion of intrauterine device

Outcome Measures

Primary Outcomes (19)

• Crude Incidence Rate of Uterine Perforation Stratified by Breastfeeding Status Among Women Within 52 Weeks Postpartum-first Observed IUD Insertions

  Crude incidence rate was calculated as the number of outcomes occurring during the person-time at risk divided by the total person-time at risk (in person-years)

  Up to 11 years

• Cumulative Incidence of Uterine Perforation Stratified by Breastfeeding Status Among Women Within 52 Weeks Postpartum-first Observed IUD Insertions

  Crude estimates of the cumulative incidence, defined as number of outcomes occurring up to a time point out of the number of IUD insertions

  At 1 year and 5 years of follow-up

• Adjusted Hazard Ratio (HR) for Breastfeeding Status and Uterine Perforation-first Observed IUD Insertions

  Propensity score-adjusted hazard ratio to evaluate whether the risk of uterine perforation among women who were breastfeeding at the time of first observed IUD insertion differs from the risk of uterine perforation among women who were not breastfeeding at the time of first observed IUD insertion

  Up to 11 years

• Crude Incidence Rate of Uterine Perforation Categorized by Postpartum Timing-first Observed IUD Insertions

  Crude incidence rate was calculated as the number of outcomes occurring during the person-time at risk divided by the total person-time at risk (in person-years)

  Up to 11 years

• Cumulative Incidence of Uterine Perforation Categorized by Postpartum Timing-first Observed IUD Insertions

  Crude estimates of the cumulative incidence, defined as number of outcomes occurring up to a time point out of the number of IUD insertions

  At 1 year and 5 years of follow-up

• Adjusted Hazard Ratio (HR) for Postpartum Timing and Uterine Perforation-first Observed IUD Insertions

  Adjusted for propensity scores and breastfeeding status, to evaluate whether the risk of uterine perforation among women who had a first observed IUD insertion within different time periods postpartum differs from the risk of uterine perforation among women who had their first observed IUD insertion more than 52 weeks postpartum, including women without a recorded delivery within the past 52 weeks. Reference group: IUD insertion \> 52 weeks postpartum

  Up to 11 years

• Adjusted Hazard Ratio (HR) for Postpartum Timing Risk 14-week Cut Point and Uterine Perforation-first Observed IUD Insertions

  Adjusted for propensity scores and breastfeeding status, to estimate the risk of uterine perforation among women who had a first observed IUD insertion early in the postpartum period (i.e., up to 14 weeks postpartum) versus those who had a first observed IUD insertion late in the postpartum period (i.e., more than 14 weeks postpartum, including women without recorded delivery within the past 52 weeks). Reference group: IUD insertion \>14 weeks postpartum or with no recorded delivery

  Up to 11 years

• Adjusted Hazard Ratio (HR) for Postpartum Timing Risk 36-week Cut Point and Uterine Perforation-first Observed IUD Insertions

  Adjusted for propensity scores and breastfeeding status, to estimate the risk of uterine perforation among women who had a first observed IUD insertion ≤ 36 weeks postpartum versus women who had a first observed IUD insertion \> 36 weeks postpartum, including women without recorded delivery within the past 52 weeks. Reference group: IUD insertion \>36 weeks postpartum or with no recorded delivery

  Up to 11 years

• Adjusted Incidence Rate Ratio (IRR) for Uterine Perforation-first Observed IUD Insertions

  Adjusted for propensity score, overall and stratified by breastfeeding status at the time of IUD insertion for ≤ 36 weeks postpartum at IUD insertion versus \> 36 weeks postpartum or with no recorded delivery, at 1 year and 5 years of follow-up. Reference group: \> 36 weeks or no delivery

  At 1 year and 5 years of follow-up

• Adjusted Incidence Rate Difference (IRD) for Uterine Perforation-first Observed IUD Insertions

  Propensity score-adjusted incidence rate differences (per 1,000 person-years) for uterine perforation for women ≤ 36 weeks postpartum at IUD insertion compared with those who were \> 36 weeks postpartum or with no recorded delivery, 1 year of follow-up and 5 years of follow-up, overall and stratified by breastfeeding status. Reference group: \> 36 weeks or no delivery

  At 1 year and 5 years of follow-up

• Crude Incidence Rate of Uterine Perforation Stratified by IUD Type-first Observed IUD Insertions

  Crude incidence rate was calculated as the number of outcomes occurring during the person-time at risk divided by the total person-time at risk (in person-years)

  Up to 11 years

• Cumulative Incidence of Uterine Perforation Stratified by IUD Type-first Observed IUD Insertions

  Crude estimates of the cumulative incidence, defined as number of outcomes occurring up to a time point out of the number of IUD insertions

  At 1 year and 5 years of follow-up

• Adjusted Hazard Ratio (HR) for IUD Type and Uterine Perforation-first Observed IUD Insertions

  Propensity score-adjusted hazard ratio to evaluate whether the risk of uterine perforation among women with LNG-releasing IUD at the time of first observed IUD insertion differs from the risk of uterine perforation among women with copper IUD at the time of first observed IUD insertion

  Up to 11 years

• Crude Incidence Rate of Uterine Perforation Stratified by Menorrhagia Status-first Observed IUD Insertions

  Crude incidence rate was calculated as the number of outcomes occurring during the person-time at risk divided by the total person-time at risk (in person-years)

  Up to 11 years

• Cumulative Incidence of Uterine Perforation Stratified by Menorrhagia Status-first Observed IUD Insertions

  Crude estimates of the cumulative incidence, defined as number of outcomes occurring up to a time point out of the number of IUD insertions

  At 1 year and 5 years of follow-up

• Adjusted Hazard Ratio (HR) for Menorrhagia Status and Uterine Perforation-first Observed IUD Insertions

  Propensity score-adjusted hazard ratio to evaluate whether the risk of uterine perforation among women using an IUD who have at least one diagnosis code indicating menorrhagia in the 12 months before IUD insertion differs from the risk of uterine perforation among women who do not have this indication

  Up to 11 years

• Effect Modification of Breastfeeding Status on Postpartum Timing for Uterine Perforation

  Propensity score-adjusted hazard ratios to evaluate the extent to which breastfeeding status (yes vs. no) modified the association of uterine perforation for women with IUD insertion at different time periods postpartum (i.e., IUD insertion ≤ 14 weeks versus IUD insertion \> 14 weeks postpartum) among women with a recorded delivery within the past 52 weeks at the time of the first observed IUD insertion

  Up to 11 years

• Effect Modification of IUD Type on Breastfeeding Status for Uterine Perforation

  Propensity score-adjusted hazard ratios to evaluate the extent to which type of IUD (LNG-IUD vs. copper IUD) modified the association between uterine perforation and breastfeeding among women who were and were not breastfeeding at the time of first observed IUD insertion

  Up to 11 years

• Effect Modification of IUD Type on Postpartum Timing for Uterine Perforation

  Adjusted for propensity score and breastfeeding status, to evaluate the extent to which type of IUD (LNG-IUD vs. copper IUD) modified the association between uterine perforation and postpartum timing of IUD insertion for women with IUD insertion at different time periods postpartum (i.e., ≤ 6 weeks, \> 6 and ≤ 14 weeks, \> 14 and ≤ 52 weeks) versus IUD insertion more than 52 weeks postpartum, including no recorded delivery within the past 52 weeks, at the time of the first observed IUD insertion. Reference group: LNG-IUD or Copper IUD, \> 52 weeks or no delivery

  Up to 11 years

Secondary Outcomes (20)

• Crude Incidence Rate of IUD Expulsion Stratified by Breastfeeding Status Among Women Within 52 Weeks Postpartum-first Observed IUD Insertions

  Up to 11 years

• Cumulative Incidence of IUD Expulsion Stratified by Breastfeeding Status Among Women Within 52 Weeks Postpartum-first Observed IUD Insertions

  At 1 year and 5 years of follow-up

• Adjusted Hazard Ratio (HR) for Breastfeeding Status and IUD Expulsion-first Observed IUD Insertions

  Up to 11 years

• Crude Incidence Rate of IUD Expulsion Categorized by Postpartum Timing-first Observed IUD Insertions

  Up to 11 years

• Cumulative Incidence of IUD Expulsion Categorized by Postpartum Timing-first Observed IUD Insertions

  At 1 year and 5 years of follow-up

Study Arms (1)

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.

Device: Intrauterine device

Interventions

Intrauterine device DEVICE

Intrauterine devices, e.g. BAY86-5028 (Mirena, Skyla, Kyleena), Liletta and ParaGard

Also known as: Levonorgestrel, Copper IUD

Women with IUD

Eligibility Criteria

• Age: Up to 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with IUD-insertion

You may qualify if:

• 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

You may not qualify if:

• \- Women with more than 50 years of age at the time of the IUD-insertion

Sponsors & Collaborators

• Bayer: lead

Study Sites (4)

Kaiser Permanente Northern California

Oakland, California, 94612, United States

Location

Kaiser Permanente Southern California

Pasadena, California, 91101, United States

Location

Regenstrief Institute

Indianapolis, Indiana, 46202, United States

Location

Kaiser Permanente Washington

Seattle, Washington, 98101, United States

Location

Related Links

• Click here to find results for studies related to Bayer products

MeSH Terms

Conditions

Breast Feeding; Uterine Perforation

Interventions

Intrauterine Devices

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Uterine Rupture; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Rupture; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Contraceptive Devices, Female; Contraceptive Devices; Equipment and Supplies

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer AG

clinical-trials-contact@bayer.com

(+) 1-888-8422937

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2018
• First Posted: November 27, 2018
• Study Start: December 3, 2018
• Primary Completion: November 29, 2019
• Study Completion: November 29, 2019
• Last Updated: December 4, 2020
• Results First Posted: December 4, 2020

Record last verified: 2020-11

Locations

US (4)