Intrauterine DevicesAPEX IUDNCT03754556

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

An observational study of Intrauterine Devices, run by Bayer at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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). Read more about this study

Who is it for?: Ages Up to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for: Intrauterine Devices
What is being tested?: Intrauterine device
Type of treatment: Medical device
How many people: 326,658 participants
Where: 4 sitesUnited States
Study dates: 3 Dec 2018to 29 Nov 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 50 years
Women only
Healthy volunteers accepted
Child, Adult

Study population: Women with IUD-insertion

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Regenstrief Institute
Indianapolis, Indiana, 46202
Kaiser Permanente Northern California
Oakland, California, 94612
Kaiser Permanente Southern California
Pasadena, California, 91101
Kaiser Permanente Washington
Seattle, Washington, 98101

Other trials in United States

About this study

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

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
Being tested: Intrauterine device
Keywords: Contraception, Breast-feeding, Electronic medical records, Uterine perforation, Expulsion of intrauterine device
Medical subject headings: Breast Feeding, Uterine Perforation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intrauterine deviceDevice
Also called Levonorgestrel, Copper IUD
Intrauterine devices, e.g. BAY86-5028 (Mirena, Skyla, Kyleena), Liletta and ParaGard

Study groups in NCT03754556
Study group	Role	What they receive
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. Receives: Device: Intrauterine device

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
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)
Measured: Up to 11 years
Cumulative Incidence of IUD Expulsion 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
Measured: At 1 year and 5 years of follow-up
Adjusted Hazard Ratio (HR) for Breastfeeding Status and IUD Expulsion-first Observed IUD Insertions
Propensity score-adjusted to evaluate whether the risk of IUD expulsion among women who were breastfeeding at the time of first observed IUD insertion differs from the risk of IUD expulsion among women who were not breastfeeding at the time of first observed IUD insertion
Measured: Up to 11 years
Crude Incidence Rate of IUD Expulsion 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)
Measured: Up to 11 years
Cumulative Incidence of IUD Expulsion 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
Measured: At 1 year and 5 years of follow-up
Adjusted Hazard Ratio (HR) for Postpartum Timing and IUD Expulsion-first Observed IUD Insertions
Adjusted for propensity score and breastfeeding status, to evaluate whether the risk of IUD expulsion before and after 49 days of insertion among women who had a first observed IUD insertion within different time periods postpartum differs from the risk of IUD expulsion 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
Measured: Up to 11 years
Adjusted Hazard Ratio (HR) for Postpartum Timing Risk 14-week Cut Point and IUD Expulsion-first Observed IUD Insertions
Adjusted for propensity scores, to estimate the risk of IUD expulsion 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
Measured: Up to 11 years
Adjusted Hazard Ratio (HR) for Postpartum Timing Risk 36-week Cut Point and IUD Expulsion-first Observed IUD Insertions
Adjusted for propensity scores, to estimate the risk of IUD expulsion 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
Measured: Up to 11 years
Adjusted Incidence Rate Ratio (IRR) for IUD Expulsion-first Observed IUD Insertions
Overall and stratified by breastfeeding status at the time of IUD insertion for IUD expulsion 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
Measured: At 1 year and 5 years of follow-up
Adjusted Incidence Rate Difference (IRD) for IUD Expulsion-first Observed IUD Insertions
Adjusted incidence rate differences (per 1,000 person-years) for IUD expulsion 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
Measured: At 1 year and 5 years of follow-up
Crude Incidence Rate of IUD Expulsion 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)
Measured: Up to 11 years
Cumulative Incidence of IUD Expulsion 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
Measured: At 1 year and 5 years of follow-up
Adjusted Hazard Ratio (HR) for IUD Type and IUD Expulsion-first Observed IUD Insertions
Propensity score adjusted to evaluate whether the risk of IUD expulsion among women with LNG-releasing IUD at the time of first observed IUD insertion differs from the risk of IUD expulsion among women with copper IUD at the time of first observed IUD insertion
Measured: Up to 11 years
Crude Incidence Rate of IUD Expulsion 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)
Measured: Up to 11 years
Cumulative Incidence of IUD Expulsion 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
Measured: At 1 year and 5 years of follow-up
Adjusted Hazard Ratio (HR) for Menorrhagia Status and IUD Expulsion-first Observed IUD Insertions
Propensity score adjusted to evaluate whether the risk of IUD expulsion 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 IUD expulsion among women who do not have this indication
Measured: Up to 11 years
Effect Modification of IUD Type on Breastfeeding Status for IUD Expulsion
Propensity score-adjusted hazard ratios to evaluate the extent to which type of IUD (LNG-IUD vs. copper IUD) modified the association between IUD expulsion and breastfeeding among women who were and were not breastfeeding at the time of first observed IUD insertion
Measured: Up to 11 years
Effect Modification of IUD Type on Postpartum Timing for IUD Expulsion
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 IUD expulsion 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
Measured: Up to 11 years
Number of Indicators of a Potentially Difficult Insertion, Overall, by Breastfeeding Status, and by Postpartum Timing of IUD Insertion-first Observed IUD Insertions
To describe the prevalence of indicators of a difficult IUD insertion (e.g., need for cervical dilation, ultrasound guidance, paracervical block, clinician not indicating difficulty, use of misoprostol among all users)
Measured: Up to 11 years
Number of Indicators of a Potentially Difficult Insertion, Overall, by IUD Type and by Menorrhagia Status-first Observed IUD Insertions
To describe the prevalence of indicators of a difficult IUD insertion (e.g., need for cervical dilation, ultrasound guidance, paracervical block, clinician not indicating difficulty, use of misoprostol among all users)
Measured: Up to 11 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Dec 201829 Nov 2019

First posted27 Nov 2018
Study start3 Dec 2018
Primary completion29 Nov 2019
Study completion29 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Intrauterine DevicesStudies of the same condition, open and under way.
More trials run by BayerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 326,658 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03754556
Sponsor's protocol ID: 19682
Acronym: APEX IUD
Status last verified: Nov 2020
First submitted: 23 Nov 2018
Last updated: 4 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer
Atypical Endometrial Hyperplasia, Stage I Uterine Corpus Cancer AJCC v7
RecruitingObservational study
Postprandial Glucose Handing in Contraceptive and IUD Users
Glucose Homeostasis
RecruitingObservational study
Primitive Immunodeficiency, Intrauterine Devices and Menstrual Hygiene Products
Primary Immune Deficiency Diseases
RecruitingPhase 2
A Study to Estimate Early Clinical Efficacy Signals of GLP-1 Agonist Administration in Conjunction With Levonorgestrel Intrauterine Device in Obese Patients With Endometrioid Intraepithelial Neoplasia
Endometrioid Endometrial Adenocarcinoma
Recruiting
Effect of Periumbilical Vibration on Pain Perception During Intrauterine Device Insertion: A Randomized Controlled Trial
Intrauterine Device Placement

All Intrauterine Devices trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03754556
Acronym / sponsor ID: APEX IUD / 19682
Conditions: Intrauterine Devices
Keywords: Contraception, Breast-feeding, Electronic medical records, Uterine perforation, Expulsion of intrauterine device
Study type: Observational
Recruitment status: Completed
Enrolment: 326,658 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: 3 Dec 2018 (actual)
Primary completion: 29 Nov 2019 (actual)
Study completion: 29 Nov 2019 (actual)
First posted: 27 Nov 2018 (actual)
Results: Posted 4 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Women with IUD	–	Device: Intrauterine deviceWomen 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.

Who may qualify

Ages: Up to 50 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult
Study population: Women with IUD-insertion

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intrauterine deviceAlso: Levonorgestrel, Copper IUDIntrauterine devices, e.g. BAY86-5028 (Mirena, Skyla, Kyleena), Liletta and ParaGard	Device	Women with IUD

Primary outcome

Crude Incidence Rate of Uterine Perforation Stratified by Breastfeeding Status Among Women Within 52 Weeks Postpartum-first Observed IUD Insertions
Time frame: Up to 11 years
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)
Cumulative Incidence of Uterine Perforation Stratified by Breastfeeding Status Among Women Within 52 Weeks Postpartum-first Observed IUD Insertions
Time frame: At 1 year and 5 years of follow-up
Crude estimates of the cumulative incidence, defined as number of outcomes occurring up to a time point out of the number of IUD insertions
Adjusted Hazard Ratio (HR) for Breastfeeding Status and Uterine Perforation-first Observed IUD Insertions
Time frame: Up to 11 years
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
Crude Incidence Rate of Uterine Perforation Categorized by Postpartum Timing-first Observed IUD Insertions
Time frame: Up to 11 years
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)
Cumulative Incidence of Uterine Perforation Categorized by Postpartum Timing-first Observed IUD Insertions
Time frame: At 1 year and 5 years of follow-up
Crude estimates of the cumulative incidence, defined as number of outcomes occurring up to a time point out of the number of IUD insertions
Adjusted Hazard Ratio (HR) for Postpartum Timing and Uterine Perforation-first Observed IUD Insertions
Time frame: Up to 11 years
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
Adjusted Hazard Ratio (HR) for Postpartum Timing Risk 14-week Cut Point and Uterine Perforation-first Observed IUD Insertions
Time frame: Up to 11 years
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
Adjusted Hazard Ratio (HR) for Postpartum Timing Risk 36-week Cut Point and Uterine Perforation-first Observed IUD Insertions
Time frame: Up to 11 years
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
Adjusted Incidence Rate Ratio (IRR) for Uterine Perforation-first Observed IUD Insertions
Time frame: At 1 year and 5 years of follow-up
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
Adjusted Incidence Rate Difference (IRD) for Uterine Perforation-first Observed IUD Insertions
Time frame: At 1 year and 5 years of follow-up
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
Crude Incidence Rate of Uterine Perforation Stratified by IUD Type-first Observed IUD Insertions
Time frame: Up to 11 years
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)
Cumulative Incidence of Uterine Perforation Stratified by IUD Type-first Observed IUD Insertions
Time frame: At 1 year and 5 years of follow-up
Crude estimates of the cumulative incidence, defined as number of outcomes occurring up to a time point out of the number of IUD insertions
Adjusted Hazard Ratio (HR) for IUD Type and Uterine Perforation-first Observed IUD Insertions
Time frame: Up to 11 years
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
Crude Incidence Rate of Uterine Perforation Stratified by Menorrhagia Status-first Observed IUD Insertions
Time frame: Up to 11 years
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)
Cumulative Incidence of Uterine Perforation Stratified by Menorrhagia Status-first Observed IUD Insertions
Time frame: At 1 year and 5 years of follow-up
Crude estimates of the cumulative incidence, defined as number of outcomes occurring up to a time point out of the number of IUD insertions
Adjusted Hazard Ratio (HR) for Menorrhagia Status and Uterine Perforation-first Observed IUD Insertions
Time frame: Up to 11 years
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
Effect Modification of Breastfeeding Status on Postpartum Timing for Uterine Perforation
Time frame: Up to 11 years
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
Effect Modification of IUD Type on Breastfeeding Status for Uterine Perforation
Time frame: Up to 11 years
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
Effect Modification of IUD Type on Postpartum Timing for Uterine Perforation
Time frame: Up to 11 years
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

20 secondary outcomes

Crude Incidence Rate of IUD Expulsion Stratified by Breastfeeding Status Among Women Within 52 Weeks Postpartum-first Observed IUD Insertions
Time frame: Up to 11 years
Cumulative Incidence of IUD Expulsion Stratified by Breastfeeding Status Among Women Within 52 Weeks Postpartum-first Observed IUD Insertions
Time frame: At 1 year and 5 years of follow-up
Adjusted Hazard Ratio (HR) for Breastfeeding Status and IUD Expulsion-first Observed IUD Insertions
Time frame: Up to 11 years
Crude Incidence Rate of IUD Expulsion Categorized by Postpartum Timing-first Observed IUD Insertions
Time frame: Up to 11 years
Cumulative Incidence of IUD Expulsion Categorized by Postpartum Timing-first Observed IUD Insertions
Time frame: At 1 year and 5 years of follow-up
Adjusted Hazard Ratio (HR) for Postpartum Timing and IUD Expulsion-first Observed IUD Insertions
Time frame: Up to 11 years
Adjusted Hazard Ratio (HR) for Postpartum Timing Risk 14-week Cut Point and IUD Expulsion-first Observed IUD Insertions
Time frame: Up to 11 years
Adjusted Hazard Ratio (HR) for Postpartum Timing Risk 36-week Cut Point and IUD Expulsion-first Observed IUD Insertions
Time frame: Up to 11 years
Adjusted Incidence Rate Ratio (IRR) for IUD Expulsion-first Observed IUD Insertions
Time frame: At 1 year and 5 years of follow-up
Adjusted Incidence Rate Difference (IRD) for IUD Expulsion-first Observed IUD Insertions
Time frame: At 1 year and 5 years of follow-up
Crude Incidence Rate of IUD Expulsion Stratified by IUD Type-first Observed IUD Insertions
Time frame: Up to 11 years
Cumulative Incidence of IUD Expulsion Stratified by IUD Type-first Observed IUD Insertions
Time frame: At 1 year and 5 years of follow-up
Adjusted Hazard Ratio (HR) for IUD Type and IUD Expulsion-first Observed IUD Insertions
Time frame: Up to 11 years
Crude Incidence Rate of IUD Expulsion Stratified by Menorrhagia Status-first Observed IUD Insertions
Time frame: Up to 11 years
Cumulative Incidence of IUD Expulsion Stratified by Menorrhagia Status-first Observed IUD Insertions
Time frame: At 1 year and 5 years of follow-up
Adjusted Hazard Ratio (HR) for Menorrhagia Status and IUD Expulsion-first Observed IUD Insertions
Time frame: Up to 11 years
Effect Modification of IUD Type on Breastfeeding Status for IUD Expulsion
Time frame: Up to 11 years
Effect Modification of IUD Type on Postpartum Timing for IUD Expulsion
Time frame: Up to 11 years
Number of Indicators of a Potentially Difficult Insertion, Overall, by Breastfeeding Status, and by Postpartum Timing of IUD Insertion-first Observed IUD Insertions
Time frame: Up to 11 years
Number of Indicators of a Potentially Difficult Insertion, Overall, by IUD Type and by Menorrhagia Status-first Observed IUD Insertions
Time frame: Up to 11 years

Results and safety

Results posted to the registry on 4 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Women With IUD	326,658	326,658

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

Time frame: Up to 11 years. Number (95% Confidence Interval). Unit: per 1000 person-years

Measure	Women With IUD n = 94817
Breastfeeding	4.25 (3.89 to 4.62)
Not breastfeeding	2.50 (2.11 to 2.94)

Population analysed: Women who were within 52 weeks postpartum and were or were not breastfeeding at the time of IUD insertion

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

Time frame: At 1 year and 5 years of follow-up. Number (95% Confidence Interval). Unit: number of outcomes/IUD insertions (%)

Measure	Women With IUD n = 94817
Breastfeeding, 1 year of follow-up	0.60 (0.54 to 0.67)
Not breastfeeding, 1 year of follow-up	0.35 (0.29 to 0.43)
Breastfeeding, 5 years of follow-up	1.61 (1.43 to 1.81)
Not breastfeeding, 5 years of follow-up	0.88 (0.71 to 1.08)

Population analysed: Women who were within 52 weeks postpartum and were or were not breastfeeding at the time of IUD insertion

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

Time frame: Up to 11 years. Number (95% Confidence Interval). Unit: ajusted hazard ratio

Measure	Women With IUD n = 94817
Value	1.37 (1.12 to 1.66)

Population analysed: Women who had given birth in the previous 52 weeks and had breastfeeding status "yes" or "no" were included in this analysis

Primary outcome: Crude Incidence Rate of Uterine Perforation Categorized by Postpartum Timing-first Observed IUD Insertions

Time frame: Up to 11 years. Number (95% Confidence Interval). Unit: per 1000 person-years

Measure	Women With IUD n = 326658
≤ 6 weeks postpartum	5.14 (4.44 to 5.92)
> 6 weeks and ≤ 14 weeks postpartum	3.77 (3.42 to 4.15)
> 14 weeks and ≤ 52 weeks postpartum	2.24 (1.80 to 2.75)
> 52 weeks postpartum or no delivery	0.68 (0.61 to 0.76)

Population analysed: Women with first observed IUD insertions at different postpartum timing or women without recorded delivery within the past 52 weeks

20 secondary outcomes are reported in the full results.

Adverse events

Time frame: Retrospective analysis of data from 2001 to 2018. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Women With IUD	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Intrauterine Devices, run by Bayer at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Crude Incidence Rate of Uterine Perforation Stratified by Breastfeeding Status Among Women Within 52 Weeks Postpartum-first Observed IUD Insertions (time frame: Up to 11 years). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03754556.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2020.