Trial Condition(s):

Intrauterine Devices

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 (APEX IUD)

Bayer Identifier:

19682

ClinicalTrials.gov Identifier:

NCT03754556

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
326658
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Kaiser Permanente Northern California

Oakland, United States, 94612

Status
Completed
 
Locations

Kaiser Permanente Southern California

Pasadena, United States, 91101

Status
Completed
 
Locations

Kaiser Permanente Washington

Seatle, United States, 98101

Status
Completed
 
Locations

Regenstrief Institute

Indianapolis, United States, 46202

Status
Completed
 

Trial Design