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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 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 326658

Last updated 2020-12-04

Study results available
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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

Interventions

DEVICE

Intrauterine device

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

Sponsors & Collaborators

Eligibility

Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-03
Primary Completion
2019-11-29
Completion
2019-11-29

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03754556 on ClinicalTrials.gov