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NCT03754556 · ClinicalTrials.gov registry record
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
A clinical trial, sponsored by Bayer.
- Completed
- Registry status
- 326,658
- Enrollment target
NCT03754556: Completed study, sponsored by Bayer.
NCT03754556 is a clinical trial that has completed, run by Bayer. The registered enrollment target is 326,658 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03754556 has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- 326,658 participants
- Enrollment target
Study 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.
Primary Outcome
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)
Interventions
- DEVICE Intrauterine device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 326,658 participants |
| Start Date | 2018-12-03 |
| Est. Completion | 2019-11-29 |
What the finished NCT03754556 record still lists
NCT03754556 is an observational study that tracks outcomes without assigning an intervention. Its 326,658 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which Intrauterine device is the first listed.
NCT03754556 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03754556 about?
NCT03754556 is a clinical study titled "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". 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 th...
What is the current status of trial NCT03754556?
This trial is currently completed. The enrollment target is 326,658 participants. The study started on 2018-12-03. Estimated completion is 2019-11-29.
What interventions are being tested in trial NCT03754556?
The interventions under investigation include: Intrauterine device (DEVICE).
Who is sponsoring clinical trial NCT03754556?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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