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NCT03438682 · ClinicalTrials.gov registry record
Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization
A clinical trial, sponsored by Yale University.
- Completed
- Registry status
- 89,203
- Enrollment target
NCT03438682 is a clinical trial that has completed, run by Yale University. The registered enrollment target is 89,203 participants.
The verdict
NCT03438682 has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- 89,203 participants
- Enrollment target
Study Summary
More than 345,000 U.S. women undergo either tubal ligation ("getting her tubes tied") or Essure procedures each year to permanently avoid pregnancy. Both prevent pregnancy by blocking women's Fallopian tubes but neither are 100% effective. Both can have complications, but not enough is known to help women make an informed choice between the two. Essure is popular because it can be performed without anesthesia in a doctor's office and women can return to work the next day. However, patients have reported that the Essure procedure was unexpectedly painful. Also, women need to use other contraceptives for 3 months and then return for testing, to make sure their tubes are blocked and will prevent pregnancy. Not all women return for this test and some may get pregnant before realizing their Essure didn't work. Essure was approved by the Food and Drug Administration (FDA) in 2002, but no studies ever compared it to tubal ligation. By 2015, over 9,000 women reported serious complications to the FDA. Women who were unhappy with Essure found each other online and created a Facebook "Essure Problems" support group that now has over 31,000 members. After an FDA Advisory Board expressed concerns about Essure's risks, in 2016 the FDA required stronger warnings about complications and announced that "more rigorous research" was needed, demanding Essure's maker conduct a new study comparing the benefits and risks of Essure to tubal ligation. Unfortunately, that study will not be finished before September 2023. To provide answers as rapidly as possible for women considering sterilization, we will analyze data from the medical records of thousands of women with sterilization procedures funded by California's Medicaid. As poor women and women of color have different experiences with healthcare, and they more often choose sterilization, comparing these women's experiences with Essure and tubal ligation is very important. We will compare the safety and effectiveness of the 2 sterili
Interventions
- DEVICE Essure
- PROCEDURE Laparoscopic sterilization
- DEVICE Intrauterine Device (IUD)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89,203 participants |
| Start Date | 2018-09-30 |
| Est. Completion | 2021-07-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03438682
The ClinicalTrials.gov registry entry for NCT03438682 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 89,203 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Essure is the first listed.
NCT03438682 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03438682 about?
NCT03438682 is a clinical study titled "Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization". More than 345,000 U.S. women undergo either tubal ligation ("getting her tubes tied") or Essure procedures each year to permanently avoid pregnancy. Both prevent pregnancy by blocking women's Fallopian tubes but neither are 100% effective. Both can have complications, but not enough is known to help...
What is the current status of trial NCT03438682?
This trial is currently completed. The enrollment target is 89,203 participants. The study started on 2018-09-30. Estimated completion is 2021-07-31.
What interventions are being tested in trial NCT03438682?
The interventions under investigation include: Essure (DEVICE), Laparoscopic sterilization (PROCEDURE), Intrauterine Device (IUD) (DEVICE).
Who is sponsoring clinical trial NCT03438682?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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