Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization
NCT ID: NCT03438682
Last Updated: 2021-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
89203 participants
OBSERVATIONAL
2018-09-30
2021-07-31
Brief Summary
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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 sterilization procedures to answer:
* How many women got pregnant afterwards?
* How many operations did each woman need to become infertile?
* Which complications did women have (i.e. chronic pain, depression)? We will also check whether certain women (such as certain age groups or those with diabetes) were most likely to have problems after either procedure.
Detailed Description
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Aim 1. To compare the real world effectiveness of hysteroscopic sterilization, laparoscopic sterilization and intrauterine devices (IUDs) by calculating:
1. Pregnancy rates at 3, 6, 12, 24, 36, 48, and 60 months post-procedure, indicating sterilization failure.
2. Patient's ability to rely on sterilization after hysteroscopic sterilization (blocked tubes on hysterosalpingogram) compared to laparoscopic sterilization and IUDs at 3, 6, 12, 24, 36, 48, and 60 months post-procedure, indicating concern of sterilization failure.
Aim 2. To compare safety and complications after hysteroscopic sterilization laparoscopic sterilization, and IUD placement by:
1. Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement at 3, 6, 12, 24, 36, 48, and 60 months post-procedure.
2. Evaluating other outcomes suggested by patient partners, including additional surgeries due to complications, chronic pain, and/or depression, by measuring claims for narcotic prescriptions, and antidepressants at 3, 6, 12, 24, 36, 48, 60 months post-procedure (hysteroscopic sterilization, laparoscopic sterilization, or IUD placement).
3. Identify sociodemographic and pre-sterilization clinical variables which may predict complications following hysteroscopic sterilization compared to laparoscopic sterilization and to IUDs.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Essure Hysteroscopic Sterilization
Women who have undergone Essure hysteroscopic sterilization
Essure
Essure hysteroscopic sterilization
Laparoscopic Sterilization
Women who have undergone laparoscopic sterilization
Laparoscopic sterilization
Laparoscopic sterilization via electrocautery, ring, or clip.
Intrauterine device (IUD) placement
Women who have undergone IUD placement
Intrauterine Device (IUD)
Intrauterine Device (IUD)
Interventions
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Essure
Essure hysteroscopic sterilization
Laparoscopic sterilization
Laparoscopic sterilization via electrocautery, ring, or clip.
Intrauterine Device (IUD)
Intrauterine Device (IUD)
Eligibility Criteria
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Inclusion Criteria
* Claims indicating hysteroscopic or laparoscopic sterilization procedures or IUD placement
Exclusion Criteria
* Any conditions that would have excluded the patient for hysteroscopic sterilization
* Any conditions that would have excluded the patient for laparoscopic sterilization
18 Years
50 Years
FEMALE
Yes
Sponsors
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University of California, Davis
OTHER
National Center for Health Research
UNKNOWN
Patient-Centered Outcomes Research Institute
OTHER
Food and Drug Administration (FDA)
FED
Yale University
OTHER
Responsible Party
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Principal Investigators
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Aileen Gariepy, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale University School of Medicine
New Haven, Connecticut, United States
Countries
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References
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Gariepy AM, Lewis C, Zuckerman D, Tancredi DJ, Murphy E, McDonald-Mosley R, Sonalkar S, Hathaway M, Nunez-Eddy C, Schwarz EB. Comparative effectiveness of hysteroscopic and laparoscopic sterilization for women: a retrospective cohort study. Fertil Steril. 2022 Jun;117(6):1322-1331. doi: 10.1016/j.fertnstert.2022.03.001. Epub 2022 Apr 12.
Schwarz EB, Lewis CA, Dove MS, Murphy E, Zuckerman D, Nunez-Eddy C, Tancredi DJ, McDonald-Mosley R, Sonalkar S, Hathaway M, Gariepy AM. Comparative Effectiveness and Safety of Intrauterine Contraception and Tubal Ligation. J Gen Intern Med. 2022 Dec;37(16):4168-4175. doi: 10.1007/s11606-022-07433-4. Epub 2022 Feb 23.
Gariepy AM, Lewis C, Zuckerman D, Tancredi DJ, Murphy E, McDonald-Mosley R, Sonalkar S, Hathaway M, Nunez-Eddy C, Schwarz EB. Patient-Centered Safety Outcomes After Hysteroscopic Compared With Laparoscopic Sterilization. Obstet Gynecol. 2022 Mar 1;139(3):423-432. doi: 10.1097/AOG.0000000000004690.
Related Links
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This work was (partially) supported through a Patient-Centered Outcomes Research Institute (PCORI) Award 1609-36359
Other Identifiers
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2000020734
Identifier Type: -
Identifier Source: org_study_id