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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01FD005938-01 | U.S. FDA Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of California, Davis | OTHER |
| National Center for Health Research | UNKNOWN |
| Patient-Centered Outcomes Research Institute | OTHER |
| Food and Drug Administration (FDA) |
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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 sterilization procedures to answer:
Study Aims:
Aim 1. To compare the real world effectiveness of hysteroscopic sterilization, laparoscopic sterilization and intrauterine devices (IUDs) by calculating:
Aim 2. To compare safety and complications after hysteroscopic sterilization laparoscopic sterilization, and IUD placement by:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Essure Hysteroscopic Sterilization | Women who have undergone Essure hysteroscopic sterilization |
| |
| Laparoscopic Sterilization | Women who have undergone laparoscopic sterilization |
| |
| Intrauterine device (IUD) placement | Women who have undergone IUD placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Essure | Device | Essure hysteroscopic sterilization |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a) | Pregnancy after sterilization or IUD placement, indicating failure | Pregnancy rates at 3 months post-procedure |
| Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a) | Pregnancy after sterilization or IUD placement, indicating failure | Pregnancy rates at 6 months post-procedure |
| Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a) | Pregnancy after sterilization or IUD placement, indicating failure | Pregnancy rates at 12 months post-procedure |
| Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a) | Pregnancy after sterilization or IUD placement, indicating failure | Pregnancy rates at 24 months post-procedure |
| Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a) | Pregnancy after sterilization or IUD placement, indicating failure | Pregnancy rates at 36 months post-procedure |
| Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a) | Pregnancy after sterilization or IUD placement, indicating failure | Pregnancy rates at 48 months post-procedure |
| Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a) |
| Measure | Description | Time Frame |
|---|---|---|
| Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) | Ability to rely on sterilization after hysteroscopic sterilization (assessed by having blocked tubes on post-procedure hysterosalpingogram test) compared to laparoscopic sterilization and IUDs | 3 months post-procedure |
| Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) |
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Inclusion Criteria:
Exclusion Criteria:
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We will use linked data from Centers for Medicare and Medicaid Services (CMS) Research Data Assistance Center (ResDAC) including research identifiable files (RIF) containing Medicaid records, known as the Medicaid Analytic Extract (MAX) files to identify women who have undergone hysteroscopic or laparoscopic sterilization procedures or IUD placement. The MAX files contain claims, encounters, and eligibility information on recipients of California's Medicaid program (Medi-Cal).
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| Name | Affiliation | Role |
|---|---|---|
| Aileen Gariepy, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06510 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35428480 | Derived | 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. | |
| 35194746 | Derived | 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. |
| Label | URL |
|---|---|
| This work was (partially) supported through a Patient-Centered Outcomes Research Institute (PCORI) Award 1609-36359 | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 29, 2022 | |
| Reset | Jun 30, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 29, 2022 | Jun 30, 2023 |
| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D007434 | Intrauterine Devices |
| ID | Term |
|---|---|
| D003274 | Contraceptive Devices, Female |
| D003273 | Contraceptive Devices |
| D004864 | Equipment and Supplies |
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| FED |
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| Laparoscopic sterilization |
| Procedure |
Laparoscopic sterilization via electrocautery, ring, or clip. |
|
| Intrauterine Device (IUD) | Device | Intrauterine Device (IUD) |
|
Pregnancy after sterilization or IUD placement, indicating failure |
| Pregnancy rates at 60 months post-procedure |
Ability to rely on sterilization after hysteroscopic sterilization (assessed by having blocked tubes on post-procedure hysterosalpingogram test) compared to laparoscopic sterilization and IUDs |
| 6 months post-procedure |
| Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) | Ability to rely on sterilization after hysteroscopic sterilization (assessed by having blocked tubes on post-procedure hysterosalpingogram test) compared to laparoscopic sterilization and IUDs | 12 months post-procedure |
| Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) | Ability to rely on sterilization after hysteroscopic sterilization (assessed by having blocked tubes on post-procedure hysterosalpingogram test) compared to laparoscopic sterilization and IUDs | 24 months post-procedure |
| Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) | Ability to rely on sterilization after hysteroscopic sterilization (assessed by having blocked tubes on post-procedure hysterosalpingogram test) compared to laparoscopic sterilization and IUDs | 36 months post-procedure |
| Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) | Ability to rely on sterilization after hysteroscopic sterilization (assessed by having blocked tubes on post-procedure hysterosalpingogram test) compared to laparoscopic sterilization and IUDs | 48 months post-procedure |
| Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) | Ability to rely on sterilization after hysteroscopic sterilization (assessed by having blocked tubes on post-procedure hysterosalpingogram test) compared to laparoscopic sterilization and IUDs | 60 months post-procedure |
| Reoperation to achieve sterilization or reinsertion to achieve IUD placement | Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement | 3 months post-procedure |
| Reoperation to achieve sterilization or reinsertion to achieve IUD placement | Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement | 6 months post-procedure |
| Reoperation to achieve sterilization or reinsertion to achieve IUD placement | Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement | 12 months post-procedure |
| Reoperation to achieve sterilization or reinsertion to achieve IUD placement | Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement | 24 months post-procedure |
| Reoperation to achieve sterilization or reinsertion to achieve IUD placement | Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement | 36 months post-procedure |
| Reoperation to achieve sterilization or reinsertion to achieve IUD placement | Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement | 48 months post-procedure |
| Reoperation to achieve sterilization or reinsertion to achieve IUD placement | Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement | 60 months post-procedure |
| Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) | Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy | 3 months post-procedure |
| Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) | Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy | 6 months post-procedure |
| Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) | Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy | 12 months post-procedure |
| Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) | Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy | 24 months post-procedure |
| Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) | Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy | 36 months post-procedure |
| Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) | Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy | 48 months post-procedure |
| Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) | Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy | 60 months post-procedure |
| Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics | New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement | 3 months post-procedure |
| Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics | New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement | 6 months post-procedure |
| Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics | New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement | 12 months post-procedure |
| Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics | New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement | 24 months post-procedure |
| Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics | New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement | 36 months post-procedure |
| Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics | New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement | 48 months post-procedure |
| Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics | New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement | 60 months post-procedure |
| Number of participants with new onset depression as assessed by new prescriptions for antidepressants | New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement | 3 months post-procedure |
| Number of participants with new onset depression as assessed by new prescriptions for antidepressants | New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement | 6 months post-procedure |
| Number of participants with new onset depression as assessed by new prescriptions for antidepressants | New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement | 12 months post-procedure |
| Number of participants with new onset depression as assessed by new prescriptions for antidepressants | New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement | 24 months post-procedure |
| Number of participants with new onset depression as assessed by new prescriptions for antidepressants | New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement | 36 months post-procedure |
| Number of participants with new onset depression as assessed by new prescriptions for antidepressants | New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement | 48 months post-procedure |
| Number of participants with new onset depression as assessed by new prescriptions for antidepressants | New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement | 60 months post-procedure |
| Pre-procedure clinical variables associated with procedural complications | Identify sociodemographic and pre-procedure clinical variables which may predict complications following hysteroscopic sterilization compared to laparoscopic sterilization and IUD placement | Up to 1-year pre-procedure |
| 35115444 | Derived | 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. |
| D000091662 | Genital Diseases |
| D007246 | Infertility |