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Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03438682
Recruitment Status : Active, not recruiting
First Posted : February 20, 2018
Last Update Posted : May 22, 2020
Sponsor:
Collaborators:
University of California, Davis
National Center for Health Research
Patient-Centered Outcomes Research Institute
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date January 29, 2018
First Posted Date February 20, 2018
Last Update Posted Date May 22, 2020
Actual Study Start Date September 30, 2018
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 17, 2018)
  • Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a) [ Time Frame: Pregnancy rates at 3 months post-procedure ]
    Pregnancy after sterilization or IUD placement, indicating failure
  • Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a) [ Time Frame: Pregnancy rates at 6 months post-procedure ]
    Pregnancy after sterilization or IUD placement, indicating failure
  • Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a) [ Time Frame: Pregnancy rates at 12 months post-procedure ]
    Pregnancy after sterilization or IUD placement, indicating failure
  • Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a) [ Time Frame: Pregnancy rates at 24 months post-procedure ]
    Pregnancy after sterilization or IUD placement, indicating failure
  • Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a) [ Time Frame: Pregnancy rates at 36 months post-procedure ]
    Pregnancy after sterilization or IUD placement, indicating failure
  • Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a) [ Time Frame: Pregnancy rates at 48 months post-procedure ]
    Pregnancy after sterilization or IUD placement, indicating failure
  • Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a) [ Time Frame: Pregnancy rates at 60 months post-procedure ]
    Pregnancy after sterilization or IUD placement, indicating failure
Original Primary Outcome Measures
 (submitted: February 12, 2018)
  • Effectiveness of hysteroscopic compared to laparoscopic sterilization (Aim 1a) [ Time Frame: Pregnancy rates at 3 months post-procedure ]
    Pregnancy after sterilization, indicating sterilization failure
  • Effectiveness of hysteroscopic compared to laparoscopic sterilization (Aim 1a) [ Time Frame: Pregnancy rates at 6 months post-procedure ]
    Pregnancy after sterilization, indicating sterilization failure
  • Effectiveness of hysteroscopic compared to laparoscopic sterilization (Aim 1a) [ Time Frame: Pregnancy rates at 12 months post-procedure ]
    Pregnancy after sterilization, indicating sterilization failure
  • Effectiveness of hysteroscopic compared to laparoscopic sterilization (Aim 1a) [ Time Frame: Pregnancy rates at 24 months post-procedure ]
    Pregnancy after sterilization, indicating sterilization failure
  • Effectiveness of hysteroscopic compared to laparoscopic sterilization (Aim 1a) [ Time Frame: Pregnancy rates at 36 months post-procedure ]
    Pregnancy after sterilization, indicating sterilization failure
  • Effectiveness of hysteroscopic compared to laparoscopic sterilization (Aim 1a) [ Time Frame: Pregnancy rates at 48 months post-procedure ]
    Pregnancy after sterilization, indicating sterilization failure
  • Effectiveness of hysteroscopic compared to laparoscopic sterilization (Aim 1a) [ Time Frame: Pregnancy rates at 60 months post-procedure ]
    Pregnancy after sterilization, indicating sterilization failure
Change History
Current Secondary Outcome Measures
 (submitted: May 17, 2018)
  • Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) [ Time Frame: 3 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
  • Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) [ Time Frame: 6 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
  • Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) [ Time Frame: 12 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
  • Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) [ Time Frame: 24 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
  • Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) [ Time Frame: 36 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
  • Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) [ Time Frame: 48 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
  • Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) [ Time Frame: 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
  • Reoperation to achieve sterilization or reinsertion to achieve IUD placement [ Time Frame: 3 months post-procedure ]
    Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement
  • Reoperation to achieve sterilization or reinsertion to achieve IUD placement [ Time Frame: 6 months post-procedure ]
    Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement
  • Reoperation to achieve sterilization or reinsertion to achieve IUD placement [ Time Frame: 12 months post-procedure ]
    Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement
  • Reoperation to achieve sterilization or reinsertion to achieve IUD placement [ Time Frame: 24 months post-procedure ]
    Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement
  • Reoperation to achieve sterilization or reinsertion to achieve IUD placement [ Time Frame: 36 months post-procedure ]
    Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement
  • Reoperation to achieve sterilization or reinsertion to achieve IUD placement [ Time Frame: 48 months post-procedure ]
    Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement
  • Reoperation to achieve sterilization or reinsertion to achieve IUD placement [ Time Frame: 60 months post-procedure ]
    Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement
  • Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) [ Time Frame: 3 months post-procedure ]
    Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy
  • Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) [ Time Frame: 6 months post-procedure ]
    Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy
  • Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) [ Time Frame: 12 months post-procedure ]
    Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy
  • Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) [ Time Frame: 24 months post-procedure ]
    Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy
  • Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) [ Time Frame: 36 months post-procedure ]
    Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy
  • Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) [ Time Frame: 48 months post-procedure ]
    Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy
  • Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) [ Time Frame: 60 months post-procedure ]
    Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy
  • Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics [ Time Frame: 3 months post-procedure ]
    New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement
  • Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics [ Time Frame: 6 months post-procedure ]
    New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement
  • Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics [ Time Frame: 12 months post-procedure ]
    New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement
  • Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics [ Time Frame: 24 months post-procedure ]
    New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement
  • Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics [ Time Frame: 36 months post-procedure ]
    New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement
  • Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics [ Time Frame: 48 months post-procedure ]
    New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement
  • Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics [ Time Frame: 60 months post-procedure ]
    New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement
  • Number of participants with new onset depression as assessed by new prescriptions for antidepressants [ Time Frame: 3 months post-procedure ]
    New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement
  • Number of participants with new onset depression as assessed by new prescriptions for antidepressants [ Time Frame: 6 months post-procedure ]
    New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement
  • Number of participants with new onset depression as assessed by new prescriptions for antidepressants [ Time Frame: 12 months post-procedure ]
    New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement
  • Number of participants with new onset depression as assessed by new prescriptions for antidepressants [ Time Frame: 24 months post-procedure ]
    New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement
  • Number of participants with new onset depression as assessed by new prescriptions for antidepressants [ Time Frame: 36 months post-procedure ]
    New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement
  • Number of participants with new onset depression as assessed by new prescriptions for antidepressants [ Time Frame: 48 months post-procedure ]
    New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement
  • Number of participants with new onset depression as assessed by new prescriptions for antidepressants [ Time Frame: 60 months post-procedure ]
    New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement
  • Pre-procedure clinical variables associated with procedural complications [ Time Frame: Up to 1-year pre-procedure ]
    Identify sociodemographic and pre-procedure clinical variables which may predict complications following hysteroscopic sterilization compared to laparoscopic sterilization and IUD placement
Original Secondary Outcome Measures
 (submitted: February 12, 2018)
  • Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) [ Time Frame: 3 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
  • Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) [ Time Frame: 6 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
  • Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) [ Time Frame: 12 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
  • Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) [ Time Frame: 24 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
  • Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) [ Time Frame: 36 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
  • Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) [ Time Frame: 48 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
  • Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) [ Time Frame: 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
  • Reoperation to achieve sterilization [ Time Frame: 3 months post-procedure ]
    Evaluating rates of reoperation to achieve sterilization
  • Reoperation to achieve sterilization [ Time Frame: 6 months post-procedure ]
    Evaluating rates of reoperation to achieve sterilization
  • Reoperation to achieve sterilization [ Time Frame: 12 months post-procedure ]
    Evaluating rates of reoperation to achieve sterilization
  • Reoperation to achieve sterilization [ Time Frame: 24 months post-procedure ]
    Evaluating rates of reoperation to achieve sterilization
  • Reoperation to achieve sterilization [ Time Frame: 36 months post-procedure ]
    Evaluating rates of reoperation to achieve sterilization
  • Reoperation to achieve sterilization [ Time Frame: 48 months post-procedure ]
    Evaluating rates of reoperation to achieve sterilization
  • Reoperation to achieve sterilization [ Time Frame: 60 months post-procedure ]
    Evaluating rates of reoperation to achieve sterilization
  • Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) [ Time Frame: 3 months post-procedure ]
    Need for second surgical procedure after hysteroscopic or laparoscopic sterilization as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy
  • Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) [ Time Frame: 6 months post-procedure ]
    Need for second surgical procedure after hysteroscopic or laparoscopic sterilization as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy
  • Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) [ Time Frame: 12 months post-procedure ]
    Need for second surgical procedure after hysteroscopic or laparoscopic sterilization as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy
  • Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) [ Time Frame: 24 months post-procedure ]
    Need for second surgical procedure after hysteroscopic or laparoscopic sterilization as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy
  • Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) [ Time Frame: 36 months post-procedure ]
    Need for second surgical procedure after hysteroscopic or laparoscopic sterilization as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy
  • Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) [ Time Frame: 48 months post-procedure ]
    Need for second surgical procedure after hysteroscopic or laparoscopic sterilization as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy
  • Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) [ Time Frame: 60 months post-procedure ]
    Need for second surgical procedure after hysteroscopic or laparoscopic sterilization as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy
  • Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics [ Time Frame: 3 months post-procedure ]
    New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization
  • Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics [ Time Frame: 6 months post-procedure ]
    New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization
  • Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics [ Time Frame: 12 months post-procedure ]
    New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization
  • Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics [ Time Frame: 24 months post-procedure ]
    New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization
  • Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics [ Time Frame: 36 months post-procedure ]
    New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization
  • Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics [ Time Frame: 48 months post-procedure ]
    New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization
  • Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics [ Time Frame: 60 months post-procedure ]
    New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization
  • Number of participants with new onset depression as assessed by new prescriptions for antidepressants [ Time Frame: 3 months post-procedure ]
    New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization
  • Number of participants with new onset depression as assessed by new prescriptions for antidepressants [ Time Frame: 6 months post-procedure ]
    New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization
  • Number of participants with new onset depression as assessed by new prescriptions for antidepressants [ Time Frame: 12 months post-procedure ]
    New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization
  • Number of participants with new onset depression as assessed by new prescriptions for antidepressants [ Time Frame: 24 months post-procedure ]
    New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization
  • Number of participants with new onset depression as assessed by new prescriptions for antidepressants [ Time Frame: 36 months post-procedure ]
    New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization
  • Number of participants with new onset depression as assessed by new prescriptions for antidepressants [ Time Frame: 48 months post-procedure ]
    New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization
  • Number of participants with new onset depression as assessed by new prescriptions for antidepressants [ Time Frame: 60 months post-procedure ]
    New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization
  • Pre-sterilization clinical variables associated with procedural complications [ Time Frame: Up to 1-year pre-sterilization ]
    Identify sociodemographic and pre-sterilization clinical variables which may predict complications following hysteroscopic sterilization compared to laparoscopic sterilization.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization
Official Title Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization
Brief 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 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

Study Aims:

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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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).
Condition
  • Sterility, Female
  • Contraception
  • Contraceptive Device; Complications
Intervention
  • Device: Essure
    Essure hysteroscopic sterilization
  • Procedure: Laparoscopic sterilization
    Laparoscopic sterilization via electrocautery, ring, or clip.
  • Device: Intrauterine Device (IUD)
    Intrauterine Device (IUD)
Study Groups/Cohorts
  • Essure Hysteroscopic Sterilization
    Women who have undergone Essure hysteroscopic sterilization
    Intervention: Device: Essure
  • Laparoscopic Sterilization
    Women who have undergone laparoscopic sterilization
    Intervention: Procedure: Laparoscopic sterilization
  • Intrauterine device (IUD) placement
    Women who have undergone IUD placement
    Intervention: Device: Intrauterine Device (IUD)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: February 12, 2018)
23000
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 31, 2020
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Women aged 18-50 years at the time of sterilization procedure
  • Claims indicating hysteroscopic or laparoscopic sterilization procedures or IUD placement

Exclusion Criteria:

  • Active cancer
  • Any conditions that would have excluded the patient for hysteroscopic sterilization
  • Any conditions that would have excluded the patient for laparoscopic sterilization
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03438682
Other Study ID Numbers 2000020734
1U01FD005938-01 ( U.S. FDA Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Yale University
Study Sponsor Yale University
Collaborators
  • University of California, Davis
  • National Center for Health Research
  • Patient-Centered Outcomes Research Institute
  • Food and Drug Administration (FDA)
Investigators
Principal Investigator: Aileen Gariepy, MD Yale University
PRS Account Yale University
Verification Date May 2020