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Completed

NCT Number: NCT03438682

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 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.

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Key information

Conditions

Sterility, Female Contraception Contraceptive Device; Complications Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Infertility, Female Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

About this study

Study Aims:

Aim 1. To compare the real world effectiveness of hysteroscopic sterilization, laparoscopic sterilization and intrauterine devices (IUDs) by calculating:

  • Pregnancy rates at 3, 6, 12, 24, 36, 48, and 60 months post-procedure, indicating sterilization failure.
  • 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:

  • 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.
  • 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).
  • Identify sociodemographic and pre-sterilization clinical variables which may predict complications following hysteroscopic sterilization compared to laparoscopic sterilization and to IUDs.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Essure

Device

Essure hysteroscopic sterilization

Laparoscopic sterilization

Procedure

Laparoscopic sterilization via electrocautery, ring, or clip.

Intrauterine Device (IUD)

Device

Intrauterine Device (IUD)

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Food and Drug Administration (FDA)
  • National Center for Health Research
  • Patient-Centered Outcomes Research Institute
  • University of California, Davis

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 20, 2018
Registry last updated
Nov 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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