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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03438682
Other study ID # 2000020734
Secondary ID 1U01FD005938-01
Status Completed
Phase
First received
Last updated
Start date September 30, 2018
Est. completion date July 31, 2021

Study information

Verified date November 2021
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 89203
Est. completion date July 31, 2021
Est. primary completion date July 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Essure
Essure hysteroscopic sterilization
Procedure:
Laparoscopic sterilization
Laparoscopic sterilization via electrocautery, ring, or clip.
Device:
Intrauterine Device (IUD)
Intrauterine Device (IUD)

Locations

Country Name City State
United States Yale University School of Medicine New Haven Connecticut

Sponsors (5)

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

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a) Pregnancy after sterilization or IUD placement, indicating failure Pregnancy rates at 60 months post-procedure
Secondary 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
Secondary 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 6 months post-procedure
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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