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

Completed

• Conditions: Contraception; Contraceptive Device; Complications; Sterility, Female
• Interventions: Device: Intrauterine Device (IUD); Device: Essure; Procedure: Laparoscopic sterilization

• Registration Number: NCT03438682
• Lead Sponsor: Yale University

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 Timeline

• Study First Submitted: 2018-01-29
• Study First Submitted QC: 2018-02-12
• Study First Posted: 2018-02-20
• Study Start: 2018-09-30
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-01
• Last Update Posted: 2021-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 89203

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intrauterine device (IUD) placement	Intrauterine Device (IUD)	Women who have undergone IUD placement
Essure Hysteroscopic Sterilization	Essure	Women who have undergone Essure hysteroscopic sterilization
Laparoscopic Sterilization	Laparoscopic sterilization	Women who have undergone laparoscopic sterilization

Primary Outcome Measures

Name	Time	Method
Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a)	Pregnancy rates at 60 months post-procedure	Pregnancy after sterilization or IUD placement, indicating failure

Secondary Outcome Measures

Name	Time	Method
Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b)	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
Pre-procedure clinical variables associated with procedural complications	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
Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy)	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	60 months post-procedure	New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement
Reoperation to achieve sterilization or reinsertion to achieve IUD placement	60 months post-procedure	Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement
Number of participants with new onset depression as assessed by new prescriptions for antidepressants	60 months post-procedure	New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement

Trial Locations

Locations (1)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States