NCT03438682

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 89,203 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sterility, Female
• Contraception
• Contraceptive Device; Complications

Interventions

Type	Name	Description
DEVICE	Essure	Essure hysteroscopic sterilization
PROCEDURE	Laparoscopic sterilization	Laparoscopic sterilization via electrocautery, ring, or clip.
DEVICE	Intrauterine Device (IUD)	Intrauterine Device (IUD)

Timeline

• Start date: 2018-09-30
• Primary completion: 2021-07-31
• Completion: 2021-07-31
• First posted: 2018-02-20
• Last updated: 2021-11-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study