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

NCT03438682 | Completed FDA Device

• 2 other identifiers: 20000207341U01FD005938-01
• Study Type: observational
• Target: 89,203
• Locations: 1 country
• Sites: 1

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.

Conditions

Sterility, Female; Contraception; Contraceptive Device; Complications

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (36)

• Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b)

  3 months post-procedure

• Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b)

  6 months post-procedure

• Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b)

  12 months post-procedure

• Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b)

  24 months post-procedure

• Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b)

  36 months post-procedure

Study Arms (3)

Essure Hysteroscopic Sterilization

Women who have undergone Essure hysteroscopic sterilization

Device: Essure

Laparoscopic Sterilization

Women who have undergone laparoscopic sterilization

Procedure: Laparoscopic sterilization

Intrauterine device (IUD) placement

Women who have undergone IUD placement

Device: Intrauterine Device (IUD)

Interventions

Essure DEVICE

Essure hysteroscopic sterilization

Essure Hysteroscopic Sterilization

Laparoscopic sterilization PROCEDURE

Laparoscopic sterilization via electrocautery, ring, or clip.

Laparoscopic Sterilization

Intrauterine Device (IUD) DEVICE

Intrauterine Device (IUD)

Intrauterine device (IUD) placement

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

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

You may not qualify if:

• Active cancer
• Any conditions that would have excluded the patient for hysteroscopic sterilization
• Any conditions that would have excluded the patient for laparoscopic sterilization

Sponsors & Collaborators

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

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Related Publications (3)

• Gariepy AM, Lewis C, Zuckerman D, Tancredi DJ, Murphy E, McDonald-Mosley R, Sonalkar S, Hathaway M, Nunez-Eddy C, Schwarz EB. Comparative effectiveness of hysteroscopic and laparoscopic sterilization for women: a retrospective cohort study. Fertil Steril. 2022 Jun;117(6):1322-1331. doi: 10.1016/j.fertnstert.2022.03.001. Epub 2022 Apr 12.

  PMID: 35428480 DERIVED

• Schwarz EB, Lewis CA, Dove MS, Murphy E, Zuckerman D, Nunez-Eddy C, Tancredi DJ, McDonald-Mosley R, Sonalkar S, Hathaway M, Gariepy AM. Comparative Effectiveness and Safety of Intrauterine Contraception and Tubal Ligation. J Gen Intern Med. 2022 Dec;37(16):4168-4175. doi: 10.1007/s11606-022-07433-4. Epub 2022 Feb 23.

  PMID: 35194746 DERIVED

• Gariepy AM, Lewis C, Zuckerman D, Tancredi DJ, Murphy E, McDonald-Mosley R, Sonalkar S, Hathaway M, Nunez-Eddy C, Schwarz EB. Patient-Centered Safety Outcomes After Hysteroscopic Compared With Laparoscopic Sterilization. Obstet Gynecol. 2022 Mar 1;139(3):423-432. doi: 10.1097/AOG.0000000000004690.

  PMID: 35115444 DERIVED

Related Links

• This work was (partially) supported through a Patient-Centered Outcomes Research Institute (PCORI) Award 1609-36359

MeSH Terms

Conditions

Infertility, Female

Interventions

Intrauterine Devices

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Contraceptive Devices, Female; Contraceptive Devices; Equipment and Supplies

Study Officials

• Aileen Gariepy, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 20, 2018
• Study Start: September 30, 2018
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: November 3, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)