Status:
COMPLETED
Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization
Lead Sponsor:
Yale University
Collaborating Sponsors:
University of California, Davis
National Center for Health Research
Conditions:
Sterility, Female
Contraception
Eligibility:
FEMALE
18-50 years
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 Fallopia...
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, ...
Eligibility Criteria
Inclusion
- Women aged 18-50 years at the time of sterilization procedure
- Claims indicating hysteroscopic or laparoscopic sterilization procedures or IUD placement
Exclusion
- Active cancer
- Any conditions that would have excluded the patient for hysteroscopic sterilization
- Any conditions that would have excluded the patient for laparoscopic sterilization
Key Trial Info
Start Date :
September 30 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2021
Estimated Enrollment :
89203 Patients enrolled
Trial Details
Trial ID
NCT03438682
Start Date
September 30 2018
End Date
July 31 2021
Last Update
November 3 2021
Active Locations (1)
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1
Yale University School of Medicine
New Haven, Connecticut, United States, 06510