Status:
COMPLETED
Development of an Intrauterine Pressure Threshold to Confirm Tubal Occlusion
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Womens Imaging & Intervention
Conditions:
Sterilization, Female
Fallopian Tube Occlusion
Eligibility:
FEMALE
18-50 years
Brief Summary
The overarching goal of this study is to find an alternative method to hysterosalpingogram (HSG) to confirm bilateral tubal occlusion after permanent contraception.
Detailed Description
The hystero-(uterus)salpingo-(fallopian tube)graphy (HSG) study is a standard radiological imaging study used to evaluate the internal female reproductive parts, the uterus and fallopian tubes. The tu...
Eligibility Criteria
Inclusion
- Literate in English
- Ages 18-50 years
- No history of infertility, and current regular menstrual cycles occurring every 24-37 days
- At least one full-term vaginal delivery
- Not be at risk for pregnancy
- Be willing to undergo a one month washout period if using the pill, patch or ring, or a three month wash out period if using Depo-Medroxyprogesterone acetate (DMPA)
- Willing to undergo intrauterine saline infusion followed by a single HSG procedure
- Able to understand and sign approved study informed consent form
- Willing to complete a pre-procedure questionnaire
Exclusion
- Currently pregnant as confirmed by positive high-sensitivity urine pregnancy test
- Currently using an intrauterine device (IUD) or contraceptive implant
- Hypersensitive to radio-opaque contrast
- History of cesarean section
- History of tubal ligation by a method other than Essure® or Adiana
- History recognized as clinically significant by the investigator, such as symptoms of untreated or recent pelvic infection
Key Trial Info
Start Date :
September 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2017
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04071392
Start Date
September 1 2016
End Date
July 31 2017
Last Update
December 10 2019
Active Locations (1)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239