CompletedNot Applicable

Development of an Intrauterine Pressure Threshold to Confirm Tubal Occlusion

United States24 participantsStarted 2016-09-01

Plain-language summary

The overarching goal of this study is to find an alternative method to hysterosalpingogram (HSG) to confirm bilateral tubal occlusion after permanent contraception.

Who can participate

Age range18 Years – 50 Years

SexFEMALE

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Intrauterine Fluid Volume Lost

Timeframe: 5 minutes

Trial details

NCT IDNCT04071392

SponsorOregon Health and Science University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-07-31

Results submitted2019-11-13

View on ClinicalTrials.gov More Sterilization, Female trials