N/A
Completed N=24
Development of an Intrauterine Pressure Threshold to Confirm Tubal Occlusion
Sterilization, Female · Fallopian Tube Occlusion
Source: ClinicalTrials.gov NCT04071392 ↗
Enrolled (actual)
24
Serious AEs
—
Results posted
Dec 2019
Primary outcomePrimary: Intrauterine Fluid Volume Lost — 2.2; 7.8 ml
Summary
The overarching goal of this study is to find an alternative method to hysterosalpingogram (HSG) to confirm bilateral tubal occlusion after permanent contraception.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intrauterine Fluid Volume Lost |
2.2; 7.8 | — |
| SECONDARY Tolerance of 10 ml Saline Infusion |
0; 5; 10; 5 | — |
Eligibility Criteria
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
- Willing to complete a pre-procedure questionnaire
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
Data sourced from ClinicalTrials.gov (NCT04071392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.