N/A
N=24
Development of an Intrauterine Pressure Threshold to Confirm Tubal Occlusion
Sterilization, Female · Fallopian Tube Occlusion
Bottom Line
View on ClinicalTrials.gov: NCT04071392 ↗Enrolled (actual)
24
Serious AEs
—
Results posted
Dec 2019
Primary outcome: Primary: Intrauterine Fluid Volume Lost — 2.2; 7.8 ml
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Hysterosalpingogram (HSG) (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Oregon Health and Science University
- Primary completion
- Jul 2017
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 | — |
Summary
The overarching goal of this study is to find an alternative method to hysterosalpingogram (HSG) to confirm bilateral tubal occlusion after permanent contraception.
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.