Clinical trial NCT04071392: Development of an Intrauterine Pressure Threshold to Confirm Tubal Occlusion
Official title: Pressure Dynamics in the Non-gravid Uterus: Development of an Intrauterine Pressure Threshold to Confirm Tubal Occlusion After Nonsurgical Permanent Contraception
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sterilization, Female
Fallopian Tube Occlusion
Keywords: hysterosalpingogram (HSG)
permanent contraception
tubal occlusion
tubal patency
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Womens Imaging & Intervention
First posted: 2019-08-28
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Reproductive age (18-50 years) women in the Portland-metro area with either a history of Essure® hysteroscopic permanent contraception or healthy control participants without history of a permanent contraception procedure.

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 tubes are a passage that allows fluid and cells to flow between the body cavity and the uterus. Normally, both tubes are open to this flow, a condition called "tubal patency". If one or both tubes is blocked preventing flow of fluid, this is called "tubal occlusion". If there is tubal patency, as the pressure increases in the uterine cavity, fluid will move through the tubes into the body cavity. If the tubes are occluded, pressure will increase in the uterus but the fluid will not move into the tubes.

The long-term goal is to develop an alternative test to confirm both fallopian tubes are blocked after a non-surgical permanent contraception (sterilization) procedure. Currently tubal patency is determined by HSG.

In this study, the investigators evaluate the potential for alternative diagnostic office tests. The study will evaluate whether uterine pressure measurements can predict tubal patency, or whether the change in volume following intrauterine administration of a fixed volume of saline followed by aspiration predicts tubal patency.

Prior to the instillation of contrast solution, investigators will administer a fixed volume of saline at a constant rate until we reach a volume of 10 ml, or the limit of tolerability for the patient. After a wait of 1 min, they will attempt to aspirate the saline, and measure the difference between fluid in and fluid out. The study will also measure intrauterine pressure during the procedure.

Following the saline test, an HSG is done to assess tubal patency.

This study will evaluate healthy parous women in the late follicular phase and women with a history of Essure permanent contraception.

The investigators hypothesize that women with a history of Essure will have higher uterine pressure, higher volume of fluid recovered, and bilateral tubal occlusion by HSG.

Eligibility criteria: Inclusion Criteria:

1. Literate in English
2. Ages 18-50 years
3. No history of infertility, and current regular menstrual cycles occurring every 24-37 days
4. At least one full-term vaginal delivery
5. Not be at risk for pregnancy
6. 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)
7. Willing to undergo intrauterine saline infusion followed by a single HSG procedure
8. Able to understand and sign approved study informed consent form
9. Willing to complete a pre-procedure questionnaire

Exclusion Criteria:

1. Currently pregnant as confirmed by positive high-sensitivity urine pregnancy test
2. Currently using an intrauterine device (IUD) or contraceptive implant
3. Hypersensitive to radio-opaque contrast
4. History of cesarean section
5. History of tubal ligation by a method other than Essure® or Adiana
6. History recognized as clinically significant by the investigator, such as symptoms of untreated or recent pelvic infection

Primary outcomes:
measure: Intrauterine Fluid Volume Lost
timeFrame: 5 minutes
Secondary outcomes:
measure: Tolerance of 10 ml Saline Infusion
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Jeffrey Jensen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: