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Development of an Intrauterine Pressure Threshold to Confirm Tubal Occlusion

NCT ID: NCT04071392

Last Updated: 2019-12-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-01

Study Completion Date

2017-07-31

Brief Summary

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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

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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.

Conditions

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Sterilization, Female Fallopian Tube Occlusion

Keywords

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hysterosalpingogram (HSG) permanent contraception tubal occlusion tubal patency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Post-Essure Group

Healthy women with history of Essure hysteroscopic permanent contraception.

Eligible participants will then undergo the HSG imaging study - a standard radiological imaging study to determine that the fallopian tubes are open and free of disease. It also checks the uterine cavity for any abnormalities.

Hysterosalpingogram (HSG)

Intervention Type PROCEDURE

An infusion pump delivered saline via balloon catheter under continuous pressure monitoring. After one minute, investigators withdraw the fluid and recorded volumes in and out. Subjects then undergo hysterosalpingogram (HSG) for evaluation of tubal patency.

Control Group

Healthy women with no history of permanent contraception.

Eligible participants will then undergo the HSG imaging study - a standard radiological imaging study to determine that the fallopian tubes are open and free of disease. It also checks the uterine cavity for any abnormalities.

Hysterosalpingogram (HSG)

Intervention Type PROCEDURE

An infusion pump delivered saline via balloon catheter under continuous pressure monitoring. After one minute, investigators withdraw the fluid and recorded volumes in and out. Subjects then undergo hysterosalpingogram (HSG) for evaluation of tubal patency.

Interventions

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Hysterosalpingogram (HSG)

An infusion pump delivered saline via balloon catheter under continuous pressure monitoring. After one minute, investigators withdraw the fluid and recorded volumes in and out. Subjects then undergo hysterosalpingogram (HSG) for evaluation of tubal patency.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Womens Imaging & Intervention

OTHER

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Jeffrey Jensen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeffrey Jensen, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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OHSU IRB 11443

Identifier Type: -

Identifier Source: org_study_id