Development of an Intrauterine Pressure Threshold to Confirm Tubal Occlusion

NCT04071392 | Completed Results

• 1 other identifier: OHSU IRB 11443
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Sterilization, Female; Fallopian Tube Occlusion

Keywords

hysterosalpingogram (HSG); permanent contraception; tubal occlusion; tubal patency

Outcome Measures

Primary Outcomes (1)

• Intrauterine Fluid Volume Lost

  After placement of the hysterosalpingogram catheter, investigators use an infusion pump to deliver normal saline under continuous pressure monitoring until reaching one of the following endpoints: delivery of the entire volume of 10mL (milliliter); a peak pressure of 450mmHg (millimeters of Mercury); or the participant requested the infusion to stop due to intolerable discomfort. After one minute, investigators withdraw the delivered fluid through the hysterosalpingogram catheter and record the volume instilled and recovered. They then repeat the procedure using contrast under fluoroscopy to confirm tubal patency or occlusion.

  5 minutes

Secondary Outcomes (1)

• Tolerance of 10 ml Saline Infusion

  5 minutes

Study Arms (2)

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.

Procedure: Hysterosalpingogram (HSG)

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.

Procedure: Hysterosalpingogram (HSG)

Interventions

Hysterosalpingogram (HSG) 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; Post-Essure Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Womens Imaging & Intervention: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Results Point of Contact

• Title: OB/Gyn Regulatory Specialist
• Organization: Oregon Health & Science University

whru@ohsu.edu

503-494-3666

Study Officials

• Jeffrey Jensen, MD, MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: August 28, 2019
• Study Start: September 1, 2016
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: December 10, 2019
• Results First Posted: December 10, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 12 months after publication
• Access Criteria: Must have Oregon Health \& Science University (OHSU) Institutional Review Board (IRB) approval

Locations

US (1)