A Pilot Study of Early Expulsion Rates of the IUB™ SCu380A (IUB)

August 26, 2019 updated by: Wiebe, Ellen, M.D.

A Pilot Study of Early Expulsion Rates of the IUB™ SCu380A Spherical Copper Intrauterine Contraceptive Device.

The IUB (Intrauterine ball) is a copper releasing intrauterine contraceptive device consisting of copper beads on a flexible NiTinol wire. It was designed to reduce the pain and bleeding caused by traditional T-shaped copper IUDs and to reduce expulsions. In an initial pilot of 15 women, there were no complications during the 12 months. This observational pilot study of 50 women will determine that the early expulsion rate is not greater than 10% and that there is patient and physician acceptance, so that we can plan a larger randomized controlled trial for efficacy and safety.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z1H9
        • Willow Women's Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • requesting non-hormonal intrauterine contraception
  • able to return for ultrasound in 6-8 weeks

Exclusion Criteria:

  • History of recent pelvic inflammatory disease
  • Known anemia
  • Dysfunctional uterine bleeding
  • Malignancy or suspected malignant disease of female inner or outer genitalia
  • Known intolerance or allergy to copper and/or copper IUDs
  • Any other significant disease or condition that could interfere with the subject's ability to complete the protocol
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IUB
There is one arm of women who will have IUBs inserted
Device: IUB
intrauterine contraceptive device
Other Names:
  • SCu380A IUB™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expulsion Rate
Time Frame: at 6-8 weeks
The device being expelled from the uterus as documented by ultrasound or by seeing the actual device outside the uterus
at 6-8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication
Time Frame: 12 months
infection, perforation, pregnancy
12 months
Acceptability
Time Frame: 12 months
patient-reported acceptability
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wiebe, Ellen, M.D.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

October 26, 2013

First Submitted That Met QC Criteria

October 26, 2013

First Posted (Estimate)

November 1, 2013

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

August 26, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 130928 IUB

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Clinical Study Report

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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