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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01973777
Recruitment Status : Completed
First Posted : November 1, 2013
Results First Posted : February 2, 2016
Last Update Posted : September 6, 2019
Information provided by (Responsible Party):
Wiebe, Ellen, M.D.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Contraception Device: IUB Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: intrauterine contraceptive device IUB
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Study of Early Expulsion Rates of the IUB™ SCu380A Spherical Copper Intrauterine Contraceptive Device.
Actual Study Start Date : December 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Experimental: IUB
There is one arm of women who will have IUBs inserted
Device: IUB
intrauterine contraceptive device
Other Name: SCu380A IUB™

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Complication [ Time Frame: 12 months ]
    infection, perforation, pregnancy

  2. Acceptability [ Time Frame: 12 months ]
    patient-reported acceptability

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01973777

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Canada, British Columbia
Willow Women's Clinic
Vancouver, British Columbia, Canada, V5Z1H9
Sponsors and Collaborators
Wiebe, Ellen, M.D.
Study Data/Documents: Clinical Study Report  This link exits the site

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Responsible Party: Wiebe, Ellen, M.D. Identifier: NCT01973777    
Other Study ID Numbers: 130928 IUB
First Posted: November 1, 2013    Key Record Dates
Results First Posted: February 2, 2016
Last Update Posted: September 6, 2019
Last Verified: August 2019
Keywords provided by Wiebe, Ellen, M.D.:
intrauterine device, contraception