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Tracking IUD Bleeding Experiences: An Evaluation of Bleeding Profiles in New Intrauterine Device Users (TRIBE)

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ClinicalTrials.gov Identifier: NCT02311478
Recruitment Status : Completed
First Posted : December 8, 2014
Results First Posted : July 30, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
David Turok, University of Utah

Brief Summary:
This study aims to use validated tools as well as new technology to examine changes in bleeding patterns among women who are initiating the copper T380A IUD.

Condition or disease Intervention/treatment Phase
Intrauterine Devices, Copper Metrorrhagia Menstruation Menstrual Cycle Device: T380A Intrauterine Copper Contraceptive Not Applicable

Detailed Description:

New users of the intrauterine device (IUD) are most likely to discontinue use within the first six months after insertion. The most common reason for discontinuation of the copper IUD is symptoms related to bleeding. Research looking at disturbances in bleeding patterns among new IUD users is sparse and dated. Perceived changes in vaginal bleeding may impact method satisfaction, acceptability, and continuation. There is a need for updated research evaluating changes in bleeding patterns in order for providers to better counsel patients on what to expect during the months after initiation of an IUD.

A variety of methods to evaluate bleeding profiles are available. The World Health Organization (WHO) published recommendations for methods of collection and analysis of bleeding patterns. The WHO method includes data collection on bleeding days (days when blood loss requires the use of a menstrual pad or tampon) and spotting days (when no protection was needed) using 90-day referent periods. A second tool, the pictorial blood loss assessment chart (PBAC) has been shown to be an inexpensive and objective method of assessing blood loss. The PBAC takes into consideration how heavy blood flow is as well as the number of sanitary napkins and tampons used. Additionally, new technologies (including mobile period tracking applications) have made retrospective collection of bleeding data more feasible and prospective data collection more accurate.

This study aims to incorporate these validated tools as well as new technology to examine changes in bleeding patterns among women who are initiating the copper T380A IUD.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: (TRIBE) Tracking IUD Bleeding Experiences: An Evaluation of Bleeding Profiles in New Intrauterine Device Users
Study Start Date : December 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: T380A Copper IUD
All participants will receive a T380A copper intrauterine device when enrolled. They can continue using the device for as long as they wish. The study will be completed when 6 months of prospective bleeding data has been collected.
Device: T380A Intrauterine Copper Contraceptive
The T380A is intrauterine device (IUD) that used to prevent pregnancy. It is a soft, flexible T-shaped device made primarily of plastic and copper that is inserted into the uterus.
Other Name: Paragard




Primary Outcome Measures :
  1. Evaluate Changes in Bleeding Duration Among Women Initiating the Copper T380 IUD During the 90 Days Prior to Initiation Compared to Two 90 Periods After IUD Insertion. [ Time Frame: 3 months prior to insertion, month 1-month 3 , month 4-month 6 ]
    Evaluate bleeding duration among women initiating the copper T380 IUD during the 90 days prior to initiation compared to two 90 periods after IUD insertion. Women will track bleeding after the insertion of the T380A IUD for 180 days. Participants will be contacted monthly to collect data.


Secondary Outcome Measures :
  1. Assess the Relationship of Menstrual Cycle Changes Among Women Initiating the Copper T380 IUD to Method Satisfaction and Continuation at 6 Months Post Insertion. [ Time Frame: 6-month post insertion ]
    Determine rates of continuation and level of satisfaction with the IUD during the first 6 months of use.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy women ages 18-40 years with regular, normal menses (lasting between 3-7 days) and who are initiating an IUD
  • Women who can provide bleeding information for 3 cycles off of any hormonal contraception (or non-hormonal IUD) and are willing to track bleeding for 180 days
  • Women who are between 6 and 12 months postpartum (if they have had normal menses the last 3 cycles)

Exclusion Criteria:

  • Use of any hormonal contraceptive method in the previous 3 months
  • Irregular duration of menstrual cycles in the last 3 cycles (<21 or >35 days)
  • Recent history of menstrual bleeding lasting less than 3 days or greater than 7 days based on self report of the last 3 cycles
  • Contraindication to use of the ParaGard® T380A IUD
  • Mucopurulent cervicitis at the time of IUD insertion
  • Unable to speak, read, and write in English
  • Currently pregnant
  • Plans for or desire for pregnancy in the next 6 months
  • Currently breastfeeding
  • Women who are <6 months postpartum
  • Participation in any clinical investigation utilizing an investigational drug or medical device or requiring invasive gynecologic procedures within the 30 days prior to enrollment
  • Wilson's disease
  • Known coagulopathy or bleeding disorder

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 ClinicalTrials.gov identifier (NCT number): NCT02311478


Locations
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United States, Utah
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: David Turok, MD Unviersity of Utah

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Responsible Party: David Turok, MD, University of Utah
ClinicalTrials.gov Identifier: NCT02311478     History of Changes
Other Study ID Numbers: 75363
First Posted: December 8, 2014    Key Record Dates
Results First Posted: July 30, 2019
Last Update Posted: July 30, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Metrorrhagia
Hemorrhage
Pathologic Processes
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Copper
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Nutrients
Growth Substances