Tracking IUD Bleeding Experiences: An Evaluation of Bleeding Profiles in New Intrauterine Device Users (TRIBE)
Primary Purpose
Intrauterine Devices, Copper, Metrorrhagia, Menstruation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
T380A Intrauterine Copper Contraceptive
Sponsored by
About this trial
This is an interventional supportive care trial for Intrauterine Devices, Copper
Eligibility 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
Sites / Locations
- University of Utah Health Sciences Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
T380A Copper IUD
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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
Assess the Relationship of Menstrual Cycle Changes Among Women Initiating the Copper T380 IUD to Method Satisfaction and Continuation at 6 Months Post Insertion.
Determine rates of continuation and level of satisfaction with the IUD during the first 6 months of use.
Assess the Relationship of Menstrual Cycle Changes Among Women Initiating the Copper T380 IUD to Sexual Functioning and Satisfaction
# of individuals reporting that their new method had neutral or positive impact of their new contraceptive on their sex life across time points.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02311478
Brief Title
Tracking IUD Bleeding Experiences: An Evaluation of Bleeding Profiles in New Intrauterine Device Users
Acronym
TRIBE
Official Title
(TRIBE) Tracking IUD Bleeding Experiences: An Evaluation of Bleeding Profiles in New Intrauterine Device Users
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrauterine Devices, Copper, Metrorrhagia, Menstruation, Menstrual Cycle
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
T380A Copper IUD
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
T380A Intrauterine Copper Contraceptive
Other Intervention Name(s)
Paragard
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
3 months prior to insertion, month 1-month 3 , month 4-month 6
Secondary Outcome Measure Information:
Title
Assess the Relationship of Menstrual Cycle Changes Among Women Initiating the Copper T380 IUD to Method Satisfaction and Continuation at 6 Months Post Insertion.
Description
Determine rates of continuation and level of satisfaction with the IUD during the first 6 months of use.
Time Frame
6-month post insertion
Title
Assess the Relationship of Menstrual Cycle Changes Among Women Initiating the Copper T380 IUD to Sexual Functioning and Satisfaction
Description
# of individuals reporting that their new method had neutral or positive impact of their new contraceptive on their sex life across time points.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Turok, MD
Organizational Affiliation
Unviersity of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah Health Sciences Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Tracking IUD Bleeding Experiences: An Evaluation of Bleeding Profiles in New Intrauterine Device Users
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