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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Intrauterine Devices, Copper, Metrorrhagia, Menstruation, Menstrual Cycle

Intervention / Treatment
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* Device: T380A Intrauterine Copper Contraceptive


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T380A Copper IUD<br>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<br>* 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.<br>* Other names: Paragard;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months prior to insertion, month 1-month 3 , month 4-month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6-month post insertion | 
| 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. | 6 months |