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
Last Update Posted : October 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Intrauterine Devices, Copper Metrorrhagia Menstruation Menstrual Cycle||Device: T380A Intrauterine Copper Contraceptive||Not Applicable|
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.
|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|
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
- Evaluate changes in frequency, duration, and quantity of bleeding patterns among women initiating the copper T380 IUD during the 90 days prior to initiation compared to two 90 periods after IUD insertion. [ Time Frame: 180 days ]Women will track bleeding after the insertion of the T380A IUD for 180 days. Participants will be contacted monthly to collect data.
- Assess the relationship of menstrual cycle changes among women initiating the copper T380 IUD to method satisfaction, acceptability, and continuation at 6 months post insertion. [ Time Frame: 180 days ]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. [ Time Frame: 180 days ]Use reported measures at baseline, 1 month, 3 months, and 6 months to examine the relationship between bleeding patterns and sexual satisfaction.
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
|United States, Utah|
|University of Utah Health Sciences Center|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||David Turok, MD||Unviersity of Utah|