This trial is active, not recruiting.

Conditions intrauterine devices, copper, metrorrhagia, menstruation, menstrual cycle
Treatment t380a intrauterine copper contraceptive
Sponsor University of Utah
Start date December 2014
End date August 2016
Trial size 80 participants
Trial identifier NCT02311478, 75363


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose supportive care
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.
t380a intrauterine copper contraceptive Paragard
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 Outcomes

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

Secondary Outcomes

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
Assess the relationship of menstrual cycle changes among women initiating the copper T380 IUD to sexual functioning and satisfaction.
time frame: 180 days

Eligibility Criteria

Female participants from 18 years up to 40 years old.

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

Additional Information

Official title (TRIBE) Tracking IUD Bleeding Experiences: An Evaluation of Bleeding Profiles in New Intrauterine Device Users
Principal investigator David Turok, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Utah.