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

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.

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