Intrauterine Devices, Copper, Menstrual Cycle, Menstruation, Metrorrhagia
Conditions
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.
Interventions
DEVICET380A 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.
Sponsors
University of Utah
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 3 months prior to insertion, month 1-month 3 , month 4-month 6 | 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
| Measure | Time frame | Description |
|---|---|---|
| Assess the Relationship of Menstrual Cycle Changes Among Women Initiating the Copper T380 IUD to Method Satisfaction and Continuation at 6 Months Post Insertion. | 6-month 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 | 6 months | % of individuals reporting that their new method had neutral or positive impact of their new contraceptive on their sex life across time points. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 78 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Failed IUD Insertion | 1 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | T380A Copper IUD |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 78 Participants |
| Age, Continuous | 25.4 years STANDARD_DEVIATION 5.2 |
| Race/Ethnicity, Customized Black/African American | 2 Participants |
| Race/Ethnicity, Customized Hispanic | 7 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Race/Ethnicity, Customized South Pacific Islander | 5 Participants |
| Race/Ethnicity, Customized White | 66 Participants |
| Region of Enrollment United States | 78 Participants |
| Sex: Female, Male Female | 78 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 78 |
| other Total, other adverse events | 0 / 78 |
| serious Total, serious adverse events | 0 / 78 |
Outcome results
Primary
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.
Time frame: 3 months prior to insertion, month 1-month 3 , month 4-month 6
Population: Healthy Women ages 18-40 with menstrual cycle lengths between 21 and 35 days and menses lasting 3 to 7 days, and completed follow up were eligible for participation and analysis. Women were excluded if they reported use of any hormonal contraception in the previous 3 months.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| T380A Copper IUD | 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. | 3 months prior to insertion | 4.5 days of bleeding |
| T380A Copper IUD | 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. | month 1-month3 | 6.0 days of bleeding |
| T380A Copper IUD | 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. | month 4-month 6 | 5.5 days of bleeding |
Comparison: The null hypothesis is that there is no difference between the number of days of bleeding per month at baseline and the days of bleeding per month during 90 days after insertion, and months or 91-180 days following insertion.p-value: <0.0595% CI: [1.2, 2.3]ANOVA
Comparison: The estimation parameter compares the 90 days following to the 90 days prior.p-value: <0.0595% CI: [0.36, 1.5]t-test, 2 sided
Secondary
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.
Time frame: 6-month post insertion
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T380A Copper IUD | Assess the Relationship of Menstrual Cycle Changes Among Women Initiating the Copper T380 IUD to Method Satisfaction and Continuation at 6 Months Post Insertion. | satisfied | 51.6 percent of patients |
| T380A Copper IUD | Assess the Relationship of Menstrual Cycle Changes Among Women Initiating the Copper T380 IUD to Method Satisfaction and Continuation at 6 Months Post Insertion. | continuing | 6.4 percent of patients |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| T380A Copper IUD | Assess the Relationship of Menstrual Cycle Changes Among Women Initiating the Copper T380 IUD to Sexual Functioning and Satisfaction | 80 percentage of participants |