Induced Abortion, Intrauterine Device Expulsion, Medical Abortion
Conditions
Keywords
Intrauterine Device, Induced Abortion, Medical Abortion
Brief summary
The purpose of this study is to determine the expulsion and continuation rate of an intruterine device (IUD) placed immediately after medical abortion. Our hypothesis is that immediate-placement of an IUD after completed medical abortion will have a similar expulsion and continuation rate to traditional placement (4-6 weeks after pregnancy).
Detailed description
Women who seek abortion care often desire more effective or longer- lasting contraception. Intrauterine devices are as efficacious as tubal ligation, require no on-going effort on the woman's part to protect her from pregnancy, and are underutilized in the US. We are interested in determining whether placement of an intreatuereine device (IUD) at the time of confirming the completion of a medical abortion may have similar expulsion and continuation rates as IUDs placed after pregnancy (usually a 4-6 week time period). If this is the case, women may save the time and effort of yet another clinic visit, as well as have immediate protection against pregnancy after their abortion. FDA labeling does not specify or restrict time of insertion and therefore this study is in compliance with FDA labeling.
Interventions
DEVICEIUD insertion [Copper T-380A or Levonorgestrel (intrauterine system) IUS]
When a subject has chosen a method of intra-uterine contraception and has agreed to participate in the study, she will have the intra-uterine device of her choice inserted according to the Food and Druga Administration (FDA) instructions.
Sponsors
University of Utah
Boston University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Women who completed a medical abortion in the last 14 days * At least 18 years old. * Desiring long-term contraception with an IUD. * Able and willing to give consent for participation in research. * Gonorrhea and chlamydia screen negative within 60 days of entry to study. * Willing to comply with the study requirements. * Accessible by telephone.
Exclusion criteria
* Had pelvic inflammatory disease or a septic abortion within the past 3 months or gonorrheal or chlamydial infection in the last 60 days. * Allergy to copper, or Wilson's disease (for Paragard; may have Mirena) * Intracavitary of symptomatic uterine fibroids. * Ovarian, cervical or endometrial cancer. * Severe anemia (defined as hgb \< 8).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Women With Expulsion of an Intrauterine Device (IUD) Placed After Medical Abortion. | Three months |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Women Continuing IUD Use at 3 Months | 3 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Observation- All Subjects Women choosing intra-uterine contraception after medical abortion. | 120 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 23 |
Baseline characteristics
| Characteristic | Observation- All Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 120 Participants |
| Age Continuous | 28 years STANDARD_DEVIATION 4 |
| Region of Enrollment United States | 120 participants |
| Sex: Female, Male Female | 120 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 118 |
| serious Total, serious adverse events | 0 / 118 |
Outcome results
Primary
Percentage of Women With Expulsion of an Intrauterine Device (IUD) Placed After Medical Abortion.
Time frame: Three months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Single Arm Study | Percentage of Women With Expulsion of an Intrauterine Device (IUD) Placed After Medical Abortion. | 4 percentage of participants |
Secondary
Percentage of Women Continuing IUD Use at 3 Months
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Single Arm Study | Percentage of Women Continuing IUD Use at 3 Months | 80. percentage of participants |