Pregnancy
Conditions
Keywords
contraception, emergency contraception, pregnancy prevention after unprotected intercourse
Brief summary
The purpose of this study is to see if women presenting for emergency contraception (EC) are willing to accept the copper intrauterine device (IUD). This study will also compare the use of effective methods of contraception between women who selected the copper IUD or Plan B 6 months after they received EC.
Detailed description
This study seeks to estimate the acceptance of Copper IUD use amongst people presenting for EC. This will be accomplished by offering all women who present for EC at participating Planned Parenthood Association of Utah (PPAU) clinics during the study period the option of having the copper IUD or Plan B. Women who agree to study participation will be followed for 6 months. The primary outcome for the study is the use of a reliable method of contraception 6 months after presenting for EC. Secondary outcomes measured will be pregnancies, abortions, repeat Plan B use, presence of gonorrhea or Chlamydia infection at the time of presentation for EC, number of days to first bleeding episode and duration of that bleeding episode, further bleeding patterns, frequency of unprotected intercourse, use of a barrier method for prevention of sexually transmitted infections, patient satisfaction with the chosen method and symptoms possibly related to contraception use. Patients selecting the IUD will be assessed for IUD expulsion, perforation, and removal.
Interventions
DRUGCopper T380 IUD
Copper T380 IUD
DRUGlevonorgestrel
1.5 mg
Sponsors
University of Utah
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Women 18-45 years old, in need of EC (had unprotected intercourse within 120 hours), willing to give consent for participation in research, willing to comply with the study requirements, and accessible by telephone. * Patients selecting the IUD need to identify themselves as desiring long-term contraception.
Exclusion criteria
* Current pregnancy, * Had pelvic inflammatory disease or a septic abortion within the past 3 months or gonorrheal or chlamydial infection in the last 60 days, * Current behavior suggesting a high risk for pelvic inflammatory disease * Allergy to copper, or Wilson's disease (for patients selecting Paragard) or allergy to levonorgestrel (for patients selecting Plan B) * Intracavitary of symptomatic uterine fibroids, and abnormalities of the uterus that distort the uterine cavity, * Mucopurulent cervicitis, * A previously placed IUD that has not been removed * Genital bleeding of unknown etiology * Ovarian, cervical or endometrial cancer, * Small uterine cavity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception | 6 months | Use of a method of contraception with a typical efficacy rate \>= to 92%. This includes combined hormonal contraception (combined oral contraceptive pills, the contraceptive patch and ring), sterilization, IUDs, Depo-provera, and contraceptive implants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy | 6 months | positive urine pregnancy test at anytime within 6 months of presenting for emergency contraception. |
| Infection | 6 months | diagnosis and treatment for pelvic inflammatory disease |
| IUD Expulsion, Removal, or Perforation | 6 months | patient reports IUD expulsion, removal, or perforation OR one of these events was documented at the clinic where patient received care. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Copper T380 IUD IUD | 23 |
| Levonorgestrel Oral levonorgestrel | 34 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 10 | 12 |
Baseline characteristics
| Characteristic | Levonorgestrel | Copper T380 IUD | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 23 Participants | 57 Participants |
| Age, Continuous | 23.0 years STANDARD_DEVIATION 4.7 | 24.7 years STANDARD_DEVIATION 6.7 | 23.7 years STANDARD_DEVIATION 5.6 |
| Region of Enrollment United States | 34 participants | 23 participants | 57 participants |
| Sex: Female, Male Female | 34 Participants | 23 Participants | 57 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 23 | 0 / 34 |
| serious Total, serious adverse events | 0 / 23 | 0 / 34 |
Outcome results
Primary
Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception
Use of a method of contraception with a typical efficacy rate \>= to 92%. This includes combined hormonal contraception (combined oral contraceptive pills, the contraceptive patch and ring), sterilization, IUDs, Depo-provera, and contraceptive implants.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Copper T380 IUD | Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception | 9 participants |
| Levonorgestrel | Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception | 13 participants |
Secondary
Infection
diagnosis and treatment for pelvic inflammatory disease
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Copper T380 IUD | Infection | 0 participants |
| Levonorgestrel | Infection | 0 participants |
Secondary
IUD Expulsion, Removal, or Perforation
patient reports IUD expulsion, removal, or perforation OR one of these events was documented at the clinic where patient received care.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Copper T380 IUD | IUD Expulsion, Removal, or Perforation | 5 participants |
| Levonorgestrel | IUD Expulsion, Removal, or Perforation | 0 participants |
Secondary
Pregnancy
positive urine pregnancy test at anytime within 6 months of presenting for emergency contraception.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Copper T380 IUD | Pregnancy | 0 participants |
| Levonorgestrel | Pregnancy | 2 participants |