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| ID | Type | Description | Link |
|---|---|---|---|
| IUDvsPlanBforEC |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | IUD |
|
| 2 | Active Comparator | Oral levonorgestrel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copper T380 IUD | Drug | Copper T380 IUD |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy | positive urine pregnancy test at anytime within 6 months of presenting for emergency contraception. | 6 months |
| Infection | diagnosis and treatment for pelvic inflammatory disease |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Turok, MD/MPH | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood Association of Utah, West Valley City Clinic | West Valley City | Utah | 84119 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Copper T380 IUD | IUD |
| FG001 | Levonorgestrel | Oral levonorgestrel |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Copper T380 IUD | IUD |
| BG001 | Levonorgestrel | Oral levonorgestrel |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Copper T380 IUD | IUD |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Turok, MD | University of Utah | 801-581-7647 | david.turok@hsc.utah.edu |
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| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 |
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| levonorgestrel | Drug | 1.5 mg |
|
|
| 6 months |
| 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. | 6 months |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Pregnancy | positive urine pregnancy test at anytime within 6 months of presenting for emergency contraception. | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Infection | diagnosis and treatment for pelvic inflammatory disease | Posted | Number | participants | 6 months |
|
|
|
| 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. | Posted | Number | participants | 6 months |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Levonorgestrel | Oral levonorgestrel | 0 | 34 | 0 | 34 |
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| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |