Copper T380 IUD Versus Oral Levonorgestrel for Emergency Contraception vs. Plan B for Emergency Contraception

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Study of Copper T380A IUDs Versus Oral Levonorgestrel for Emergency Contraception

Conditions
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Pregnancy

Intervention / Treatment
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* Drug: Copper T380 IUD
* Drug: levonorgestrel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>IUD | Drug: Copper T380 IUD<br>* Copper T380 IUD<br>* Other names: Paragard IUD;|
| Active Comparator: 2<br>Oral levonorgestrel | Drug: levonorgestrel<br>* 1.5 mg<br>* Other names: Plan B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contraception, emergency contraception, pregnancy prevention after unprotected intercourse