The Copper T380A IUD vs. Oral Levonorgestrel 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) and choose the copper intrauterine device (IUD) will have fewer unplanned pregnancies in the next year compared to women who choose oral levonorgestrel for EC. The study will also compare use of an effective method of contraception in the year after they received EC.

Detailed Description
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All women presenting to 2 Planned Parenthood Association of Utah clinics in Salt Lake City will be offered participation in this study. Women will select either the copper IUD or oral levonorgestrel for EC. The primary outcome is unplanned pregnancy in the year following presentation for EC. Secondary outcomes include use of an effective method of contraception over the next year, abortions, repeat use of EC, number of days to first bleeding episode and duration of that bleeding episode, use of a barrier method to prevent sexually transmitted infections, patient satisfaction with the chosen method of EC and contraception. Participants selecting the IUD will be assessed for IUD expulsion, perforation, and removal.

Official Title
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Preventing Future Pregnancy After Choosing the Copper IUD vs. Oral Levonorgestrel for Emergency Contraception

Conditions
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Pregnancy

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women 18-30 years old, in need of emergency contraception (had unprotected intercourse within 120 hours), willing to give consent for participation in research, willing to comply with study requirements, and accessible by telephone. Participants selecting the IUD need to identify themselves as desiring long-term contraception. Exclusion Criteria: Current pregnancy Had pelvic inflammatory disease or septic abortion within the past 3 months or had gonorrhea or chlamydia infection in the last 60 days Current behavior suggesting a high risk for pelvic inflammatory disease Allergy to copper or Wilson's disease (for participants selecting the copper IUD) or allergy to levonorgestrel (for participants selecting oral levonorgestrel) Abnormalities of the uterus that distort the uterine cavity Mucopurulent cervicitis A previously placed IUD that has not been removed Genital bleeding of an unknown etiology Ovarian, cervical, or endometrial cancer Small uterine cavity (< 6cm)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IUD<br>Women presenting for emergency contraception who select the copper IUD | Drug: Copper T380 IUD<br>* copper T 380 IUD<br>* Other names: Paragard IUD;|
| Oral levonorgestrel<br>Women presenting for emergency contraception who select oral levonorgestrel | Drug: Oral 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 |
| --- | --- | --- |
| Unplanned pregnancy |  | within 12 months of presenting for EC | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of an effective method of contraception in the year following use of emergency contraception. |  | 12 months | 
| IUD expulsion, removal or perforation |  | 12 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