Quick Start of Highly Effective Contraception

Study Overview
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Brief Summary
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This project will quantify rates of contraceptive failure when unprotected intercourse occurs 6-14 days prior to initiation of highly effective reversible contraceptives (such as IUD's and Implants).

Detailed Description
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Women seeking emergency contraception (EC) frequently report multiple recent episodes of unprotected sex. Although high sensitivity urine pregnancy tests effectively rule-out pregnancy resulting from sex that occurred more than 14 days ago, clinicians are frequently concerned that pregnancy may result from unprotected sex that occurred <14 days prior to IUD placement. Placement of a copper IUD within 5 days of unprotected sex is a highly effective form of EC. Among 52 Chinese women who reported unprotected intercourse 5-7 days prior to copper IUD insertion, no pregnancies occurred. However, the effectiveness of the copper IUD when unprotected sex occurs 7-14 days prior to IUD placement is unknown. Intrauterine pregnancies rarely occur with a copper IUD in place. As some clinicians are concerned about injuring a pregnancy that occurs with an IUD in place, women who have had unprotected sex 7-14 days prior to requesting IUD placement are typically told they must use another, less effective, contraceptive for 2+ weeks and then return to obtain an IUD. To remove this barrier to emergency placement of a copper IUD, we propose to study rates of pregnancy when a copper IUD is placed any time a urine pregnancy test is negative. We believe that simplifying guidance regarding the recommended timing of copper IUD placement has the potential to significantly increase the number of women offered same-day IUD service.

Official Title
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Rates of Contraceptive Failure When Unprotected Intercourse Has Occurred 6-14 Days Prior to Contraceptive Initiation

Conditions
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IUD, Contraceptive Implant, Contraception, Birth Control, Emergency Contraception

Intervention / Treatment
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* Drug: Copper T-380 IUD
* Drug: LNG IUD
* Device: Contraceptive implant Nexplanon
* Drug: Depo-Provera


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women between the ages of 15 and 45 years who request injectable, subdermal, or intrauterine contraception, 6-14 days after having unprotected intercourse. Exclusion Criteria: History of tubal ligation or hysterectomy. Positive urine pregnancy test

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| unprotected intercourse 6-14 days prior to contraception<br>Women who initiate highly effective reversible contraception within 6-14 days of unprotected intercourse. | Drug: Copper T-380 IUD<br> <br> * Other names: Paragard IUD;Drug: LNG IUD<br> <br> * Other names: Mirena IUD, Skyla IUD;Device: Contraceptive implant Nexplanon<br> <br> * Other names: Etonorgestrel contraceptive implant, Implanon, Nexplanon;Drug: Depo-Provera<br> <br> * Other names: Depo, Intramuscular medroxyprogesterone acetate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rates in the first month of contraceptive use | This study is designed to provide clinicians and their patients with information regarding rates of contraceptive failure (i.e. undesired pregnancy) when contraception is initiated or placed for a woman who has a negative pregnancy test, but reports having had unprotected intercourse 6-14 days prior to requesting contraception. | 4 weeks from contraception initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Highly Effective Contraception, Emergency Contraception, Birth Control, LARC (Long Acting Reversible Contraception), HERC (Highly Effective Contraception)