Quick Start of Highly Effective Contraception
- Conditions
- Birth ControlIUDContraceptive ImplantContraceptionEmergency Contraception
- Interventions
- Registration Number
- NCT02076217
- Lead Sponsor
- University of Utah
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 1030
- Women between the ages of 15 and 45 years who request injectable, subdermal, or intrauterine contraception, 6-14 days after having unprotected intercourse.
- History of tubal ligation or hysterectomy.
- Positive urine pregnancy test
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description unprotected intercourse 6-14 days prior to contraception LNG IUD Women who initiate highly effective reversible contraception within 6-14 days of unprotected intercourse. unprotected intercourse 6-14 days prior to contraception Copper T-380 IUD Women who initiate highly effective reversible contraception within 6-14 days of unprotected intercourse. unprotected intercourse 6-14 days prior to contraception Contraceptive implant Nexplanon Women who initiate highly effective reversible contraception within 6-14 days of unprotected intercourse. unprotected intercourse 6-14 days prior to contraception Depo-Provera Women who initiate highly effective reversible contraception within 6-14 days of unprotected intercourse.
- Primary Outcome Measures
Name Time Method Pregnancy rates in the first month of contraceptive use 4 weeks from contraception initiation 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Planned Parenthood Association of Utah
🇺🇸West Valley City, Utah, United States