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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| unprotected intercourse 6-14 days prior to contraception | Women who initiate highly effective reversible contraception within 6-14 days of unprotected intercourse. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copper T-380 IUD | Drug |
|
| |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Women presenting to IRB approved clinics requesting highly effective contraception (an IUD, Nexplanon®, or Depo-Provera) .
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| Name | Affiliation | Role |
|---|---|---|
| David Turok, MD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood Association of Utah | West Valley City | Utah | 84119 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16488819 | Background | Sadler LS, Chen JY, Daley AM, Leventhal JM, Reynolds H. Reproductive care and rates of pregnancy in teenagers with negative pregnancy test results. J Adolesc Health. 2006 Mar;38(3):222-9. doi: 10.1016/j.jadohealth.2004.10.007. | |
| 19305327 | Background | Schwarz EB, Kavanaugh M, Douglas E, Dubowitz T, Creinin MD. Interest in intrauterine contraception among seekers of emergency contraception and pregnancy testing. Obstet Gynecol. 2009 Apr;113(4):833-839. doi: 10.1097/AOG.0b013e31819c856c. |
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| ID | Term |
|---|---|
| D017258 | Medroxyprogesterone Acetate |
| C020884 | DEPO |
| ID | Term |
|---|---|
| D008525 | Medroxyprogesterone |
| D006908 | Hydroxyprogesterones |
| D011374 | Progesterone |
| D011282 | Pregnenediones |
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| LNG IUD |
| Drug |
|
|
| Contraceptive implant Nexplanon | Device |
|
|
| Depo-Provera | Drug |
|
|
| 12384200 | Background | Westhoff C, Kerns J, Morroni C, Cushman LF, Tiezzi L, Murphy PA. Quick start: novel oral contraceptive initiation method. Contraception. 2002 Sep;66(3):141-5. doi: 10.1016/s0010-7824(02)00351-7. |
| 33706343 | Derived | Boraas CM, Sanders JN, Schwarz EB, Thompson I, Turok DK. Risk of Pregnancy With Levonorgestrel-Releasing Intrauterine System Placement 6-14 Days After Unprotected Sexual Intercourse. Obstet Gynecol. 2021 Apr 1;137(4):623-625. doi: 10.1097/AOG.0000000000004118. |
| D011283 |
| Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |