Quick Start of Highly Effective Contraception
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| unprotected intercourse 6-14 days prior to contraception Women who initiate highly effective reversible contraception within 6-14 days of unprotected intercourse. |
Drug: Copper T-380 IUD
Other Names:
Drug: LNG IUD
Other Names:
Device: Contraceptive implant Nexplanon
Other Names:
Drug: Depo-Provera
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Planned Parenthood Association of Utah | West Valley City | Utah | United States | 84119 |
Sponsors and Collaborators
- University of Utah
Investigators
- Principal Investigator: David Turok, MD, University of Utah
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 67314